Lack of Clinical Evidence Regarding the Guidelines for Vitamin B12 Deficiency: An Analysis From Literature and Recommendations From Clinical Practice.

BACKGROUND: Vitamin B12 deficiency is a critical medical condition that, if left untreated, can lead to severe symptoms and potentially serious and life-threatening complications. Clinical guidelines are designed to provide a standardized approach to diagnosis and treatment, aiming for consistency and effectiveness. However, it is well-established that not all patients fit into general guidelines. OBJECTIVE: To investigate the clinical relevance of the submitted research to support these protocols for diagnosing and treating a B12 deficiency. APPROACH: Conducting a literature review of the references focused and used on diagnosing and treating vitamin B12 deficiency in adults and children. RESULTS: No robust clinical trial nor RCT has been found to back up the current protocols. The research used is primarily based on assumptions rather than solid clinical evidence. CONCLUSION: Existing guidelines for vitamin B12 deficiency need to be significantly revised and improved through clinical research, clinical experience by experts in the field with input from patient groups worldwide.

Plain language titleAnalyzing the Lack of Research on Vitamin B12 Deficiency Guidelines: Insights from Studies and Clinical AdvicePlain language summaryThis study dives into Vitamin B12 deficiency, stressing its serious health impacts and potential life-threatening complications when not treated. The study aims to investigate the scientific articles supporting these guidelines and their clinical relevance, conducting an in-depth analysis of literature references. The manuscript investigates and criticizes current guidelines for B12 deficiency, pointing out 4 key issues reported by patients and clinicians worldwide. The results are grouped into 4 sections: Maintenance Dose Protocol: The study questions the adequacy of maintenance doses every few months, highlighting a lack of clinical evidence and challenging the idea of sufficient liver stores. Oral Supplementation Protocol: The effectiveness of oral supplements is questioned due to inconclusive trials, focusing on raising blood values rather than assessing actual clinical outcomes. Diagnosing B12 Deficiency in Children: Guidelines neglect B12 deficiency in children despite significant differences in B12 levels between adults and healthy kids, potentially leading to underdiagnosis and unnecessary suffering. Delay in Diagnosis and Treatment: Factors like a lack of awareness and diverse symptoms contribute to delays, emphasizing the ongoing challenge of standardizing B12 assays. In the discussion, the manuscript argues that awareness of guidelines is low, and evidence-based guidelines may lack practical relevance. It suggests a significant revision of guidelines based on robust clinical evidence, advocating for personalized treatment, patient monitoring tools, controlled trials, and age-related healthy levels. Recognizing diverse patient needs and implementing individualized therapies are crucial for improving care for those with vitamin B12 deficiency, emphasizing the importance of early recognition and intervention.

The role of diet and non-pharmacologic supplements in the treatment of chronic neuropathic pain: A systematic review.

BACKGROUND/IMPORTANCE: Dietary interventions, vitamins, and nutritional supplementation are playing an increasingly important role in the management of neuropathic pain. Current pharmacological treatments are poorly tolerated and ineffective in many cases. OBJECTIVE: This systematic review aims to study the efficacy of dietary interventions, vitamins, and nutritional supplementation in the management of chronic neuropathic pain in adults. EVIDENCE REVIEW: The review followed PRISMA guidelines and was registered with PROSPERO (#CRD42022300312). Ten databases and gray literature, including Embase.com, MEDLINE and Web of Science, were systematically searched using a combination of keywords and controlled vocabulary related to chronic neuropathic pain and oral non-pharmacological supplements. Studies on adult humans published between 2000 and 2021 were considered for inclusion. The Cochrane Handbook was used to assess risk of bias, and Grading of Recommendations Assessment, Development, and Evaluation was used to determine overall quality of evidence. FINDINGS: Forty studies were included in the final review, and results were categorized according to pain type including pain related to chemotherapy-induced peripheral neuropathy (CIPN, 22 studies, including 3 prospective cohorts), diabetic peripheral neuropathy (DPN, 13 studies, including 2 prospective), complex regional pain syndrome (CRPS-I, 3 studies, including 1 prospective), and other (2 studies, both RCT). The CIPN studies used various interventions including goshajinkigan (4 studies), vitamin E (5), vitamin B12 (3), glutamine (3), N-acetyl-cysteine (2), acetyl-l-carnitine (2), guilongtonluofang (1), ninjin'yoeito (1), alpha-lipoic acid (1), l-carnosine (1), magnesium and calcium (1), crocin (1), and antioxidants (1), with some studies involving multiple interventions. All CIPN studies involved varying cancers and/or chemotherapies, advising caution for generalizability of results. Interventions for DPN included alpha-lipoic acid (5 studies), vitamin B12 (3), acetyl-l-carnitine (3), vitamin E (1), vitamin D (2), and a low-fat plant-based diet (1). Vitamin C was studied to treat CRPS-I (3 studies, including 1 prospective). Magnesium (1) and St. John's wort (1) were studied for other or mixed neuropathologies. CONCLUSIONS: Based on the review, we cannot recommend any supplement use for the management of CIPN, although further research into N-acetyl-cysteine, l-carnosine, crocin, and magnesium is warranted. Acetyl-l-carnitine was found to be likely ineffective or harmful. Alpha-lipoic acid was not found effective. Studies with goshajinkigan, vitamin B12, vitamin E, and glutamine had conflicting results regarding efficacy, with one goshajinkigan study finding it harmful. Guilongtonluofang, ninjin'yoeito, and antioxidants showed various degrees of potential effectiveness. Regarding DPN, our review supports the use of alpha-lipoic acid, acetyl-l-carnitine, and vitamin D. The early use of vitamin C prophylaxis for the development of CRPS-I also seems promising. Further research is warranted to confirm these findings.

Effect of Lumenato a Tomato derived oral supplement on improving skin barrier strength.

INTRODUCTION: Improvement of skin barrier strength could lead to healthy and youthful appearance. "Beauty inside-out" approach using nutraceuticals such as tomato derived carotenoids to support skin barrier strength could be of benefit to the ageing population. METHOD: A panel of 60 female subjects were provided with the Lumenato capsules (containing carotenoids) or placebo capsules as nutritional supplements for 3 months. Skin health and barrier function were observed using evaporimeter which measures trans epidermal water loss (TEWL). Barrier strength was determined by study of the number of strippings required to disrupt skin barrier and barrier repair was observed in terms of TEWL a few hours after barrier disruption. Cutometer was used to observe skin firmness and elasticity. Measurements were obtained before treatment and after 4 and 12 weeks of use. RESULTS: Results indicated a statistically significant improvement (p < 0.05) in skin barrier strength; a higher number of strippings were required to disrupt skin barrier after 12 weeks of supplement use. There was also a significant improvement in skin firmness and elasticity as observed with a cutometer. CONCLUSION: Based on the confines and conditions of this study, oral supplementation with Lumenato resulted in significant improvement in skin barrier as well as skin firmness and elasticity.

Clinical Efficacy of Nutritional Supplements in Atopic Dermatitis: Systematic Review.

BACKGROUND: Atopic dermatitis (AD), also known as eczema, is a chronic inflammatory skin condition that presents with symptoms of intense pruritus, dryness, and erythema. Dissatisfaction with first-line therapies for AD, the desire to avoid steroids, and the extreme cost of effective biologics have created a demand for alternative treatment options such as oral vitamins and nutritional supplements. OBJECTIVE: The purpose of this review was to assess the effectiveness of oral nutritional supplements, pre- and probiotics, and vitamin deficiencies and supplements on AD symptomology and clinical course. METHODS: We searched Scopus, PubMed, and MEDLINE (Ovid interface) for English-language articles published between 1993 and 2023. The final search was conducted on June 22, 2023. The search terms comprised the following: "(Atopic Dermatitis or Atopic Eczema) AND (supplement OR vitamin OR mineral OR micronutrients OR Fish Oil OR Omega Fatty Acid OR Probiotics OR Prebiotics OR apple cider vinegar OR collagen OR herbal OR fiber)." RESULTS: A total of 18 studies-3 (17%) evaluating vitamins, 4 (22%) evaluating herbal medicine compounds, 2 (11%) evaluating single-ingredient nutritional supplements, and 9 (50%) evaluating pre- and probiotics-involving 881 patients were included in this review. CONCLUSIONS: Overall, there is weak evidence to support any one nutritional supplement intervention for the alleviation of AD symptoms. Multiple trials (4/18, 22%) showed promise for supplements such as Zemaphyte, kefir, and freeze-dried whey with Cuscuta campestris Yuncker extract. The most evidence was found on the effectiveness of probiotics on the clinical course of AD. Lactiplantibacillus plantarum, Ligilactobacillus salivarius, and Lactobacillus acidophilus specifically showed evidence of efficacy and safety across multiple studies (6/18, 33%). However, larger, more extensive randomized controlled trials are needed to determine the true effectiveness of these supplements on the broader population. TRIAL REGISTRATION: PROSPERO CRD42023470596; https://tinyurl.com/4a9477u7.

Beauty from within: Improvement of skin health and appearance with Lycomato a tomato-derived oral supplement.

BACKROUND: Healthy and a youthful appearance is a common desire of the aging population. "Beauty from within" involves using nutrition and nutraceuticals to support skin function for reducing and reversing signs of aging such as wrinkles, pigmentary changes, skin laxity, and dullness. Carotenoids possess strong antioxidant and anti-inflammatory activities and are effective in improving skin barrier and could thereby stimulate "beauty from within" by providing endogenous support to reduce the expressions of aging. AIM: This study was designed to determine whether 3-month supplementation with Lycomato would improve skin condition. METHOD: A panel of 50 female subjects used Lycomato capsules as nutritional supplements for 3 months. Skin status was observed via questionnaires for the assessment of skin condition and expert visual grading of facial markers such as wrinkles, tonality, roughness, laxity, and pore size. Skin barrier was assessed using transepidermal water loss (TEWL). Measurements were obtained before treatment and after 4 and 12 weeks of use. RESULTS: Results indicated a statistically significant improvement (p < 0.05) in skin barrier as measured by TEWL after 12 weeks of consuming the supplement. There was also a significant improvement in skin tonality, lines and wrinkles, pore size, and skin firmness as observed by expert evaluation as well as subject self-assessment. CONCLUSION: Based on the confines and conditions of this study, oral supplementation with Lycomato resulted in significant improvement in skin barrier. Visual appearance of lines and wrinkles, skin tonality, pores, smoothness, and firmness were considerably improved, and these improvements were found to be substantially discernible by the subjects.

Effects of l-Arginine Plus Vitamin C Supplementation on l-Arginine Metabolism in Adults with Long COVID: Secondary Analysis of a Randomized Clinical Trial.

Altered l-arginine metabolism has been described in patients with COVID-19 and has been associated with immune and vascular dysfunction. In the present investigation, we determined the serum concentrations of l-arginine, citrulline, ornithine, monomethyl-l-arginine (MMA), and symmetric and asymmetric dimethylarginine (SDMA, ADMA) in adults with long COVID at baseline and after 28-days of l-arginine plus vitamin C or placebo supplementation enrolled in a randomized clinical trial, compared with a group of adults without previous history of SARS-CoV-2-infection. l-arginine-derived markers of nitric oxide (NO) bioavailability (i.e., l-arginine/ADMA, l-arginine/citrulline+ornithine, and l-arginine/ornithine) were also assayed. Partial least squares discriminant analysis (PLS-DA) models were built to characterize systemic l-arginine metabolism and assess the effects of the supplementation. PLS-DA allowed discrimination of participants with long COVID from healthy controls with 80.2 ± 3.0% accuracy. Lower markers of NO bioavailability were found in participants with long COVID. After 28 days of l-arginine plus vitamin C supplementation, serum l-arginine concentrations and l-arginine/ADMA increased significantly compared with placebo. This supplement may therefore be proposed as a remedy to increase NO bioavailability in people with long COVID.

Effects of l-Arginine Plus Vitamin C Supplementation on Physical Performance, Endothelial Function, and Persistent Fatigue in Adults with Long COVID: A Single-Blind Randomized Controlled Trial.

Long COVID, a condition characterized by symptom and/or sign persistence following an acute COVID-19 episode, is associated with reduced physical performance and endothelial dysfunction. Supplementation of l-arginine may improve endothelial and muscle function by stimulating nitric oxide synthesis. A single-blind randomized, placebo-controlled trial was conducted in adults aged between 20 and 60 years with persistent fatigue attending a post-acute COVID-19 outpatient clinic. Participants were randomized 1:1 to receive twice-daily orally either a combination of 1.66 g l-arginine plus 500 mg liposomal vitamin C or a placebo for 28 days. The primary outcome was the distance walked on the 6 min walk test. Secondary outcomes were handgrip strength, flow-mediated dilation, and fatigue persistence. Fifty participants were randomized to receive either l-arginine plus vitamin C or a placebo. Forty-six participants (median (interquartile range) age 51 (14), 30 [65%] women), 23 per group, received the intervention to which they were allocated and completed the study. At 28 days, l-arginine plus vitamin C increased the 6 min walk distance (+30 (40.5) m; placebo: +0 (75) m, p = 0.001) and induced a greater improvement in handgrip strength (+3.4 (7.5) kg) compared with the placebo (+1 (6.6) kg, p = 0.03). The flow-mediated dilation was greater in the active group than in the placebo (14.3% (7.3) vs. 9.4% (5.8), p = 0.03). At 28 days, fatigue was reported by two participants in the active group (8.7%) and 21 in the placebo group (80.1%; p < 0.0001). l-arginine plus vitamin C supplementation improved walking performance, muscle strength, endothelial function, and fatigue in adults with long COVID. This supplement may, therefore, be considered to restore physical performance and relieve persistent symptoms in this patient population.

Residual gastric volume after 3 h of the ingestion of an oral supplement containing carbohydrates alone or associated with whey protein: a randomized crossover pilot study.

BACKGROUND: New formulas including a nitrogenous source to maltodextrin have been reported as preoperative beverages 2-3 h before anesthesia in the elective procedure. Whey protein is a potential candidate for the composition of this clear oral supplement. This study aimed to investigate the gastric residual volume (GRV) of healthy volunteers 3 h after the ingestion of an oral supplement containing carbohydrates (CHO) alone or combined with whey protein (WP). METHODS: This crossover clinical trial design includes young, healthy male volunteers with normal body mass index. Magnetic resonance imaging (MRI) scan of the upper abdomen to measure the GRV was performed in the participants in three phases: (1) after a fasting period of 8 h; (2) immediately after the ingestion of 200 mL of a clear supplement containing: (2a) 10 g of WP and 54 g of CHO (74% glucose and 26% maltodextrin)-WP + CHO group or (2b) 12.5% maltodextrin (25 g)-CHO group; and (3) after 3 h of the ingestion of both types of supplements. A week interval was programmed between phases 2a and 2b. RESULTS: There was no significant difference (p = 0.91; within-group comparison) of the mean ± SD of the GRV between phase 1 (WP + CHO: 23.45 ± 14.01; CHO: 25.03 ± 15.17 cm3; p = 0.78; between-groups comparison) and phase 3 (WP + CHO: 25.66 ± 9.31; CHO: 23.45 ± 13.58 cm3, p = 0.86; between-groups comparison). The GRV of phase 2 (WP + CHO: 206.43 ± 23; CHO: 203.99 ± 12.18 cm3; p = 0.82; between-groups comparison) was significantly greater (p < 0.01; within-group comparison) than both other two phases. CONCLUSION: The GRV after 3 h of the ingestion of either WP + CHO or CHO oral supplement returns to basal fast condition implying that gastric emptying after this interval of time is significantly completed. TRIAL REGISTRATION: Registered and posted on the ClinicalTrials.gov public website with Identifier: NCT05573854.

Use of Nutraceuticals in Elderly to Fight Inflammation and Immuno-Senescence: A Randomized Case-Control Study.

Elderly people are at high risk of suffering from infection and being affected by severe forms of disease because their immunosystem suffers from aging. The alteration of normal immune functions causes the increase of pro-inflammatory cytokines which can expose these people to increased risk of developing pathologies as cancer, diabetes, and/or arthritis. Some supplements could be helpful for restoring normal immune functions. We conducted a case-control study to evaluate the efficacy of a supplement containing Sambucus nigra, zinc, tyndallized Lactobacillus acidophilus (HA122), arabinogalactans, vitamin D, vitamin E, and vitamin C to improve the inflammatory levels (IL-6 and CRP) and to modulate the lymphocytes growth. Additionally, we analyzed wellness by self-questionnaire. This study had two control group: a young group and an elderly one. Our study showed that treating elderly patients with the supplement for 30 days improved IL-6, CRP, and lymphocytes levels; the result was independent from the dosage of the supplements used. Elderly patients, despite the improvement, were not able to reach the same conditions of young patients; however, most of the patients (>70%) claimed to "feel better" after the use of the supplement. The use of this supplement should be considered at a low dosage for a prolonged period to reduce inflammation and modulate immune senescence in patients over 60 years old.

A Systematic Review of Oral Nutritional Supplement and Wound Healing.

OBJECTIVE: To explore the current literature for effects of oral nutritional supplement on wound healing rates in humans. METHODS: A systematic review of the literature was performed using the Medline and PubMed database following PRISMA guidelines. The PubMed database was searched using terms relating to oral nutritional supplement and wound healing from 1837 to March 2020. Study inclusion criteria were: (i) design: randomized controlled trials, clinical studies, observational studies, clinical trials; (ii) population: adults; and (iii) intervention: oral nutritional supplement. RESULTS: The search yielded 2433 studies, 313 of which were clinical trials or clinical studies. After abstract review, 28 studies qualified to be included in the review evaluating the following supplementation categories on wound healing: protein and amino acids (10), mineral, vitamin and antioxidants (9), probiotics (1), and mixed nutrients (8). Arginine and omega-3 supplement were shown to improve wound healing in head and neck cancer patients with surgical wounds by decreasing incidence of postoperative complications and reducing length of hospital stay. Mineral, vitamins, and antioxidants enriched supplements were more beneficial in increasing wound healing than non-enriched protein supplement for diabetic foot and pressure ulcers. CONCLUSIONS: Supplementation of a variety of nutrients had variable effects on improving wound healing in different types of wounds. However, further research on the impact of nutritional supplements on surgical wound healing is necessary. The impact of multiple nutrient formulations may also need to be further evaluated for efficacy.

Role of perioperative nutritional status and enteral nutrition in predicting and preventing post-operative complications in patients with Crohn's disease.

Background: Perioperative immune-nutritional status is correlated with post-operative outcomes. This study aimed to evaluate whether pre-operative nutritional status could predict post-operative complications in patients with Crohn's disease (CD) and whether pre-operative enteral nutrition (EN) can prevent post-operative complications. Methods: This retrospective cohort study analyzed the electronic health records of 173 patients diagnosed with CD in Ruijin Hospital, Shanghai, China, between August 2015 and May 2021: 122 patients had pre-operative nutritional support while 51 patients underwent surgery without pre-operative nutritional support. The pre-operative nutritional status, disease activity index, disease-related data, frequency of multiple surgery, operative data, and post-operative characters in each group were compared to determine whether the nutritional support and status could significantly affect post-operative outcome. One-to-one propensity score matching (PSM) was performed to limit demographic inequalities between the two groups. Results: After PSM, no statistically significant differences were found in pre-operative patient basic characteristics between the two groups of 47 patients (98 patients in all) included in this study. Overall, 21 patients developed 26 post-operative complications. In terms of pre-operative nutritional status, the level of serum albumin (ALB), pre-albumin (pre-ALB), and hemoglobin (Hb) in the nutrition group were statistically higher than that in the control group. We also observed a statistically significant decrease in post-operative complications, need for emergency surgery, and staged operations, while the rate of laparoscopic surgery was higher in the nutrition group compared to the non-nutritional group. Post-operative complications were related to pre-operative nutritional condition, which indicated that EN may improve the nutritional status and reduced the rate of post-operative complications. Conclusion: Pre-operative nutritional status is correlated with post-operative outcomes while EN plays a positive role in preventing the post-operative complications. EN is useful for improving the pre-operative nutritional status and reducing the post-operative adverse events for CD patients undergoing surgery.

Vitamin D3 and B12 supplementation in pregnancy.

AIM: To assess the efficacy of vitamin D3 or B12 supplementation during pregnancy. METHODS: Pregnant women at 6-14 weeks in the intervention arm received oral high dose intermittent vitamin D3 and/or low dose B12 supplementation if they had vitamin D or vitamin B12 deficiency. The control arm received prescribed dietary instruction only. An additional observational arm for those mothers at booking with normal vitamin D and vitamin B12 level was also recruited. All groups received standard care during pregnancy. RESULTS: The primary endpoint of either vitamin D or B12 at term was not met. At baseline 25% participants in both the interventional and control arms had severe D deficiency (<30 nmol/l), reducing to under 3.4% in both groups. No maternal differences in vitamin D or B12 levels were found at delivery between the intervention, control, or observational groups. No significant difference in any of the pregnancy or birth outcomes was observed between three groups. CONCLUSIONS: In this study, oral supplementation of high dose intermittent vitamin D or low dose vitamin B12 regime failed to correct the relevant nutritional deficiencies in Bangladeshi pregnant women as per protocol. Both dietary supplementation and high dose vitamin D corrected severe vitamin deficiency.

Difensil Immuno Reduces Recurrence and Severity of Tonsillitis in Children: A Randomized Controlled Trial.

Oral supplements (OS) support the immune system in fighting upper airways infection. This study aimed to analyze the effect of Difensil Immuno (DI) on the recurrence of tonsillitis and fever in children. A multicentric randomized clinical trial was conducted. One-hundred and twenty children with chronic tonsillitis were randomly assigned to group A, B or control. Patients in group A were treated with 10 mL of DI for 90 consecutive days, patients in group B underwent treatment with 15 mL of DI for 45 consecutive days. The following data were collected at baseline (T0), T1 and T2: tonsillitis and fever episodes, tonsillar volume, blood test results. One-way ANOVA was used to analyze within and between variances. Patients in group A and B statistically improved their clinical parameters (episode of tonsillitis and fever, tonsillar volume) when compared to control group both at T1 and T2. However, T1 variances were more consistent in group A than in group B. All patients in the study groups improved their clinical outcomes. No statistically significant variances were observed in blood parameters both at T1 and T2. Our results suggest that children treated with DI had fewer episodes of tonsillitis and fever and a reduction in their tonsillar volume.

A Treatment Combination of Peels, Oral Antioxidants, and Topical Therapy for Refractory Melasma: A Report of 4 Cases.

BACKGROUND: Melasma is a difficult-to-treat, recurrent pigmentary disease. Combined therapy gives better, longer-lasting results. OBJECTIVE: To determine the clinical effects of a treatment protocol of trichloroacetic acid, phytic acid and ascorbic acid peel combined with oral antioxidant supplement and topical treatment for refractory melasma. PATIENTS AND METHODS: We present four cases of patients with melasma, who, despite multiple treatments including hydroquinone, showed no improvement. We initiated a 16-week protocol involving 3 in-clinic peels (4 weeks apart) and a daily home treatment. The peels contained 30% trichloroacetic acid, 2% phytic acid, 8% L-ascorbic acid, Camellia sinensis leaf extract and Vitis vinifera seed extract. The home treatment was a depigmenting serum (4-butyl resorcinol, hydroxy-phenoxy propionic acid and niacinamide), a specific SPF50+ sunscreen, and an oral supplement (Polypodium leucotomos; green tea extract; Vitis vinifera; vitamins C, E, and D; and carotenoids), all in the morning, and, at night, a compounded gel-cream (4% hydroquinone, 0.025% tretinoin and 1% hydrocortisone). After 16 weeks, the gel-cream was stopped; the rest of the regimen (topical and oral) was continued for 12 further weeks. Melasma was assessed using the melasma severity scale (MSS) before starting the protocol, and at 4 and 12 weeks after the last peel. Photographs were taken before treatment and at the last evaluation. Patients indicated their satisfaction on a 5-point scale. RESULTS: All patients had good tolerance to the procedures. Three showed an excellent (>75%) improvement and one showed a good (50-75%) improvement. All four were very satisfied. At follow-up (12 weeks after last peel), no patients had recurrence. CONCLUSION: This protocol of trichloroacetic acid, phytic acid and ascorbic acid peel combined with an oral supplement and topical daily treatment is a viable treatment option for refractory melasma.

Effect of oral supplements on the nutritional status of nasopharyngeal carcinoma patients undergoing concurrent chemotherapy: A randomized controlled Phase II trial.

OBJECTIVES: The objectives of this study were to prospectively compare individualized dietary counseling with or without oral nutritional supplements (ONSs) in nasopharyngeal carcinoma (NPC) patients undergoing concurrent chemoradiotherapy (CCRT) in a Phase II, randomized trial. MATERIALS AND METHODS: Between June 2014 and August 2016, Stage II-IVb NPC patients were randomly enrolled. The primary endpoint was change in body weight between during CCRT, and the secondary endpoints were change in body mass index (BMI) and fat-free mass index (FFMI). RESULTS: Fifty-two patients were randomized; 19 patients in the control group and 23 in the ONS group were eligible for analysis. Weight, BMI, and body composition parameters significantly decreased from baseline to week 6. FFMI was significantly better in patients with ONS intake >2/3 planed than the control group (P = 0.028). Weight and BMI maintenance was slightly better in patients with total intake >2/3 planed (P = 0.170 and P= 0.229, respectively). The mean Patient-Generated Subjective Global Assessment score was also better in the ONS group at the end of CCRT (P = 0.053). CONCLUSIONS: ONSs with individualized dietary counseling may be beneficial in patients with enough intake, and further prospective studies with large groups of patients are warranted.

Prospective Evaluation of the Efficacy of a Food Supplement in Increasing Photoprotection and Improving Selective Markers Related to Skin Photo-Ageing.

INTRODUCTION: Skin exposure to ultraviolet radiation (UVR) can cause oxidative stress, particularly in the absence of adequate protective measures or in individuals with a sensitive skin type. Most commonly, protection from UVR entails the use of topical sunscreens. Sunscreens, however, have various limitations. The objective of this study was to evaluate the efficacy and tolerability of an oral food supplement containing a combination of actives with mainly antioxidative properties (vitamins A, C, D3, E, selenium, lycopene, lutein, as well as green tea, polypodium and grape extracts) in the context of photoprotection. METHODS: Photoprotective efficacy was assessed in a 12-week-long, open, prospective and monocentric clinical study with 30 subjects (27 women and 3 men) having a Fitzpatrick skin type I-III and manifesting clinical ageing signs. The study included several visits (14, 28, 56, and 84 days after starting supplement intake), in which photoprotection was evaluated by the measurement of the minimal erythema dose (MED), while the antioxidant capacity of the skin was assessed through ferric reducing antioxidant power (FRAP) and malondialdehyde (MDA) assays. Additionally, several skin parameters (including radiance, elasticity, and moisture) were evaluated. Product evaluation was performed throughout the length of the study by means of a self-assessment questionnaire, and safety was monitored through a self-recording of all observed adverse reactions. RESULTS: The MED levels increased significantly compared to baseline throughout the study visits, reaching an increase of + 8.1% at T84, p < 0.001. FRAP results also indicated a significant increase in the antioxidant capacity of the skin compared to baseline (+ 22.7% at T84, p < 0.001), while the MDA assay showed a significant decrease in MDA concentration compared to baseline (- 6.4% at T84, p < 0.001) which, in line with the FRAP results, indicated enhanced antioxidative protection of the skin. All assessed skin parameters, including radiance (+ 36.1% at T84, p < 0.001), gross elasticity (+ 13.2% at T84, p < 0.001), net elasticity (+ 28.0% at T84, p < 0.001), and moisture (+ 13.8% at T84, p < 0.001) were also significantly improved. The product was well tolerated as no adverse events were attributed by the investigators to the use of the product. Additionally, the global score obtained from the self-assessment questionnaires provided overwhelmingly positive feedback from the study subjects. CONCLUSIONS: The food supplement evaluated in this study was effective and well-tolerated by the subjects, demonstrating a beneficial effect in terms of photoprotection, enhancing the antioxidative status of the skin and improving general skin condition. TRIAL REGISTRATION: Retrospectively registered 3rd October 2019, ISRCTN18121679.

[Nutritional management of elderly people, everyone's concern]. / Prise en charge diététique du sujet âgé, l'affaire de tous.

In order to provide the appropriate care with regard to nutrition and the fight against frailty, it is important to know how to analyse the physical and physiological capacities of the ageing population. These are assessed in relation to the measurement of the patient's muscle strength, walking speed and balance.

Beneficial Effects of Oral Supplementation With Ovoderm on Human Skin Physiology: Two Pilot Studies.

Collagens and hyaluronic acid have long been used in pharmaceuticals and food supplements for the improvement of skin elasticity and hydration. These compounds provide the building blocks of the skin. Ovoderm is an oral supplement obtained from eggshells that contains naturally occurring collagen and glycosaminoglycans, such as hyaluronic acid. We evaluated the efficacy of Ovoderm on skin biophysical parameters related to cutaneous aging such as elasticity, hydration, and pigmentation. Two pilot studies were run to assess the effect of daily oral supplementation with 300 mg Ovoderm on skin parameters. The first consisted of a self-assessment questionnaire intended to perform an assessment on skin, hair, and nail health after 50 days of treatment. The second measured the effect of 5-week treatment on hydration by corneometry, on elasticity with the cutometer, and on pigmentation with the mexameter. In the pilot study 1, participants were predominantly satisfied with the effects obtained on general face (100% volunteers satisfied) and body (94% volunteers satisfied) skin condition and skin properties (100% volunteers satisfied with facial skin softness, 94% with facial skin hydration, and 89% with body skin hydration) and partly with effects on hair (67% volunteers satisfied) and nail (50% volunteers satisfied) condition. The study 2 revealed a statistically significant improvement in skin elasticity (12% increase, p =.0136), a tendency to reduce skin pigmentation (5% decrease), and no significant change in skin hydration. Our study reflects that oral supplementation with Ovoderm is efficacious to reduce the gradual loss of skin elasticity characteristic of aged skin, which helps to improve the appearance of the skin.

Clinical effects of an oral supplement rich in antioxidants on skin radiance in women.

BACKGROUND: Environmental factors impact the skin aging resulting in decrease of skin radiance. Nutrition and particularly antioxidants could help to fight against skin degradation. OBJECTIVE: The aim of this study was to evaluate the effects of an oral supplement rich in specific antioxidants, SkinAx2TM, on the improvement of the skin radiance in women. METHODS: The open-label clinical study enrolled 35 women, aged 40-70, with facial dull complexion. Subjects were supplemented orally with a daily dosage of 150 mg of an antioxidant-rich formulation containing superoxide dismutase-rich melon concentrate, grape seed extract rich in monomers of flavanols, vitamin C, and zinc for 8 weeks. Each subject served as her own control. The C.L.B.T.™ test has been used to evaluate facial skin coloring (C), luminosity (L), brightness (B), and transparency (T) involved in skin radiance. Facial skin imperfections have been assessed by clinical assessment. Firmness has been evaluated by clinical assessment and cutometer measurement. Finally, an auto-questionnaire has been carried out in order to evaluate the satisfaction of the subjects concerning different parameters involved in skin radiance and the global efficacy of the supplement. RESULTS: Skin "red pink" and "olive" colors were significantly improved after supplementation (P<0.0001). Luminosity was increased by 25.9% (P<0.0001) whereas brightness and transparency were not affected by the supplementation. Facial skin imperfections were significantly reduced after the antioxidant-rich formulation intake (global reduction: -18.0%; P<0.0001). Indeed, dark circles, redness, and spots significantly diminished after oral treatment. Firmness and elasticity have been shown to be improved. Subjects were globally satisfied by the product (82.4%) and have found improvements on their facial skin. Furthermore, 64.7% reported to look better at the end of the supplementation. CONCLUSION: The oral supplement containing the antioxidant-rich formulation was found to improve skin radiance by reducing skin coloring, increasing face luminosity, reducing imperfections, and improving skin firmness in women with dull complexion.

Supplementation of Reduced Gluten Barley Diet with Oral Prolyl Endopeptidase Effectively Abrogates Enteropathy-Associated Changes in Gluten-Sensitive Macaques.

Celiac disease (CD) is an autoimmune disorder that affects approximately three million people in the United States. Furthermore, non-celiac gluten sensitivity (NCGS) affects an estimated additional 6% of the population, e.g., 20 million in the U.S. The only effective treatment of CD and NCGS requires complete removal of gluten sources from the diet. While required adherence to a gluten-free diet (GFD) is extremely difficult to accomplish, efforts to develop additional supportive treatments are needed. To facilitate these efforts, we developed a gluten-sensitive (GS) rhesus macaque model to study the effects of novel therapies. Recently reported results from phase one of this project suggest that partial improvement-but not remission-of gluten-induced disease can be accomplished by 100-fold reduction of dietary gluten, i.e., 200 ppm-by replacement of conventional dietary sources of gluten with a mutant, reduced gluten (RG) barley (lys3a)-derived source. The main focus of this (phase two) study was to determine if the inflammatory effects of the residual gluten in lys3a mutant barley grain could be further reduced by oral supplementation with a prolylendopeptidase (PE). Results reveal that PE supplementation of RG barley diet induces more complete immunological, histopathological and clinical remission than RG barley diet alone. The combined effects of RG barley diet and PE supplementation resulted in a further decrease of inflammatory mediators IFN-γ and TNF secretion by peripheral lymphocytes, as well as decreased plasma anti-gliadin and anti-intestinal tissue transglutaminase (TG2) antibodies, diminished active caspase production in small intestinal mucosa, and eliminated clinical diarrhea-all comparable with a gluten-free diet induced remission. In summary, the beneficial results of a combined RG barley and PE administration in GS macaques may warrant the investigation of similar synergistic approaches.