Activity of 30 different cheeses on cholesterol plasma levels and Oxidative Balance Risk Index (OBRI) in a rat model.

BACKGROUND: Cheese is considered to increase the total cholesterol levels (CH) due to the high-saturated fat content. New models are needed to measure the relationship between cholesterol and cheese. METHODS: Thirty different cheeses produced in Val Brembana, Italy ("furmai da mut", "caprino" and "stracchino"), were added to the diet of 30 groups of 4 rats. Cheeses were analyzed to differentiate the volatile organic compounds (VOCs) and the cholesterol content (Ch(f)). The body weight, CH, urine volume and oxidative balance were measured. Three new indexes in relation to CH were calculated: OI (oxidative index), PI (protective index) and OBRI (oxidative balance risk index). RESULTS: None of the cheeses increased CH. Some of the "furmai de mut" were significantly decreasing CH and improved the oxidative balance. Ch(f) was not affecting the CH levels in plasma. In terms of VOCs, the acetic acid content was correlated (p < 0.05) with the CH reduction and PI improvement. OBRI was reduced mainly in the "stracchino group". CONCLUSIONS: The model shows that some cheese can reduce significantly CH levels and improve the antioxidant capacity.

Validation of a patented method to determine the antioxidant capacity of human saliva based on the reduction of iron: the SAT test.

BACKGROUND: The defense against damaging attack at mouth level caused by reactive species, in particular reactive oxygen species (ROS), is guaranteed by saliva, the main constituent of the antioxidant barrier. The aim of the performed tests was to establish the precision, linearity, and accuracy of the new patented test, SAT, on saliva samples taken from healthy volunteers. The analysis also provided useful information on storage conditions of the sample at low temperatures and on the normality range and defined the influences of interferences (in particular phosphates) in the determination. METHODS: Sixty apparently healthy volunteers were selected to verify the antioxidant capacity of the oral cavity using the new patented SAT method. RESULTS: SAT performed on 70 saliva samples demonstrated that the test was precise, linear (R = 0.9994), accurate, and reproducible (CV 4.39%). The SAT values in the saliva samples analyzed had a normal distribution with a control range for healthy subjects of 947-1459 micromol/L. The fundamental presence of a particular salt in the SAT solutions allowed avoidance of phosphate interference and eliminated false positives. CONCLUSIONS: SAT can be considered an important predictive test not only for periodontal disease, caries, gingivitis, and general pathologies related to oral cavity, but also for systemic diseases such as: cardiovascular diseases, diabetes, Alzheimer's disease, and others.

Intestinal fat absorption shifting by polyglucosamine biopolymer: control of lipids and reduction of progression of early subclinical atherosclerosis.

BACKGROUND: Atherosclerosis progression is possible in subjects with limited alteration of body weight, lipid profile, and oxidative stress. The ultrasound carotid thickness (IMT) and arterial wall modification (granulation and bubbles) are evident signs of the disease. Intestinal fats absorption shifting (IFAS) is expected to prevent or reduce the arterial damage. The aim of the registry was to evaluate the effects of a mild diet in association with lifestyle modifications (standard management [SM]) and SM+ a polyglucosamine biopolymer (BP) shifting the intestinal absorption of dietary fats. METHODS: The present is a two-year registry comparing two groups of otherwise healthy subjects, respectively 150 (SM) and 144 (SM+BP). BP was administered at the dosage of 3g/day. IMT and relative arterial damages were measured together with lipid profile, oxidative stress, anthropometric and vital measures. RESULTS: The two groups at the baseline were comparable for all variables: 8 cases of drop out were found limited to SM. Compliance with BP was optimal (>97%) and no side effect were observed. IMT showed a significant decrease in thickness (P<0.05) using BP+SM, while increased in SM group. Intimal granulations and lipid wall bubbles were also significantly decreased with BP in comparison to SM only (P<0.05). BMI significantly decreased with BP (P<0.05) as well as BW, fat mass, lipid profile and oxidative stress in comparison to SM only. A positive variation in blood pressure and heart rate (P<0.05) was also observed. CONCLUSIONS: BP allows IFAS to improve early subclinical arterial lesions that tend to progress to plaques and clinical events. The long-term and safe treatment of BP is effective on IMT, lipids, BW, and early lesions of the arterial wall structure in subjects with subclinical conditions. BP also reduces oxidative stress which contributes to lipid oxidation and deposition into the arterial wall layer in areas of high dynamic stress (arterial bifurcations).

Borderline hyperlipidemia preventive management with Berberine PL in asymptomatic prevention of early atherosclerosis.

BACKGROUND: The aim of this pilot, efficacy supplement registry was to use a supplementary management with berberine to control hyperlipidemia. The supplement Berberine (Berbevis™ as Sophy® tablets) was used to control lipids and to evaluate (as a natural, preventive management) the early evolution of subclinical atherosclerosis in subjects (otherwise healthy, not using drugs) with borderline hyperlipidemia. METHODS: The registry involved two groups of subjects not using drugs for a total of 50 subjects and three months of supplementation. RESULTS: The registry groups using standard management (SM) or SM and supplement were resulted comparable. No side effects were observed during the three months of berberine supplementation. No tolerability problems were reported. All subjects managed with berberine completed the three-month registry. Compliance was >97% (% of correctly used tablets). Total cholesterol was significantly decreased with berberine (P<0.05) and HDL was significantly improved (P<0.5) with supplementation. Triglycerides decreased in the berberine groups (P<0.05) and the levels of CoQ10 remained within normal values in supplemented subjects. Oxidative stress - measured in Carr units - was significantly decreased with berberine (P<0.05). Routine blood tests remained within normal values during the registry. Body weight was significantly more decreased (P<0.05) with berberine in comparison with standard management. The fat proportion also decreased (P<0.05) with berberine supplementation and the abdominal fat thickness (in the peri-umbilical area) was significantly decreased after berberine supplementation (P<0.05). CONCLUSIONS: This pilot registry indicates that berberine administration is effective in reducing lipids (decreasing weight, fat percentage and abdominal fat) in otherwise healthy subjects not using drugs. A longer study, with more advanced hyperlipidemic subjects is suggested. Predictive analytics according to Siegel suggests that a six-month study with 60 patients, in more advanced hyperlipidemic, also evaluating the intima-media thickness for the analysis of vascular benefits, may produce a stronger evaluation for this product.

Pycnogenol® improves cognitive function in post-stroke patients: a 6 month-study.

BACKGROUND: This pilot study in post-stroke patients evaluated the effects of supplementation with Pycnogenol® on alterations in cognitive functions (COFU) over a period of 6 months, starting 4 weeks after the stroke. METHODS: The effects of supplementation - possibly acting on residual brain edema, on global cognitive function, attention and on mental performance - were studied. A control group used standard management (SM) and the other group added Pycnogenol®, 150 mg daily to SM. RESULTS: 38 post-stroke patients completed the 6-month-study, 20 in the Pycnogenol® group and 18 in the control group. No side effects were observed with the supplement. The tolerability was very good. The patients included into the two groups were comparable for age, sex and clinical distribution. There were 2 dropouts in the control group, due to non-medical problems. Main COFU parameters (assessed by a cognitive questionnaire) were significantly improved (all single items) with the supplement compared to controls (P<0.05). Additional observations indicate that Pycnogenol® patients experienced significantly less mini-accidents (including falls) than controls (P<0.05). The incidences of (minor) psychotic episodes or conflicts and distress and other problems including rare occurrence of minor hallucinations, were lower with the supplementation than in controls (P<0.05). Single observations concerning daily tasks indicated a better effect of Pycnogenol® compared to controls (P<0.05). Plasma free radicals also decreased significantly with the supplement in comparison to controls (P<0.05). Globally, supplemented subjects had a better recovery than controls. CONCLUSIONS: In post-stroke subjects, Pycnogenol® supplementation resulted in better recovery outcome and faster COFU 'normalization' after the stroke in comparison with SM; it can be considered a safe, manageable post-stroke, adjuvant management possibly reducing local brain edema. Nevertheless, more patients and a longer period of evaluation are needed to confirm these results.

Pycnogenol® supplementation to relieve symptoms after hemorrhoidectomy.

BACKGROUND: Hemorrhoids are a common problem associated with symptoms, like swelling, local thrombosis and generally with a decreased quality of life, often in otherwise healthy subjects. Hemorrhoids can be classified by grades (I to IV) according to their severity. In this registry study subjects treated with excisional hemorrhoidectomy (EH) for the first time, were included. After surgery, edema tends to complicate surgical areas causing relevant symptoms. Most hemorrhoids symptoms are related to alterations in bowel habits. Increase in diet fibers to avoid constipation, exercise, and limiting straining reduce recurrence after surgery. METHODS: The aim of the registry study was to evaluate the effects of Pycnogenol® (Horphag Research, Geneva, Switzerland) on relieving postoperative symptoms following hemorrhoidectomy. Pycnogenol® 150 mg/day was used between one month before surgery up to one month after surgery. The main postoperative symptoms were scored. RESULTS: Thirty-eight subjects completed the 60-day supplement registry study. Eighteen subjects were supplemented with Pycnogenol® in addition to the standard management (SM) and 20 subjects only received SM and were considered as controls. The two groups were comparable for age, sex and main symptoms distribution and for their clinical characteristics at inclusion. No other disease was present. The scores for pain, discomfort, and constipation were significantly lower with the supplement compared to controls (P<0.05) 10 and 30 days after surgery. In addition, the quality-of-life score was higher with Pycnogenol® (P<0.05) while bleeding (minimal, not clinically evaluable) and a possible residual anal stenosis (requiring a longer period of observation) were barely observed. A satisfactory return to activity was observed 30 days after surgery in the 18 subjects using Pycnogenol®, and in only 15 out of 20 patients (75%) in the control group (P<0.05). All Pycnogenol® subjects were able to drive and perform daily tasks in comparison with 14 out of 20 subjects in the control group. The proportion of patients that took pain medication from day 10 to 30 post-surgery was significantly lower in the Pycnogenol® group than in controls (P<0.05). CONCLUSIONS: In this post-surgical pilot, registry study, Pycnogenol® was effective in preventing and controlling postoperative symptoms after hemorrhoidectomy. To confirm the results, more cases are needed, including different surgical methods and clinical conditions. Mucosal and cutaneous edema and perianal swelling - generally seen after surgery - seem to be clearly reduced with Pycnogenol® and the supplement intake was associated with a more regular and pain-controlled convalescence and healing.

Pycnogenol® prevents skin hyperpigmentation following sclerotherapy.

BACKGROUND: The aim of this registry supplement study was to evaluate the effects of the oral supplement Pycnogenol® on possible skin discolorations or other minor skin changes after varicose vein sclerotherapy in comparison with a standard management (SM). METHODS: One hundred sixty-one subjects completed the study. 84 took Pycnogenol® from the day before sclerotherapy for 12 weeks and followed SM. 77 followed SM only and served as controls. 420 injection sites were followed-up in the Pycnogenol® group and 431 in the control group. The number of injected veins (using only Aetoxysklerol) was on average 4-8 veins/patient. No side effects were observed for the SM or for supplementation. Pycnogenol® supplementation showed a good tolerability. The two management groups were comparable for age, sex and veins distribution at inclusion. RESULTS: After 12 weeks, skin discoloration assessed by a skin staining score was generally significantly lower and less frequent (P<0.05) with Pycnogenol® with a score of 0.4±0.2 compared to controls (with a score of 2.1±0.4). In addition, the number of stains per treated vein was significantly lower in the Pycnogenol® group than the control group. CONCLUSIONS: Varicose vein sclerotherapy is a minimally invasive procedure almost without complications. Pycnogenol® intake appears to improve healing and prevent skin discolorations after injection of the sclerosing agent. To verify this effect of Pycnogenol®, more studies for a longer period are needed.

Prevention and control of jet lag symptoms and temporary impairment of cognitive function with Pycnogenol® in healthy individuals and in hypertensives.

BACKGROUND: The aim of this registry study was to evaluate the efficacy of Pycnogenol® in controlling signs/symptoms and temporary impairment of cognitive function (COFU) associated with jet lag. Previous flight studies have shown a decrease in the level of jet lag symptoms with Pycnogenol®. The control of jet lag signs/symptoms appeared to be correlated with flight-related microangiopathy and peripheral edema. Pycnogenol® - a standardized extract from the bark of French maritime pine - has significant antiedema, anti-inflammatory and antioxidant properties. METHODS: A group of subjects flying east in economy class for 10-12 hours used Pycnogenol® 150 mg/day and a similar group without supplementation served as controls. A subgroup of mild hypertensive subjects using a single ACE inhibitor was also included. RESULTS: One hundred twenty-seven subjects completed the study. Of the participants, 48 were aviation professionals like pilots, flight attendants or air company staff - 24 of them took Pycnogenol® and 24 served as controls. Forty-seven study participants were frequent flyers and non-staff professionals, 25 of which took Pycnogenol® and 22 served as controls. In addition, a group of 32 subjects with mild hypertension was included, 16 took Pycnogenol® and 16 served as controls. No side effects and a good tolerability were observed. The registry groups were comparable for baseline characteristics. Eastbound flights' duration was 11.22±0.4 hours in supplemented subjects and 11.14±0.32 in controls. Dropouts were due to logistical problems. Post flight Visual Analogue Scale (VAS) scores were significantly lower in all Pycnogenol® groups, including hypertensives for all signs and symptoms of jet lag compared to controls, showing prevention and improvement of jet lag symptoms. The duration of any sign/symptom of jet lag with Pycnogenol® intake was significantly shorter (P<0.05) post-flight compared to controls (P<0.05). The number of nights of altered/disturbed sleep was also lower in the Pycnogenol® groups compared to controls. Leg edema was present in almost all subjects with different degrees especially in the hypertensive group. The increase in ankle circumference before and after flight was significantly lower with Pycnogenol® compared to controls (P<0.05). After the flight, average scores of the single COFU tasks were significantly higher in the Pycnogenol® groups compared to controls, showing preserved cognitive function. CONCLUSIONS: In conclusion, in this registry study Pycnogenol® was effective in preventing jet lag-related symptoms and preserving cognitive functions without tolerability problems. These observations should be tested in a larger group of subjects including complex individuals prone to edema (i.e. diabetics, hypertensive or older patients).

Analysis of oxidative stress during the menstrual cycle.

BACKGROUND: Few data concerning the oxidative stress (OS) in plasma during the entire menstrual cycle of eumenorrheic women are available. METHODS: OS was assessed in 20 healthy volunteers during the phase of the menstrual cycle by determining the plasmatic hydroperoxides levels (d-ROMs test). The assessment was performed every three days, starting from the first day (t1) up the end of the menstrual phase (t27). Concomitantly, the estrogen (E2) and progestin (P4) levels were determined at the same time intervals. RESULTS: From a base value (t1) of 284 +/- 38.0 CARR.U., which is essentially within the normal range (<300 Carratelli units or CARR.U.), the OS levels progressively increased to 378 +/- 115 CARR.U. at t15, and then slightly decreased over the subsequent time but with average values >300 CARR.U. Analysis of the E2 levels showed that the maximum OS values were noticed near the estrogen peak, while remaining above the base levels, and then decreased during the progestin phase until returning to normal at the end of the menstrual cycle. CONCLUSIONS: It may concludes that the healthy women go into OS for 2/3 of the menstrual cycle.

Levothyroxine and lung cancer in females: the importance of oxidative stress.

BACKGROUND: Levothyroxine (LT4) treatment can lead to iatrogenic hyperthyroidism and oxidative stress that can cause patient discomfort. Oxidative stress is also recognized as one of the causes of chronic diseases and cancer. METHODS: The prevalence of breast, colorectal, gastric and lung cancer in 18 Italian Regions during 2010 was correlated with the sales of LT4 in 2009. The cancer prevalence was analyzed in women aged 30-84. This age range corresponds to more than 80% of the consumers of the drug and to about 99% of all malignant cancers. The correlation between sales of LT4 and cancers was determined with the technique of Density Ellipses. The age and smoking contribution for lung cancer was determined with the Sequential test. RESULTS: No significant correlation was seen between LT4 sales and breast, colorectal and gastric cancers. A significant correlation was instead found for lung cancer (p<0.05) corrected for smoking and age. CONCLUSIONS: LT4 consumption in Italy is about 0.7 boxes/women/year. There is a correlation between lung cancer and LT4 treatment and oxidative stress caused by LT4 supplementation can be one of the causes. Although we cannot exclude that dysthyroidism needing LT4 supplementation might be the ground for lung cancer itself and measuring oxidative stress could be helpful in avoiding excessive use of the drug.

Performance evaluation of the innovative PAT test, comparison with the common BAP test and influence of interferences on the evaluation of the plasma antioxidant capacity.

BACKGROUND: Antioxidants (AOs) represent the main barrier of defense against damaging aggression due to reactive species, in particular by reactive oxygen species (ROS). The plasma AO capacity is a measure of physiological, environmental, and nutritional factors (exposure to ROS and antioxidant supplementation) determining the redox status in humans and can underline the oxidative stress (OS) conditions in the progression/development of many diseases. Moreover, changes in AO plasma content after supplementation may provide information on the absorption and bioavailability of nutritional compounds and efficacy of AO therapy. AIM: The aim of the study was a comparison between the common BAP (Biological Antioxidant Potential) test, used for the evaluation of the antioxidant capacity, and the innovative PAT (Plasma Antioxidant Test) and to assess both the in vitro interferences of phosphates on the iron reduction and the interference of the plasmatic concentration of phosphates in relation to the plasma antioxidant capacity measured with the two methods. METHODS: Thirty-six apparently healthy volunteers were involved in the study for the comparison of the two methods. RESULTS: BAP test and PAT performed on 36 plasma samples demonstrated that plasma antioxidant capacity dosage using the BAP test resulted in overestimated levels in relation to plasma phosphate. Increased BAP values due to phosphates correspond to increased differences between BAP and PAT value (correlation coefficient R = 0.812, p = 0.001). CONCLUSIONS: PAT can be considered an innovative and predictable method for the measure of the antioxidant power of plasma.

Intestinal fat absorption shifting: polyglucosamine biopolymer controls lipids and weight and reduces the progression of subclinical atherosclerosis.

BACKGROUND: Intestinal fat absorption shifting (IFAS) can be obtained in hyperlipidemic subjects with polyglucosamine biopolymer (BP) able to segregate most metabolic fats in the gut, making them unavailable for intestinal interaction (shift). The aim of this study was to evaluate the effects of a SM (standard management) for hyperlipidemia in asymptomatic subjects for primary cardiovascular prevention focusing on arterial wall morphology (IMT thickness) in comparison to SM associated to the administration of the BP. METHODS: Two groups of comparable subjects (SM and SM+oral BP, 3 g/day) were considered; subjects were managed - in a supplement, pilot registry - for a year. Weight, fat mass, lipid profile, oxidative stress, IMT (carotids), the presence of granulations at the internal arterial layers and "near wall low density 'bubbles' were observed and compared at 1 year of management. A non-parallel, comparable group of subjects (102) using a statin for the same conditions was used as a reference population. RESULTS: Two hundred eighty-four subjects completed one year (140 in the SM group and 144 in the SM+BP group). Compliance was optimal with (96.3% of the table correctly used) with no side effects. BMI, fat mass and oxidative stress decreased more in the SM+BP group (P<0.05). Cholesterol and triglycerides levels were significantly improved with BP (P<0.05). IMT measurements were significantly decreased (P<0.05) in the SM+BP group (as for the intimal granulation/bubbles) with minimal variations in the comparative SM group. In the statin group, the lipid profile was modified (P<0.05) but not the IMT and the rate of drop outs was higher (15.7%); these patients stopped the management; in 23% of these subjects muscular pain not seen with BP, was observed. CONCLUSIONS: These results indicate positive effects of IFAS due to BP on IMT and arterial wall morphology and weight after 12 months. Fat shifting at intestinal level and the reduction of oxidative stress limit lipid oxidation/deposition into the arterial wall.

Correction to: Intestinal fat absorption shifting: polyglucosamine biopolymer controls lipids and weight and reduces the progression of subclinical atherosclerosis.

This article was published in Volume 69, issue 1 of publishing year 2023, with a mistake in Table I. The correct Table I is the one included in this erratum.

Positive effects of Pycnogenol®-Centellicum® on venous elasticity: an ex-vivo concept study.

BACKGROUND: The aim of this ex-vivo study was to evaluate the efficacy of Pycnogenol®-Centellicum® oral supplementation on vein segments, retrieved from graft harvesting or from vein surgery. The parameters assessed were elasticity and recovery after dynamic tests: 1) an enlargement stress; 2) an elongation stress; and 3) elasticity after torsion. The tests were made in standardized conditions, less than 3 hours after explant, at 22 °C by the same operator with surgical and microsurgical experience. METHODS: Veins of 59 subjects were included in the study: 17 subjects with normal veins with a planned bypass graft and 42 subjects with varicose veins. Of the subjects with normal veins, 8 subjects followed standard management (group 1) and 9 took Pycnogenol®-Centellicum® for 4 weeks before surgery (group 2). In the group with varicose veins, 22 subjects served as controls (group 3) and 20 were supplemented with Pycnogenol®-Centellicum® for 4 weeks before surgery (group 4). No side effects or tolerability problems were observed in the supplementation period before surgery and veins harvesting. The full return to initial shape/sizes after dynamic stress was evaluated in 1 min after removing the stress. RESULTS: In group 1, 4 out of 8 vein segments recovered their size after forced enlargement vs. 7/9 in the Pycnogenol®-Centellicum® group 2 (P<0.05). In the elongation test, 3/8 normal control vein segments recovered their length (group 1) vs. 7/9 in the supplement group (group 2) (P<0.05). In the torsion test, 4/8 (group 1) veins recovered their shape after torsion vs. 9/9 veins in Pycnogenol®-Centellicum®-pretreated segments (group 2) (P<0.05). Only 45.8% of normal, control vein segments (group 1) recovered their shape/size in comparison with 85.2% of normal vein segments in the supplement group (group 2) (P<0.05). In group 3 and 4 (segments of varicose veins), the proportion of vein segments with enlargements, elongation and torsion were significantly lower at the end of the test (P<0.05) in the Pycnogenol®-Centellicum® group 4 with 51.7% of the vein segments recovering their shape in the Pycnogenol®-Centellicum® vs. 16.6% of the vein segments recovering their shape in control segments (P<0.05). Results show that Pycnogenol®-Centellicum® supplementation allows vein segments to better return to their original shape/size after a morphological alteration of shape (in different directions). This could be an expression of an improved wall tone and elasticity of the veins. No vein was teared or damaged during the 59 tests indicating that all stresses were well within the normal wall tensile characteristics of the veins. CONCLUSIONS: In this study, Pycnogenol®-Centellicum® improved vein elasticity in subjects with normal and varicose veins as vein segments were more elastic (able to recover length and shape) and less passively dilated by high pressure or dynamic stresses. This study indicates that the protective effects of Pycnogenol®-Centellicum® may partially stop passive dilatation of veins to varicose veins over time by improving vein elasticity. Pycnogenol®-Centellicum® managed vein segments return more rapidly back to the initial dimensions, shapes and diameters after a dynamic stress.

Robuvit® reduces fatigue after chemotherapy for colon cancer. A pilot registry study.

BACKGROUND: The aim of this pilot registry study was to evaluate the efficacy of Robuvit® (oak wood extract) on residual fatigue due to convalescence in otherwise healthy subjects within one month after surgery and chemotherapy for colon cancer. Robuvit® has been clinically tested in subjects with fatigue (chronic fatigue syndrome), post-traumatic stress disorder, convalescence and burnout. METHODS: One group of patients followed the standard management (SM) and was designated as control group while the supplementation group followed the SM and additionally took two Robuvit® capsules daily for six weeks (200 mg/day).The main study endpoints were the Karnofsky performance scale index, handgrip strength in kg, fitness test score on a treadmill, self-assessed work ability, fatigue score, oxidative stress and carcinoembryonic antigen (CEA) plasma levels. In addition, the mood of the patients was assessed using the 'brief mood introspection scale', BMIS. RESULTS: Fifty-one subjects with fatigue linked to convalescence within 1 month after chemotherapy for colon cancer completed the study, 29 in the Robuvit® group and 22 as controls. The two management groups were comparable for age and sex distribution. The main investigation parameters were also comparable at inclusion. No side effects or tolerability problems were observed in the six weeks of follow-up. Occasional use of painkillers, antinausea medication or anti-inflammatory agents was accepted. After six weeks, Robuvit® supplementation significantly improved the Karnofsky performance scale index compared to controls. Hand grip strength (dynamometry), treadmill fitness test score and the self-assessed work ability were significantly improved with Robuvit® as well. The fatigue score after six weeks was significantly improved with Robuvit® (P<0.05) in comparison with SM controls. Mood was significantly improved after 6 weeks in the Robuvit® patients compared to the control group. The examined study parameters improved in the patients of the control group as well, during a normal postchemotherapy convalescence, but in a lesser extend when compared to the supplementation group. Oxidative stress was high at inclusion in both groups. The decrease in oxidative stress - as plasma free radicals - was significantly higher with the supplementation (P<0.05). CEA values were within the normal values from inclusion and in the 6 weeks of the registry in all subjects. CONCLUSIONS: In conclusion, Robuvit® helps to reduce fatigue after chemotherapy and improves strength, performance, fitness, work ability and mood in these patients, without exposing them to the risk of side effects.

Intestinal fat absorption shifting with a polyglucosamine biopolymer slows down the progression of subclinical atherosclerosis: a pilot study.

BACKGROUND: Intestinal fat absorption shifting (IFAS) can be achieved with a polyglucosamine biopolymer (BP) able to retain most fats in the gut so that they are available to the intestinal microbiota (shift). The aim of this study was to evaluate the effects of the standard management (SM) of asymptomatic cardiovascular disease prevention on intima-media thickness (IMT) in comparison with SM combined with BP. METHODS: Two groups (SM and SM+3 g BP/day) were compared. They consisted of 86 and 81 subjects respectively treated for 6 months. Anthropometric variables, vital signs, fat mass, lipid profile, oxidative stress, carotid IMT, granulations at the IM layer and near-wall low density bubbles were measured. RESULTS: Seventy-eight cases in the SM group and 81 in the SM+BP group completed the management period. Compliance was optimal (>97%) with no side effects. The anthropometric variables, vital signs, fat mass and oxidative stress were significantly lower only in the SM+BP group (P<0.05). Cholesterol and triglyceride levels improved with BP use (P<0.05). The changes in IMT were reduced significantly (P<0.05) in the SM+BP group only. The same was true for intimal granulation/bubbles. CONCLUSIONS: The preliminary results suggest that the IFAS caused by BP has a positive effect on IMT and arterial wall structure (thickness and low-density bubbles) even during a short period of management. The intestinal fat shifting and reduction in oxidative stress seem to limit lipid oxidation and deposition on the arterial wall.

Pycnogenol®-Centellicum® supplementation improves lung fibrosis and post-COVID-19 lung healing.

BACKGROUND: The aim of this study was to evaluate the combination of Pycnogenol® (150 mg/day) (Horphag Research, London, UK) and Centella asiatica (Centellicum® 3×225 mg/day; Horphag Research) (PY-CE) for 8 months in subjects with sequelae of idiopathic interstitial pneumonia (IIP). Recently, post-COVID-19 lung disease is emerging with large numbers of patients left with chronic lung conditions. Considering the antifibrotic activity of the combination PY-CE, we also tested this supplementary management in post-COVID-19 lung patients. METHODS: Nineteen subjects with idiopathic interstitial pneumonia (IIP) were included in the study. High Resolution CT scans at inclusion confirmed the presence of lung fibrosis: 10 patients were treated with the Pycnogenol® Centellicum® combination and 9 subjects with standard management (SM) served as controls. Oxidative stress that was very high in all subjects at inclusion, decreased significantly in the supplement group (P<0.05). The Karnofsky Performance Scale Index significantly improved in the supplement group in comparison with controls (P<0.05). The symptoms (fatigue, muscular pain, dyspnea) were significantly lower after 8 months in supplemented patients (P<0.05) as compared with controls. RESULTS: At the end of the study, the small cystic lesions (honeycombing) and traction bronchiectasis were stable or in partial regression in 4 subjects in the supplemented group (vs. none in the control group) with a significant improvement in tissue edema in the supplemented subjects. On ultrasound lung scans the white (more echogenic) fibrotic component at inclusion was 18.5±2.2% in the images in controls vs. 19.4±2.7% in the supplement group. At the end of the study, there was no improvement in controls (18.9±2.5%) vs. a significant improvement in supplemented subjects (16.2±2.1%; P<0.05). In addition, 18 subjects with post-COVID-19 lung disease were included in the study; 10 patients were treated with the Pycnogenol® Centellicum® combination and evaluated after 4 weeks; 8 patients served as controls. Preliminary results show that symptoms associated with post-COVID-19 lung disease after 4 weeks were significantly improved with the supplement combination (P<0.05). Oxidative stress and the Karnofsky Performance Scale Index were significantly improved in the supplements group as compared with controls (P<0.05). CONCLUSIONS: According to these observations, Pycnogenol® controls and decreases edema and Centellicum® by modulating the apposition of collagen, slows down the development of irregular cicatrization, the keloidal scarring and fibrosis. More time is needed to evaluate this effect in a larger number of post-COVID-19 patients with lung disease. This disease has affected millions of subjects worldwide, leaving severe consequences. Pycnogenol® and Centellicum® may improve the residual clinical picture in post-COVID-19 lung disease (PCL) patients and may reduce the number of subjects evolving into lung fibrosis. The evolution from edema to fibrosis seems to be slower or attenuated with this supplement combination both in Idiopathic pulmonary fibrosis (IPF) and in PCL patients.

Restless legs syndrome: prevention with Pycnogenol® and improvement of the venoarteriolar response.

BACKGROUND: The aim of this registry study was to evaluate the preventive efficacy of Pycnogenol® (French maritime pine bark, standardized extract), an anti-inflammatory and antioxidant supplement, previously used for muscular pain and cramps, in otherwise healthy subjects with restless legs syndrome (RLS). METHODS: Two management groups were formed: one using the standard management (SM) and one using SM and Pycnogenol® 150 mg/day for 4 weeks. RESULTS: Forty-five subjects were included in the study, 21 took Pycnogenol® and 24 were in the SM group. After 4 weeks no side effects or tolerability problems were observed. Compliance was optimal. The two groups were comparable at baseline. Limb sensations were assessed with a Visual Analogue Scale Line (0 to 4). There was a statistically non-significant improvement with SM in all subjects. Improvement with Pycnogenol® supplementation was significant (P<0.05) for all assessed parameters with important clinical meanings as 19 out of 21 supplemented subjects reported a clear benefit from supplementation. Resting flux - slightly elevated at inclusion - was normalized in the supplemented group (P<0.05) as seen by a decrease in flux. The venoarteriolar response - affected at inclusion in all subjects with RLS - was improved with the supplement, indicating a better axon-axon reflex response and a lower level of subclinical neural alteration. The need for pain managements was significantly reduced (P<0.05) with supplementation after 4 weeks, as only 4/21 supplemented subjects vs. 16/24 in the SM-only group had to use analgesics. Thermography of the leg did not reveal any significant asymmetry of perfusion. Oxidative stress as plasma free radicals (PFR) was significantly improved (reduced) (P<0.05) in subjects using Pycnogenol®. Likewise, minimal edema, measured with the edema tester, was significantly decreased with Pycnogenol®. CONCLUSIONS: Pycnogenol® prevents or relieves symptoms associated with restless leg syndrome and positively affects the venoarteriolar response. Future studies in this condition, including more complex subjects may indicate the role of Pycnogenol® in this common and still obscure syndrome and in subclinical muscular and neurological alterations.

Prevention of work-related stress, fatigue, loss of cognitive function, improved attention and recovery of stamina with Robuvit® in professionals with increased oxidative stress.

BACKGROUND: The aim of this open, pilot supplement registry study was to evaluate the protective, preventive effects of Robuvit® on professional-related fatigue symptoms and on aspects of cognitive functions, professional attitudes and decision-making in healthy nurses under professional stress and with increased oxidative stress. METHODS: In total, 40 subjects, aged 30-37, completed the 4-week registry study. A control group of 20 subjects used only the standard management (SM) and one group of 20 subjects took 300 mg Robuvit® in addition. Safety and tolerability of Robuvit® were optimal. The two registry groups were comparable at inclusion. RESULTS: The overall scores of the real daily life and tasks questionnaire after 4 weeks were significantly higher in the Robuvit® group (P<0.05) as compared to controls. It increased from 4.3±0.4 at baseline to 6.78±0.8 after 4 weeks of Robuvit® intake and from 4.2±0.5 to 5.12±1.0 in the control group. The supplementation significantly improved the subjective perception of fatigue in comparison with controls (P<0.05). A practical professional score evaluation provided an indication of professional attitude and stamina, in difficult, stressful working conditions under continuous pressure. The results showed that after 4-week supplementation, all assessed parameters improved significantly and the difference with controls was statistically significant (P<0.05). Furthermore, oxidative stress as plasma free radicals decreased significantly in the Robuvit® group (P<0.05) but not in the control group. CONCLUSIONS: Robuvit® supplementation appears to improve most symptoms related to work-induced fatigue, stress and cognitive function and supports stamina. Further evaluations need to be planned according to the concept of this pilot registry in a field that requires more attention.

Preventive effects of Pycnogenol® on cardiovascular risk factors (including endothelial function) and microcirculation in subjects recovering from coronavirus disease 2019 (COVID-19).

BACKGROUND: The aim of this open supplement study was to evaluate the effects of Pycnogenol® in comparison with controls on symptoms of post-COVID-19 syndrome and in improving endothelial function, microcirculation, inflammatory markers and oxidative stress over 3 months in symptomatic subjects recovering from COVID-19. METHODS: Sixty subjects recovering from symptomatic COVID-19 were included. One group of 30 followed a standard recovery management while 30 comparable subjects received a supplement of 150 mg Pycnogenol® daily (in 3 doses of 50 mg) in addition to standard management. RESULTS: Two groups of selected subjects were comparable at baseline. The groups progressively improved both with the SM (standard management) and with the SM in combination with the supplement. Patients, supplemented with Pycnogenol® showed significantly better improvement compared to the control group patients. No side effects from the supplementation were observed; tolerability was optimal. The progressive evolution over time was visible in all target measurements. Physiological tests: endothelial function, low in all subjects at inclusion was assessed by flow mediated dilation (FMD) and finger reactive hyperemia in the microcirculation (laser Doppler measurements) after the release of an occluding suprasystolic cuff. It was significantly improved in the Pycnogenol® group after one month and after 3 months (P<0.05 vs. controls). The rate of ankle swelling (RAS) by strain gauge decreased significantly in the supplemented group (P<0.05) in comparison with controls showing an improvement of the capillary filtration rate. At inclusion, the kidney cortical flow velocity indicated a decrease in perfusion (lower systolic and diastolic flow velocity) in all patients. Kidney cortical flow velocity increased significantly with the supplement (P<0.05) in comparison with controls with improvement in systolic velocity and in diastolic component. High sensitivity CRP (hs-CRP) and Il-6 plasma levels decreased progressively over 3 months with a significant more pronounced decrease in the supplement group (P<0.05). The number of patients with normal plasma IL-6 levels at the end of the study was higher (P<0.05) with the supplement. ESR followed the same pattern with a progressive and a more significant decrease in the supplemented subjects (P<0.02). Oxidative stress decreased significantly in the supplemented group (P<0.05) compared with the control group. Systolic blood pressure was significantly lower in the supplemented group (P<0.05) at the end of the study. Finally, the scores of Quality-of-life, mood and fatigue questionnaire and the Karnofsky Scale Performance Index significantly improved in the supplement group (P<0.05) compared to controls after 1 and 3 months. All other blood parameters (including platelets and clotting factors) were within normal values at the end of the study. CONCLUSIONS: In conclusion, Pycnogenol® may offer a significant option for managing some of the signs and symptoms associated with post-COVID-19 syndrome. This pilot evaluation offers some potential rationale for the use of Pycnogenol® in this condition that will have significant importance in the coming years.