Journal of Dietary Supplements最新文献

{"title":"Validation and Comparison of Live Microorganism Plating Analytical Procedures Following United States Pharmacopeia (USP) <1220> and <1210>.","authors":"M L Jane Weitzel, Marco Pane, Christina S Vegge, Scott A Jackson, Binu Koshy, Virginia S Goldman, Pierre Burguière, Jean-Marc Roussel, Jean L Schoeni","doi":"10.1080/19390211.2025.2583511","DOIUrl":"10.1080/19390211.2025.2583511","url":null,"abstract":"<p><p>Properly validated procedures can reduce variation and lead to data that is more accurate and precise. Analytical procedure lifecycle management (APLM) is a statistical approach based on uncertainty measurements that validates procedures by demonstrating they are fit for purpose. APLM results can also be used to compare procedures. This paper builds upon previous publications that introduced, developed, and demonstrated the application of APLM as described in USP <1220> to a microbiological analytical procedure. The application of APLM is demonstrated in two MS EXCEL workbooks that are provided: <i>Template APLM</i>, that can be used to apply APLM to any microbiological plate count procedure and <i>Case Study APLM</i> detailing the APLM validation and comparison of enumeration procedures associated with a <i>Lactobacillus acidophilus</i> probiotic ingredient. The measurand and analytical target profile are clearly defined, a risk assessment is documented, and an analytical control strategy created. Two different procedures, ISO 20128 and USP <64>, are compared using tolerance intervals (TI) calculated from the procedures' uncertainties. Tools to ease validation and comparison and all required statistical equations are contained within the workbooks. Case study data, which is based on a <i>Lactobacillus acidophilus</i>, single-strain, powdered ingredient, was generated in a manufacturing facility laboratory. This example of using APLM validated ISO 20128 as fit for the purpose of enumerating L. acidophilus in a powdered probiotic ingredient by showing that the intermediate precision (0.062 log₁₀ CFU/g) was less than the target measurement uncertainty (0.097 log₁₀ CFU/g). When comparing ISO 20128 to USP <64> overlapping tolerance intervals were observed; 11.14-11.76 log₁₀ CFU/g and 11.41 to 11.62 log₁₀ CFU/g, respectively. The results indicate the procedures are similar, but not equivalent. Options for using APLM and TI information are discussed. This study shows that APLM and tolerance intervals are useful tools that improve and ease procedure selection, assist in information gathering that leads to better understanding and control of analytical procedures, and helps improve data quality.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"76-100"},"PeriodicalIF":2.3,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145513038","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dietary Supplement-Induced Hepatotoxicity: A Clinical Perspective.","authors":"Jordan Carty, Victor J Navarro","doi":"10.1080/19390211.2024.2327546","DOIUrl":"10.1080/19390211.2024.2327546","url":null,"abstract":"<p><p>The consumption of dietary supplements (DS) has resulted in a significant and escalating number of cases involving liver injury. It is crucial for clinicians and consumers to be well informed about the adverse effects of such products, leading to their discontinuation and timely reporting of any harmful cases. This article delves into the clinical perspective of DS-related hepatotoxicity, highlighting key concepts such as a systematic diagnostic approach. The discussion extends to notable examples of both currently popular and potential future dietary supplements, such as garcinia cambogia, turmeric, and ashwagandha, accompanied by an overview of recent findings. Causality assessment tools play a crucial role in establishing a connection between these products and instances of liver injury, with consideration of the advantages and disadvantages associated with their use. Fostering a comprehensive understanding of regulatory standards, coupled with a solid foundation of knowledge of DS, will prove instrumental in preventing DS-related hepatotoxicity. Achieving this goal requires collaborative efforts from both consumers and clinicians.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"58-77"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140287561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of Ketone Ester Supplementation on Cognition and Appetite in Individuals with and Without Metabolic syndrome: A Randomized Trial.","authors":"Austin J Graybeal, Ryan S Aultman, Caleb F Brandner, Anabelle Vallecillo-Bustos, Abby T Compton, Sydney H Swafford, Ta'Quoris A Newsome, Jon Stavres","doi":"10.1080/19390211.2025.2473371","DOIUrl":"10.1080/19390211.2025.2473371","url":null,"abstract":"<p><p>There are currently no non-pharmacological solutions to combat the appetite and cognitive dysfunctions associated with metabolic syndrome (MetS). Ketosis may be a potential solution, though the restrictive nature of dietary ketosis limits its long-term utility. Oral administration of exogenous ketone esters (KE) independently induces ketosis, eliciting hyperketonemia without the need for prolonged dietary restrictions. However, the acute effects of oral KEs on appetite and cognition have not been evaluated in individuals with MetS. For this randomized, single-blind, placebo-controlled, matched-pairs crossover study, 10 individuals with MetS and 10 without (non-MetS) matched for age, sex, and race/ethnicity completed a cardiometabolic screening/familiarization visit and two experimental trials. During the experimental trials, cognitive function, subjective appetite, and respiratory gases were measured at baseline and for 2h following the ingestion of a randomly assigned KE or placebo drink. Post-trial food intake was also collected. Independent of MetS group, indices of working memory significantly improved (<i>p</i> ≤ .035), and blood glucose significantly decreased (<i>p</i> < .001), following KE ingestion. However, after the KE condition, markers of subjective appetite (<i>p</i> ≤ .048) only decreased in the non-MetS group. Post-trial relative fat intake was higher in the MetS group than the non-MetS group following the KE (<i>p</i> = .002), and lower after the KE than the placebo for the non-MetS group (<i>p</i> = .028). Our findings indicate that while cognitive function may increase following KE ingestion independent of MetS, appetite may only decrease in those without MetS; providing further insight to our understanding of the behavioral and metabolic responses to exogenous ketosis.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"382-400"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12018118/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143557021","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of Coenzyme Q10, Tryptophan, and Magnesium Supplementation on Fatigue in Patients with Fibromyalgia - A Randomized Trial.","authors":"Lluís Rosselló Aubach, Xavier Fornós Roca, María Elena Fernández Álvarez","doi":"10.1080/19390211.2025.2483269","DOIUrl":"10.1080/19390211.2025.2483269","url":null,"abstract":"<p><p>Fibromyalgia (FM) is a prevalent and multifactorial condition requiring pharmacological and non-pharmacological interventions for its management. Coenzyme Q10 (CoQ10), magnesium, and tryptophan are associated with FM symptoms, but their combined effects in this condition are poorly understood. The objective of the study was to assess the effects of CoQ10, tryptophan, and magnesium supplementation in patients with FM. This single-center, randomized, double-blind, placebo-controlled, two-period, two-sequence crossover study included adult patients diagnosed with FM for at least two years. The study comprised two periods of three months each, and a one-month washout period between them. Participants were randomized to receive the dietary supplement or placebo. The primary endpoint was the change in the item fatigue of the combined index of fibromyalgia impact in patients (ICAF). Secondary outcomes included changes in the remaining ICAF factors and items and in the total score. Of 110 enrolled patients, 89 (mean age: 51.0 years; 96.6% women) completed the study. Most participants (94.4%) were on pharmacological treatment for FM. Fatigue improved significantly in the placebo group, with a non-significant reduction in the dietary supplement group. Pain intensity significantly decreased in both groups, while sleep quality and functional impact showed a significant reduction in the dietary supplement group. The ICAF total score improved significantly after 3 months of receiving the dietary supplement. Adverse events (<i>n</i> = 35) were mild and homogenously distributed between groups. The dietary supplement was efficacious in improving physical aspects of FM, including pain, sleep quality, and impact, and showed good tolerability.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"433-444"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143730289","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of Nano-Quercetin on Cypermethrin Induced Liver Injury in Rabbits.","authors":"Maham Ashraf, Bushra Akhtar, Chi-Chung Chou, Muhammad Saeed, Faqir Muhammad","doi":"10.1080/19390211.2025.2507612","DOIUrl":"10.1080/19390211.2025.2507612","url":null,"abstract":"<p><p>Cypermethrin is a synthetic pyrethroid reported to cause hepatic toxicity and other fatalities in humans as well as animals/birds. Quercetin is a flavonoid that has beneficial health-protective effects, its use is limited because of its poor bioavailability, metabolism through colonic microbial flora, and first-pass hepatic metabolism. To overcome these limitations, quercetin was loaded into chitosan nanoparticles by following the solvent evaporation method. The study objectives were synthesizing, characterizing quercetin-loaded chitosan nanoparticles, and determination of hepatoprotective potential against chemical (pyrethroid) induced liver injury in animal models. The nanoparticles were characterized by zeta size and potential, polydispersity index (PDI), entrapment efficiency, and FTIR. The prepared nano-formulation was physically stable and fell within the nanoscale range (188.5 nm) with high entrapment efficiency (80.4%). The study was conducted with four treatment groups (<i>n</i> = 5) comprising 20 rabbits, in which group 1 was the negative control (normal diet), group 2 was a positive control (cypermethrin 24 mg/Kg), group 3 and 4 were treated with low-dose (10 mg/kg) and high-dose (20 mg/kg) quercetin-loaded chitosan nanoparticles respectively, along with cypermethrin 24 mg/kg) for 28 days. It was found that cypermethrin-treated animals have high levels of LFT and histopathological lesions in the liver. Co-administration of quercetin-loaded chitosan nanoparticles with cypermethrin successfully ameliorated hepatotoxicity in rabbits in a dose-dependent manner.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"571-583"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vitamins and Iron-Deficiency Gestational Anemia - A Review.","authors":"Dinesh Venkatesan Yadav, Tridip Mitra, Deeksha Punniyamoorthy, Anuradha Murugesan, Sajeetha Kumari Raveendran, Rajiv Janardhanan","doi":"10.1080/19390211.2025.2555013","DOIUrl":"10.1080/19390211.2025.2555013","url":null,"abstract":"<p><p>Vitamins, as essential m icronutrients, are vital for numerous cellular functions and play a key role in maintaining hematological parameter s during pregnancy, including erythropoiesis and processes affecting iron status. Iron-Deficient Gestational Anemia (IDGA), the most common clinicopathological condition in obstetrics and highly prevalent in developing countries, significantly contributes to complications such as hypertensive disorders of pregnancy and gestational diabetes. While it is recognized that vitamin deficiencies impact iron metabolism and erythropoiesis, a complete understanding of their specific roles in preventing and managing IDGA is lacking. Insights into how vitamin deficiencies influence gene expression and cellular signaling are crucial. With rising IDGA prevalence, ensuring adequate vitamin intake during pregnancy is essential for improving hematological health. Mobile health-based literacy tools can effectively promote patient education to achieve this. This review underscores the critical role of vitamins in regulating hemoglobin levels in IDGA.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"887-906"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145023497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Revisiting the Definition of 'Healthy' Participants in Substantiation of Structure/Function Claims for Dietary Supplements.","authors":"Malkanthi Evans, Erin D Lewis, Joseph M Antony, David C Crowley, Andrew Charrette, Najla Guthrie, Jeffrey B Blumberg, Gregor Reid","doi":"10.1080/19390211.2023.2301383","DOIUrl":"10.1080/19390211.2023.2301383","url":null,"abstract":"<p><p>Concepts and definitions of 'healthy' have been evolving within clinical treatment algorithms as well as reference standards such as Body Mass Index and Dietary Reference Intakes. Consumers' perception of the word 'healthy' is also changing to reflect longer life span, need to stay active and in a good state of mental well-being while managing multiple diseases. Guidelines from the US Food and Drug Administration indicate that substantiating evidence for support of Structure/Function (S/F) claims for dietary supplements is best derived from clinical research conducted in a 'healthy' population. S/F claims cannot be represented to diagnose, treat, cure or prevent any disease. However, in this context, the term 'healthy' is non-descriptive and largely interpreted as an absence of disease. Guidelines for treatment of disease have been broadened to include biomarkers of disease risk such that the pool of 'healthy' volunteers eligible to be enrolled in clinical trials for S/F claim substantiation is greatly diminished. This perspective presents the challenges faced by the food and dietary supplement industry and by researcher efforts designed to substantiate S/F claims and suggest the phrase 'physiologically stable' or 'apparently healthy' as descriptions better suited to replace the term 'healthy.'</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"41-57"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139650884","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Review of Probiotic Ingredient Safety Supporting Monograph Development Conducted by the United States Pharmacopeia (USP).","authors":"Marie-Eve Boyte, Nadeem Akhtar, Binu Koshy, Amy L Roe","doi":"10.1080/19390211.2024.2314488","DOIUrl":"10.1080/19390211.2024.2314488","url":null,"abstract":"<p><p>The United States Pharmacopeia (USP) is an independent, nonprofit science-based organization whose mission is to improve global health through public standards and related products for medicines, food and dietary supplements. Probiotic-based dietary supplements are increasingly popular in the marketplace and USP has developed fourteen monographs specific to probiotic ingredients, including representatives from the Genera <i>Lactobacillus, Bacillus, Streptococcus, and Bifidobacterium</i>. These monographs include the definition of the article, tests for identification, quantification assays (enumeration in the case of probiotics), limits for contaminants, and other quality parameters when appropriate. In addition to quality, the USP also considers the safety of probiotics for monograph development. This report includes an overview of the USP admission evaluation process for probiotics as well as a tabular summary of the probiotic monographs currently available. Pharmacopeia monographs can guide manufacturers and brand owners and protect consumers through establishment of quality standards.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"123-161"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139735377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Yeast Beta-Glucan Enhances Antibody Response Following Influenza Vaccination - A Double-Blind, Randomized, Placebo-Controlled Pilot Trial.","authors":"Melissa L Moreno, Carmelo J Nieves, Kaylan Hebert, Camilo A Vivas, Daniela Rivero-Mendoza, James Colee, Thomas A Tompkins, Wendy J Dahl","doi":"10.1080/19390211.2025.2539876","DOIUrl":"10.1080/19390211.2025.2539876","url":null,"abstract":"<p><p>Yeast beta-glucans demonstrate immune-modulating effects; however, few studies have explored the potential of yeast beta-glucans to enhance immune response to vaccination. This pilot study aimed to assess the adjuvant effect of a yeast beta-glucan supplementation on antibody titer response to influenza vaccination. Adults (<i>n</i> = 90; 70.7 ± 10.1 years) were recruited over two vaccination seasons and randomized to receive 500 mg of beta-glucan or placebo (500 mg cellulose) daily in a double-blind study design. Pre- and 4 wk post-vaccination serum influenza-specific antibody titers were assessed using an optimized Hemagglutination Inhibition (HI) assay. Plasma cytokines 24 h post-vaccination were quantified by immunoassay. Cold and flu symptoms, using the Modified Jackson Criteria, fever, and self-perceived fatigue were monitored daily. Linear mixed models were used to test for differences in the fixed effects of time, treatment, and their interactions. In season 1 (Fall 2022), despite a baseline suggesting seroprotection for the Influenza A (H3N2 A/Wisconsin/67/2005) in 92% of the beta-glucan group and 74% of the placebo group, the post-vaccination antibody titer response (Δ = 95.8) favored beta-glucan over placebo (<i>p</i> = 0.037). Influenza B/Austria/1359417/2021 antigen demonstrated poor detection; 7 of the 10 HI detectible antibody responses seen were in the beta-glucan group. In season 2 (Fall 2023), the Influenza A (H1N1 A/Victoria/4897/2022) antigen demonstrated poor detection (14%), which precluded further cohort analyses. Of the cytokines, interferon-gamma (IFN-γ) increased similarly in both groups after vaccination, not supporting the adjuvant action of beta-glucan at the cellular level. Reported cold and flu symptoms were low in both groups and did not differ. Overall, the findings suggest that yeast beta-glucan supplementation may elicit a greater change in antibody titer to seasonal influenza vaccination. However, confirmation is needed with a larger sample of older adults and with follow-up to assess protection from disease. Clinical trial registry number and website: https://clinicaltrials.gov/study/NCT05074303.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"795-810"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144760234","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Authentication Methods for Phytochemicals (Botanicals) in Plant Extracts and Dietary Supplements.","authors":"Santhosh Kumar J Urumarudappa, Vijay Bommuluri, Saravanan J, Smita Chaturvedi, Ashutosh Kumar Mittal, Yanjun Zhang, Peter Chang, Gary Swanson","doi":"10.1080/19390211.2025.2538487","DOIUrl":"10.1080/19390211.2025.2538487","url":null,"abstract":"<p><p>Demand for high-quality and standardized phytochemicals (botanicals) and plant extracts if rising in both the food and dietary supplement industries. Ensuring the authenticity of the plant raw materials used in botanical and dietary supplement manufacturing is an important step before processing raw materials. However, authenticating phytochemicals (botanicals) are challenging due to their unique characteristics, including geographical location, seasonal variations, environmental conditions, and plant diversity. These factors cause variability in properties, making consistent authentication methods difficult to establish. The current review is centered on the utilization of multisource and qualitative methods for authenticating the identity of botanical and food ingredients. This review highlights the integral role of various botanicals and plant extracts authentication methods such as micro/macroscopy, chromatography, and spectroscopy technology, including DNA-based approaches. Further summarizing the current state of knowledge and importance its potential contributions to the field of botanical ingredient authentication system. This study also highlights the plants used in dietary supplement categories of weight management, memory enhancement and blood sugar regulation and their adulteration/admixture. Furthermore, discusses considerations for selecting appropriate methods and optimization steps in the implementation and standardization of botanical and plant extract authentication. In addition, we discussed the challenges and opportunities associated with the implementation and standardization of botanical and plant extracts authentication system. The future of botanical authentication will be shaped by advances in molecular diagnostics such as targeted DNA barcoding, Next-Generation Sequencing (NGS), and chemometric integration with spectroscopic techniques which are set to greatly enhance accuracy, traceability, and global compliance in botanical product safety and quality.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"680-721"},"PeriodicalIF":2.3,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144812034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}