Effects of Ketone Monoester and Bicarbonate Co-Ingestion on Cycling Performance in WorldTour Cyclists.

The present randomized study investigated the effect of acute supplementation of 800 mg/kg of ketone monoester ingestion (KE) or placebo (PL) and 210 mg/kg of NaHCO3 co-ingestion on cycling performance of WorldTour cyclists during a road cycling stage simulation. Twenty-eight cyclists participated in the study (27.46 ± 4.32 years; 1.80 ± 0.06 m; 69.74 ± 6.36 kg). Performance, physiological, biochemical, and metabolism outcomes, gut discomfort, and effort perceived were assessed during a road cycling simulation composed of an 8-min time-trial (TT) performance + 30-s TT + 4.5 hr of outdoor cycling + a second 8-min TT + a second 30-s TT. Greater absolute and relative mean power during the first 8-min TT (F = 5.067, p = .033, ηp2=.163, F = 5.339, p = .029, ηp2=.170, respectively) was observed after KE than after PL (KE: 389 ± 34, PL: 378 ± 44 W, p = .002, d = 0.294 and KE: 5.60 ± 0.42, PL: 5.41 ± 0.44 W/kg, p = .001, d = 0.442). Additionally, greater concentration of ß-hydroxybutyrate blood concentration (F = 42.195, p < .001, ηp2=.619) was observed after KE than after PL during the first steps of the stage (e.g., after warm-up KE: 1.223 ± 0.642, PL: 0.044 ± 0.058 mM, p < .001, d = 2.589), although the concentrations returned to near baseline after 4.5 hr of outdoor cycling. Moreover, higher values of anion gap were observed (F = 2.333, p = .026, ηp2=.080) after KE than after PL ingestion, after the warm-up and after the first 8-min and 30-s TT. Additionally, lower concentrations of HCO3- were reported in the KE condition after warm-up and after the first 8-min and 30-s TT. During the initial phase of the stage simulation, acute supplementation with KE + NaHCO3 co-ingestion enhanced 8-min TT cycling performance (3.1%) in WorldTour cyclists with a concomitant hyperketonaemia.

Effectiveness of a polyphenolic extract (Lippia citriodora and Hibiscus sabdariffa) on appetite regulation in overweight and obese grade I population: an 8-week randomized, double-blind, cross-over, placebo-controlled trial.

INTRODUCTION: Polyphenols have shown capacity to improve appetite sensation, leading to enhanced control of body weight. However, despite being related with hunger-related hormones, metabolic and mechanism are not well known. METHODS: The effectiveness of a nutraceutical composed of extract to Lippia citriodora and Hibiscus sabdarrifa (Lc-Hs) for controlling satiety and hunger was analyzed in a cross-over, placebo-controlled (Pla) clinical intervention. The study was divided in two 60-day periods separated by 30-day length wash-out period. At the end of each period, overweight and obese subjects (n = 33; age = 33.76 ± 12.23; BMI = 28.20 kg/m2 ± 2.47; fat mass 30.65 ± 8.39%; both sexes were proposed to eat an ad-libitum meal. Meanwhile, appetite sensation was determined by visual analog scales at different times. Moreover, blood extraction was performed to determine biochemical parameters (lipid and glucidic profile and safety parameters) and to evaluate hunger-related hormones (insulin, leptin, ghrelin, adiponectin, GLP-1 and peptide YY). RESULTS: A decrease in appetite sensation was observed in Lc-Hs treatment, showing higher satiety quotient (Pla = 3.36 ± 2.33%mm/kcal; Lc-Hs = 5.53 ± 2.91%mm/kcal; p < 0.0001). Area under the curve was higher in Pla compared to Lc-Hs during the test, from baseline to minute 240 (240 (Pla 9136.65 ± 2261.46% x min-1; Lc-Hs 8279.73 ± 2745.71% x min-1; p < 0.014). Energy consumption was lower for subjects treated with Lc-Hs (774.44 ± 247.77 kcal) compared to those treated with Pla (849.52 ± 246.54 kcal) (p < 0.004). Leptin values varied from baseline (Pla 12.36 ± 1.98 ng/mL; Lc-Hs 13.13 ± 1.99 ng/mL) to the end of the study (Pla 12.60 ± 2.02 ng/mL; Lc-Hs 12.06 ± 2.05 ng/mL; p < 0.047). GLP-1 values varied (p < 0.001) in Lc-Hs treatment from baseline (4.34 ± 0.49 ng/mL) to the end of the study (3.23 ± 0.52 ng/mL). CONCLUSION: The supplementation with the Lc-Hs extract decreases appetite sensation in overweight and obese population, reducing calorie intake after an ad-libitum meal. Due to variation on hunger-related hormones and the relationship between satiety feeling, it would be interesting to develop future research focused on the variation of the hormones themselves.

Tolerability of Oral Supplementation with Microencapsulated Ferric Saccharate Compared to Ferrous Sulphate in Healthy Premenopausal Woman: A Crossover, Randomized, Double-Blind Clinical Trial.

A single-center, crossover, randomized, double-blind, and controlled clinical study was conducted to assess the tolerability profile, especially with regard to gastrointestinal complaints, of oral supplementation with AB-Fortis®, a microencapsulated ferric saccharate (MFS), as compared with conventional ferrous sulphate (FS) in healthy premenopausal women. A dose of 60 mg/day of elemental iron was used. The test products were administered for 14 consecutive days with a washout period of two menstrual episodes and a minimum of one month between the two intervention periods. The subjects completed simple-to-answer questionnaires daily for 14 days during both the intervention and the washout periods, capturing the symptoms associated with oral iron supplementation and overall health aspects. Following product consumption, the incidences of symptoms, numbers of complaints/symptoms, overall intensity, and total days with symptoms were found to be significantly higher for FS consumption as compared to MFS. The better tolerability profile of MFS over FS was further substantiated when both products were compared to a real-life setting (i.e., the washout period). Overall, the administration of both study products was safe with no serious or significant adverse events reported. In summary, the current study shows the better tolerability of the MFS preparation when compared to that of the FS, presenting MFS as a well-tolerated and safe option for improving iron nutrition.

A Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Effectiveness of a Polyphenolic Extract (Hibiscus sabdariffa and Lippia citriodora) for Reducing Blood Pressure in Prehypertensive and Type 1 Hypertensive Subjects.

Hypertension is an important factor of cardiovascular diseases and contributes to their negative consequences including mortality. The World Health Organization estimated that 54% of strokes and 47% of cases of ischemic heart illness are related to high blood pressure. Recently, Hibiscus sabdariffa (HS) and Lippia citriodora (LC) have attracted scientific interest, and they are recognized for their high content of polyphenols as these may prevent several disease factors, such as hypertension. The aim of the present study is to determine if supplementation with an HS-LC blend (MetabolAid®) may be effective for the treatment of type 1 hypertensive sedentary populations. A total of 80 type 1 hypertensive subjects of both sexes were included in the study and were treated with placebo or the HS-LC extract, and both groups were treated over 84 days. The blood pressure (diastolic, systolic, and pulse pressure) was measured throughout the day, for each of the days of the study duration and determined using Ambulatory Blood Pressure Monitoring (ABPM). Physical activity was determined throughout the study to ensure similar conditions related to exercise. The results showed the capacity for reducing the blood pressure parameters in the case of the HS-LC extract. The daily consumption of the HS-LC extract but not the placebo over 84 days was able to reduce the daytime parameters related to blood pressure. The most remarkable results were observed in the measurements performed during the daytime, especially in the systolic blood pressure showing statistically significant variation.

Dietary supplementation with a wild green oat extract (Avena sativa L.) to improve wellness and wellbeing during smoking reduction or cessation: a randomized double-blind controlled study.

Objective: Smoking reduction or cessation are critical public health goals, given the well-documented risks of tobacco use to health. Reducing smoking frequency and cessation entirely are challenging due to nicotine addiction and withdrawal symptoms, which can significantly affect mental wellness and overall wellbeing. Previous research has suggested that certain dietary supplements may support smoking cessation and reduction efforts by mitigating these adverse effects. The objective of this study was to assess the effect of supplementation with 900 mg/day of Neuravena®, a green oat extract (GOE) of Avena sativa L., in enhancing wellness and wellbeing during a smoking reduction or cessation experience. Methods: This was an 8-week randomized, double-blind, placebo-controlled study, ClinicalTrials Identifier: NCT04749017 (https://classic.clinicaltrials.gov/ct2/show/NCT04749017). Participants were assigned to one of the study groups, 72 participants were assigned to GOE and 73 to placebo. The subjects were followed for 8-weeks intervention period as well as an additional 4-week follow-up period. At subsequent visits, they underwent clinical assessments including assessments of quality of life, perceived stress, depression, nicotine dependence, anxiety, cognitive performance, and specific assessments of craving intensity. Results: GOE was associated with greater improvements in elements of the abbreviated World Health Organization Quality of Life (WHOQOL-BREF) questionnaire as compared with placebo. Similar results were obtained from the SF-36 questionnaire and a visual QoL analogue scale (VAS). Perceived stress levels showed greater decline from baseline among the GOE supplemented participants as compared to placebo. Sleep quality parameters improved with GOE supplementation and worsened in the placebo group. At the end of the intervention period, the percentage of successful reducers (defined as >20% reduction in daily cigarettes) was higher in the GOE group as compared to placebo (66.7% vs. 49.3%, p = 0.034). The improvements from baseline in QoL measures in the GOE group persisted at 4 weeks after termination of the intervention. Conclusion: GOE supplementation demonstrated greater improvements in quality of life measures, stress and sleep related parameters during a smoking reduction or cessation experience and the product was shown to be safe and well tolerated.

Dietary Supplementation with an Extract of Aloysia citrodora (Lemon verbena) Improves Sleep Quality in Healthy Subjects: A Randomized Double-Blind Controlled Study.

Seventy-one healthy subjects with sleep disturbances participated in a randomized, double-blind controlled trial in which dietary supplementation with an extract of Aloysia citrodora (lemon verbena) (n = 33) or placebo (n = 38) was administered for 90 days. There were between-group differences in favor of the experimental group in the visual analogue scale (VAS) for sleep quality (6.5 ± 1.6 vs. 5.5 ± 2.1, p = 0.021) as well as in the overall score (5.8 ± 2.4, p = 0.008) and scores for sleep latency (1.6 ± 1.0 vs. 1.9 ± 0.7, p = 0.027) and sleep efficiency (84.5 ± 12.8 vs. 79.8 ± 13.6, p = 0.023) in the Pittsburgh Sleep Quality Index (PSQI). Sleep-related variables (latency, efficiency, wakefulness after sleep onset, awakenings) assessed by actigraphy also showed better scores in the experimental group (p = 0.001). Plasma nocturnal melatonin levels also increased significantly in the experimental group (199.7 ± 135.3 vs. 174.7 ± 115.4 pg/mL, p = 0.048). Changes in anthropometric parameters and physical activity levels were not found. In summary, a dietary supplement of lemon verbena administered for 3 months was associated with a significant improvement in sleep quality as compared with placebo in a population of healthy subjects with sleep problems.

Dietary supplementation with plant extracts for amelioration of persistent myofascial discomfort in the cervical and back regions: a randomized double-blind controlled study.

Background: Back pain is a common health problem that affects both workers and older people, reducing their quality of life. The primary objective was to assess the effect of dietary supplementation with plant extracts of rosemary, ashwagandha, and sesame consumed for 12 weeks on the intensity of back pain. Methods: A single-center randomized double-blind study with three parallel arms depending on the product consumed. The duration of treatment was 12 weeks. The investigational product, Berelief®, contained a blend of three polyphenolic standardized extracts: rosemary (Rosmarinus officinalis L.), ashwagandha (Withania somnifera L.), and sesame (Sesamum indicum L.) seed. Two doses were tested: low dose (400 mg) and high dose (800 mg). There were 42 subjects in the placebo group, 39 in the low dose and 42 in the high dose groups. Study variables included back pain intensity [VAS score, Patient-Reported Outcomes Measurement Information System (PROMIS-29), and Cornell Musculoskeletal Discomfort Questionnaire; functionality Roland-Morris Disability (RMD) questionnaire]; quality of life (QoL) [36-item Short Form Survey (SF-36), the Beck Depression Inventory-II (BDI-II), the State-Trait Anxiety Inventory (STAI), and the Perceived Stress Scale (PSS)]; sleep quality [accelerometer and Pittsburgh Sleep Quality Index (PSQI)]. Results: The improvement in back pain recorded by the visual analogue scale (VAS) at the study visits after the beginning of treatment, as well as on a weekly basis recorded in the diary card was significantly higher in the intervention group than in the placebo group (p < 0.044 dose-low; p < 0.005 dose-high). Significant differences in pain intensity of the PROMIS-29 (p = 0.002) and upper back pain in the Cornell questionnaire (p = 0.011) in favour of the investigational product were found. Furthermore, benefits in improving health-related quality of life, mood and sleep quality were also detected. Conclusion: Dietary supplementation for 12 weeks of a blend of polyphenolic standardized extracts of rosemary, ashwagandha, and sesame was effective in reducing the intensity of pain in subjects with chronic myofascial cervical and back pain.

Efficacy of Boswellia serrata Extract and/or an Omega-3-Based Product for Improving Pain and Function in People Older Than 40 Years with Persistent Knee Pain: A Randomized Double-Blind Controlled Clinical Trial.

A single-center, randomized, double-blind, controlled clinical trial with four arms was conducted in healthy subjects with persistent knee discomfort (pain intensity on 1-10 cm visual analog scale (VAS) > 3) aged 40 years and older treated with a dietary supplement for 8 weeks. The study groups were Boswellia serrata extract (n = 29), an omega-3-based product (AvailOm® 50 High EPA) (n = 31), Boswellia + AvailOm® (n = 30), and placebo (n = 30). The intake of Boswellia + AvailOm® improved the quality of life (QoL) (WOMAC index) and some variables of muscle strength. Statistically significant differences between the AvailOm® and the placebo groups in the decrease of pain intensity were found. Weekly VAS scores showed a significant decrease in pain perception when comparing the AvailOm® product to the placebo, with the lowest VAS scores at week 8. Consumption of Boswellia improved sleep latency. The time to perform the Up and Go test decreased after the intake of AvailOm®. There was an increase in the omega-3 fatty acids, with the greatest increase in the Boswellia + AvailOm® group. AvailOm® was safe and effective in reducing pain and improving the QoL and functionality of subjects over 40 years with persistent knee pain.

Effect of a sustained-release formulation of ß-alanine on laboratory parameters and paresthesia in recreational trained men: a randomized double-blind placebo-controlled study.

Introduction: Beta-alanine is a non-essential amino acid that has been a focus of increasing research by its role as ergogenic aid to improve muscle performance. Methods: A randomized, double-blind and controlled trial was conducted to determine the effect of a nutritional supplement of a sustained-release formulation of ß-alanine in recreational trained men. The active product was an innovative sustained-release ß-alanine microgranules powder blend, administered at high doses (15 g/day) divided into 3 intakes during 30 days. There were 10 participants in the experimental group and 9 in the placebo group, with a mean age of 22.5 ± 3.3 years. Participants were testing at baseline and at the end of study. Results: In the ß-alanine group, there were statistically increases in serum triglycerides, LDL-cholesterol, and urea nitrogen at the end of the study as compared with baseline, although there were no differences with the control group. The occurrence of paresthesia, described above all as tickling, was the majority but presented VAS score less than 3/10 in almost all subjects. Discussion: More studies are required to evaluate the changes in blood parameters that can be caused by high intake of ß-alanine during a long period of time. Clinical trial registration: ClinicalTrials.gov, identifier (NCT05334121).

Randomised Clinical Trial to Analyse the Efficacy of Eggshell Membrane to Improve Joint Functionality in Knee Osteoarthritis.

Osteoarthritis is a source of chronic pain and disability. Dietary supplements have been shown to be a more secure option than NSAIDS. Particularly, the eggshell membrane has demonstrated efficacy in relieving joint pain and stiffness. A clinical trial was designed in which three groups were assigned to two different doses of this supplement and compared to a placebo control group. The primary outcome variable was knee pain, which was assessed using a visual analogue scale. Secondary outcome variables were knee functional ability, quadriceps muscle strength (assessed by isometric and isokinetic trials), and quality of sleep. All groups showed a significant decrease in pain perception, although maximum values were obtained in the high-dose group. Isokinetic and isometric trials showed a significant increase in strength in the high-dose group. Eggshell membrane showed the potential to reduce pain and stiffness symptomatology. Here, for the first time, two quantitative variables (mobility and strength of knee joint) were used to accurately evaluate changes in the quality of life of subjects affected by knee joint pain. The results of this study indicate a dose-dependent response, which should be taken into account for later use in therapeutics to establish the correct dosage.

Dry Needling Alone or in Combination with Exercise Therapy versus Other Interventions for Reducing Pain and Disability in Subacromial Pain Syndrome: A Systematic Review and Meta-Analysis.

This systematic review and meta-analysis examined the effects of dry needling alone or in combination with exercise therapy for reducing pain and disability in people with subacromial pain syndrome. Systematic searches of randomized clinical trials (RCTs) were performed in five different databases. A meta-analysis was carried out with the data obtained, and the risk of bias and quality of the studies was assessed using the Cochrane ROB 2.0 and GRADE tools. Finally, five RCTs (n = 315) were included in the meta-analysis and qualitative analysis. Our results determine that dry needling alone or combined with exercise therapy showed improvements in pain in the short-term (5RCTs: SMD: -0.27; [-0.49, -0.05]; low-quality) and mid-term (4RCTs: SMD: -0.27; [-0.51, -0.04]; low-quality) compared to a range of interventions. However, no differences were shown for disability at short-term (3 RCTs: SMD: -0.97; [-2.04, 0.11]; very-low quality) and mid-term (3 RCTs: SMD: -0.85; [-1.74, 0.04]; very-low quality). Dry needling alone or in combination with exercise therapy may result in a slight reduction in pain in the short-term and mid-term. However, the evidence about the effect of this therapy on disability in the short- or mid-term is very uncertain compared to the range of interventions analyzed in this systematic review (Registration: INPLASY202260112).

Acute Effects of Surgical and FFP2 Face Masks on Physiological Responses and Strength Performance in Persons with Sarcopenia.

Due to COVID-19, wearing a face mask to reduce virus transmission is currently mandatory in some countries when participants practice exercise in sports centers. Therefore, the aim of the present study was to analyze the effect of wearing a surgical or FFP2 mask during a resistance training session. Fourteen people with sarcopenia (age: 59.40 ± 5.46 years; weight: 68.78 ± 8.31 kg; height: 163.84 ± 9.08 cm) that participated in the study performed three training sessions in a randomized order: 4 sets of 10 repetitions of a half-squat at 60% of the one-repetition maximum and 90 s of rest between set and were either (a) without a mask (NM), (b) wearing a surgical face mask (SM), and (c) wearing a FFP2 face mask (FFP2). We found that wearing face masks had no effect on strength performance (session mean propulsive velocity (m/s): WM: 0.396 ± 0.042; SM: 0.387 ± 0.037; and FFP2: 0.391 ± 0.042 (p = 0.918)). Additionally, no impact of wearing a mask was found on heart rate, heart rate variability, blood lactate concentration (WM: 4.17 ± 1.89; SM: 4.49 ± 2.07; and FFP2: 5.28 ± 2.45 mmol/L (p = 0.447)), or rating of perceived exertion. Wearing a surgical or FFP2 face mask during a resistance training session resulted in similar strength performance and physiological responses than the same exercise without a mask in persons with sarcopenia.

A 12-Week Randomized Double-Blind Placebo-Controlled Clinical Trial, Evaluating the Effect of Supplementation with a Spinach Extract on Skeletal Muscle Fitness in Adults Older Than 50 Years of Age.

The aim of a 12-week randomized double-blind placebo-controlled study was to assess the effect of daily supplementation with a natural extract of Spinacia oleracea L. (4 × 500 mg capsules/day; total 2 g per day) combined with a moderate-intensity training program (1 h session/3 times a week) on skeletal muscle fitness in adults over 50 years of age. Muscle strength assessed by isokinetic and isometric dynamometry improved significantly in the experimental (n = 23) and the placebo (n = 22) groups, but the magnitude of improvement was higher in the experimental group, with between-group differences in almost all variables, including isokinetic at 60° s-1 in knee extension, peak torque (p < 0.007); total work per repetition maximum (p < 0.009); isokinetic at 180°s-1 in knee extension, peak torque (p < 0.002); total work (p < 0.007); total work per repetition maximum (p < 0.005); average power (p < 0.027); isometric in knee extension, peak torque (p < 0.005); and average peak torque (p < 0.002). Similar findings were observed for muscle quality. Changes in quality of life (SF-36) were not found, except for improvements in the role physical (p < 0.023) and role emotional (p < 0.001) domains, likely as a result of the physical training sessions. A nutritional survey did not revealed changes in dietary habits. No adverse events were recorded. In subjects over 50 years of age, moderate-intensity strength training combined with daily supplementation for 12 weeks with a natural extract of Spinacia oleracea L. improved muscle-related variables and muscle quality. Maintaining muscle health is a key component of healthy aging.

Increased Bioavailability of ß-Alanine by a Novel Controlled-Release Powder Blend Compared to a Slow-Release Tablet.

BACKGROUND: ß-Alanine is a sport supplement with increasing popularity due to its consistent ability to improve physical performance, with the downside of requiring several weeks of supplementation as imposed to the maximum daily and single dose tolerated without side effects (i.e., paresthesia). To date, the only alternative to overcome this problem has been use of a sustained-release tablet, while powders are the most commonly used format to deliver several grams of amino acids in a single dose. In this study we assessed the bioavailability, pharmacokinetics and paresthesia effect of ß-alanine after administration in a novel controlled-released powder blend (test) versus a sustained-release tablet (reference). METHODS: Twelve subjects (25.6 ± 3.2 y, 50% female) participated in a randomized, single-blind, crossover study. Each participant was administered orally the test (ß-alanine 8 g, l-histidine 300 mg, carnosine 100 mg) or the reference product (10 tablets to reach ß-alanine 8 g, Zinc 20 mg) with a 1-week washout period. ß-Alanine plasma concentrations (0-8 h) were determined by LC-MS/MS and model-independent pharmacokinetic analysis was carried out. Paresthesia intensity was evaluated using a Visual Analog Score (VAS) and the categorical Intensity Sensory Score (ISS). RESULTS: The CMAX and AUC0→∞ increased 1.6- and 2.1-fold (both p < 0.001) in the test product, respectively, which yielded 2.1-fold higher bioavailability; Ka decreased in the test (0.0199 ± 0.0107 min-1) versus the reference (0.0299 ± 0.0121 min-1) product (p = 0.0834) as well as V/F and Cl/F (both p < 0.001); MRT0→last increased in the test (143 ± 19 min) versus reference (128 ± 16 min) formulation (p = 0.0449); t1/2 remained similar (test: 63.5 ± 8.7 min, reference: 68.9 ± 9.8 min). Paresthesia EMAX increased 1.7-fold using the VAS (p = 0.086) and the ISS (p = 0.009). AUEC increased 1.9-fold with the VAS (p = 0.107) and the ISS (p = 0.019) reflecting scale intrinsic differences. Pharmacokinetic-pharmacodynamic analysis showed a clockwise hysteresis loop without prediction ability between CMAX, AUC0→∞ and EMAX or AUEC. No side effects were reported (except paresthesia). CONCLUSIONS: The novel controlled-release powder blend shows 100% higher bioavailability of ß-alanine, opening a new paradigm that shifts from chronic to short or mid-term supplementation strategies to increase carnosine stores in sports nutrition.

One-Week High-Dose ß-Alanine Loading Improves World Tour Cyclists' Time-Trial Performance.

Supplementation with ß-alanine is becoming a common practice in high-performance athletes. The purpose of the present study was to investigate the effects of a one-week high-dose ß-alanine loading phase employing a sustained-release powder on preserving the time-trial performance capacity of world tour cyclists during overreaching training. Per day, 20 g of sustained-release ß-alanine was administered during one week (7 days) of intensive team training camp in a randomised balanced placebo-controlled parallel trial design, with six participants in each ß-alanine (BA) or placebo (PLA) group. A 10-min time trial (10' TT) was carried out to analyse performance and biochemical variables. Anthropometry, paresthesia, and adverse event data were also collected. Power-based relative training load was quantified. Compared to placebo, the BA improved mean power (6.21%, 37.23 W; 95% CI: 3.98-70.48 W, p = 0.046), distance travelled (2.16%, p = 0.046) and total work (4.85%, p = 0.046) without differences in cadence (p = 0.506) or RPE. Lactate (p = 0.036) and anion gap (p = 0.047) were also higher in the BA group, without differences in pH or Bicarbonate. High daily and single doses were well tolerated. One-week high-dose ß-alanine loading with a sustained-release powder blend can help attenuate 10' TT performance losses of world tour cyclists due to intensive training.

Effects of the Consumption of Low-Fat Cooked Ham with Reduced Salt Enriched with Antioxidants on the Improvement of Cardiovascular Health: A Randomized Clinical Trial.

The aim of the study was to analyze how cardiovascular risk factors can be modified using nutritionally improved cooked ham enriched with a pool of antioxidants to influence relevant metabolic targets. Sixty-five untreated subjects (49.2% males, 50.8% females, mean age 40.92 ± 9.03 years) with total cholesterol level ≥180 mg/dL or LDL cholesterol ≥130 mg/dL participated in a 8-weeks randomized, double-blind controlled trial. Participant in the intervention group (51.5% males, 48.5% females, mean age 41.6 ± 9.8 years and mean BMI 25.1 ± 3.6 kg/m2) consumed cooked ham enriched with antioxidants (100 g/d) and controls (49.9% males, 53.1% females, mean age 40.2 ± 8.3 years and mean BMI 26.3 ± 3.2 kg/m2) received placebo. At 8 weeks, oxidized LDL decreased significantly between experimental and placebo groups (p < 0.036). Experimental group differences were also significant (p < 0.05). Similar findings in malondialdehyde, total cholesterol, high-sensitivity C-reactive protein, and interleukin 6 were observed in the intervention group. Significant between-group differences in these variables were also found, except for total cholesterol and interleukin 6. The effects on inflammation and oxidation support the direct action of these antioxidants on the etiopathogenic factors of atheromatous plaque. We also observed an improvement in the lipid profiles among the subjects.

Effectiveness of Consumption of a Combination of Citrus Fruit Flavonoids and Olive Leaf Polyphenols to Reduce Oxidation of Low-Density Lipoprotein in Treatment-Naïve Cardiovascular Risk Subjects: A Randomized Double-Blind Controlled Study.

The aim of the study was to assess whether oral intake of a nutraceutical product (Citrolive™) could determine changes in low-density lipoprotein (LDL) oxidation and other parameters of lipid metabolism and plasma atherogenic capacity. Citrolive™ is a commercial extract obtained from the combination of citrus fruit flavonoids and olive leaf extracts. Twenty-three untreated subjects (69.6% males, 30.4% females, mean age 41.9 ± 9.4 years) with cardiovascular risk factors and a total cholesterol level >200 mg/dL and LDL cholesterol (LDL-C) > 130 mg/dL participated in a 3-month randomized double-blind controlled study. Participants in the intervention group (71.4% males, 28.6% females, mean age 42.7 ± 9.7 years) consumed Citrolive™ (500 mg, two capsules/day), and controls (66.7% males, 33.3% females, mean age 40.6 ± 9.4 years) received a matched placebo. At 3 months, oxidized LDL (ox-LDL) decreased significantly in the intervention group from 93.8 ± 19.1 U/L to 62.8 ± 28.7 U/L (p < 0.05), whereas the control group increased from 98.2 ± 23.5 U/L to 105.7 ± 21.9 U/L (p = 0.1). Between-group differences were also significant (p < 0.05). Similar findings in the ox-LDL/LDL-C ratio were observed. Serum paraoxonase activity (PON1) increased significantly in the intervention group from 64.5 ± 15.6 U/L to 78.7 ± 28.8 U/L (p < 0.05) but remained unchanged in controls. Consumption of Citrolive™ for 3 months in treatment-naïve subjects with moderate risk of atherosclerosis was associated with a reduction in oxidized LDL-C and LDL-oxidase/LDL-C ratio as compared to controls.

Antioxidant Effect of a Probiotic Product on a Model of Oxidative Stress Induced by High-Intensity and Duration Physical Exercise.

This randomized double-blind and controlled single-center clinical trial was designed to evaluate the effect of a 6-week intake of a probiotic product (1 capsule/day) vs. a placebo on an oxidative stress model of physical exercise (high intensity and duration) in male cyclists (probiotic group, n = 22; placebo, n = 21). This probiotic included three lyophilized strains (Bifidobacterium longum CECT 7347, Lactobacillus casei CECT 9104, and Lactobacillus rhamnosus CECT 8361). Study variables were urinary isoprostane, serum malondialdehyde (MDA), serum oxidized low-density lipoprotein (Ox-LDL), urinary 8-hydroxy-2'-deoxiguanosine (8-OHdG), serum protein carbonyl, serum glutathione peroxidase (GPx), and serum superoxide dismutase (SOD). At 6 weeks, as compared with baseline, significant differences in 8-OHdG (Δ mean difference -10.9 (95% CI -14.5 to -7.3); p < 0.001), MDA (Δ mean difference -207.6 (95% CI -349.1 to -66.1; p < 0.05), and Ox-LDL (Δ mean difference -122.5 (95% CI -240 to -4.5); p < 0.05) were found in the probiotic group only. Serum GPx did not increase in the probiotic group, whereas the mean difference was significant in the placebo group (477.8 (95% CI 112.5 to 843.2); p < 0.05). These findings suggest an antioxidant effect of this probiotic on underlying interacting oxidative stress mechanisms and their modulation in healthy subjects. The study was registered in ClinicalTrials.gov (NCT03798821).

Correction: Marhuenda, J., et al. A Randomized, Double-Blind, Placebo Controlled Trial to Determine the Effectiveness a Polyphenolic Extract (Hibiscus sabdariffa and Lippia citriodora) in the Reduction of Body Fat Mass in Healthy Subjects. Foods 2020, 9(1), 55.

The authors wish to make the following correction to this paper [...].

Effect of a Combination of Citrus Flavones and Flavanones and Olive Polyphenols for the Reduction of Cardiovascular Disease Risk: An Exploratory Randomized, Double-Blind, Placebo-Controlled Study in Healthy Subjects.

A single-center, randomized, double-blind controlled trial was conducted to assess the efficacy of a food supplement based on a combination of grapefruit, bitter orange, and olive extracts administered for eight weeks (n = 51) versus placebo (n = 45) on reduction of cardiovascular risk in healthy volunteers. Study variables included flow-mediated vasodilation (FMD), blood pressure (BP), lipid profile, thrombotic status, oxidative stress biomarkers, inflammation-related biomarkers, anthropometric variables, quality of life, and physical activity. The per-protocol data set was analyzed. In the active product group, there were statistically significant within-group differences at eight weeks as compared with baseline in FMD, systolic and diastolic BP, total cholesterol, LDL-C, LDL-oxidase, oxidized/reduced glutathione ratio, protein carbonyl, and IL-6. Significant between-group differences in these variables were also found. Significant changes in anthropometric variables and quality of life were not observed in the study groups. Changes in the level of physical activity were not recorded. Treatment with the active product was well tolerated. All these findings, taken together, support a beneficial effect of supplementation with a mixture of grapefruit, bitter orange fruits, and olive leaf extracts on underlying mechanisms that may interact each other to decrease the cardiovascular risk in healthy people.