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1,542 result(s) for "Supplement intervention trial"
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Indicators of improved emotion behavior in 6–14-year-old children following a 4-week placebo controlled prebiotic supplement intervention at home with a parent
Background In this double-blind placebo-controlled randomised intervention we investigated the potential benefits of a prebiotic supplement on children’s well-being in a home setting. The primary aim was to determine if this supplement could effectively reduce anxiety, improve mood, and enhance cognitive function, similar to findings in young adults. Methods Fifty-three healthy children, aged 6 to 14, participated in an 8-week trial. The trial consisted of three testing time points; day zero marked the baseline measurement (T1) followed by a 28-day supplement intervention period during which they consumed 5.5 g of the prebiotic galactooligosaccharides (GOS) daily under parental guidance. Endline measures (T2) were conducted on the last day of supplement consumption, with a final follow-up testing session (T3) on day 56. Primary outcomes were trait anxiety using a questionnaire and emotional behavior in a dot-probe task on responses to positive and negative images. Secondary outcomes encompassed depression levels, cognitive function tests, and dietary intake recorded in a 4-day food diary. Additionally, we explored whether parents’ emotional behavior had an impact on children’s responses. Results While our statistical analysis did not reveal significant effects of GOS, there were noteworthy trends. Trait anxiety levels decreased over time in both groups, with a more pronounced decrease in the GOS group (after intervention, p  =.090; after follow-up, p  =.031). The GOS group exhibited reduced negative emotional responses compared to the placebo group ( p  =.105), and post-trial depression levels decreased in the GOS group over time ( p  =.015). Although parental emotional responses correlated with various emotional outcomes in children, they did not influence the intervention effects. Conclusions These findings suggest positive trends in line with our hypotheses, however further investigation with greater statistical power would be beneficial. Trial registration Retrospectively registered on https://clinicaltrials.gov/ [NCT06258135] on February 6, 2024.
A systematic review, meta-analysis and meta-regression of the effect of protein supplementation on resistance training-induced gains in muscle mass and strength in healthy adults
ObjectiveWe performed a systematic review, meta-analysis and meta-regression to determine if dietary protein supplementation augments resistance exercise training (RET)-induced gains in muscle mass and strength.Data sourcesA systematic search of Medline, Embase, CINAHL and SportDiscus.Eligibility criteriaOnly randomised controlled trials with RET ≥6 weeks in duration and dietary protein supplementation.DesignRandom-effects meta-analyses and meta-regressions with four a priori determined covariates. Two-phase break point analysis was used to determine the relationship between total protein intake and changes in fat-free mass (FFM).ResultsData from 49 studies with 1863 participants showed that dietary protein supplementation significantly (all p<0.05) increased changes (means (95% CI)) in: strength—one-repetition-maximum (2.49 kg (0.64, 4.33)), FFM (0.30 kg (0.09, 0.52)) and muscle size—muscle fibre cross-sectional area (CSA; 310 µm2 (51, 570)) and mid-femur CSA (7.2 mm2 (0.20, 14.30)) during periods of prolonged RET. The impact of protein supplementation on gains in FFM was reduced with increasing age (−0.01 kg (−0.02,–0.00), p=0.002) and was more effective in resistance-trained individuals (0.75 kg (0.09, 1.40), p=0.03). Protein supplementation beyond total protein intakes of 1.62 g/kg/day resulted in no further RET-induced gains in FFM.Summary/conclusionDietary protein supplementation significantly enhanced changes in muscle strength and size during prolonged RET in healthy adults. Increasing age reduces and training experience increases the efficacy of protein supplementation during RET. With protein supplementation, protein intakes at amounts greater than ~1.6 g/kg/day do not further contribute RET-induced gains in FFM.
Improving Cognitive Function with Nutritional Supplements in Aging: A Comprehensive Narrative Review of Clinical Studies Investigating the Effects of Vitamins, Minerals, Antioxidants, and Other Dietary Supplements
Cognitive impairment and dementia are burgeoning public health concerns, especially given the increasing longevity of the global population. These conditions not only affect the quality of life of individuals and their families, but also pose significant economic burdens on healthcare systems. In this context, our comprehensive narrative review critically examines the role of nutritional supplements in mitigating cognitive decline. Amidst growing interest in non-pharmacological interventions for cognitive enhancement, this review delves into the efficacy of vitamins, minerals, antioxidants, and other dietary supplements. Through a systematic evaluation of randomized controlled trials, observational studies, and meta-analysis, this review focuses on outcomes such as memory enhancement, attention improvement, executive function support, and neuroprotection. The findings suggest a complex interplay between nutritional supplementation and cognitive health, with some supplements showing promising results and others displaying limited or context-dependent effectiveness. The review highlights the importance of dosage, bioavailability, and individual differences in response to supplementation. Additionally, it addresses safety concerns and potential interactions with conventional treatments. By providing a clear overview of current scientific knowledge, this review aims to guide healthcare professionals and researchers in making informed decisions about the use of nutritional supplements for cognitive health.
Marine n−3 Fatty Acids and Prevention of Cardiovascular Disease and Cancer
This article reports the n−3 fatty acid portion of a randomized, placebo-controlled, two-by-two factorial trial of vitamin D and marine n−3 fatty acids in the primary prevention of cancer and cardiovascular disease. Fatty acids did not lead to a lower incidence of major cardiovascular events or cancer.
Early interventions to prevent psychosis: systematic review and meta-analysis
Objective To determine whether any psychological, pharmacological, or nutritional interventions can prevent or delay transition to psychotic disorders for people at high risk.Design Systematic review and meta-analysis. Data sources Embase, Medline, PreMedline, PsycINFO, and CENTRAL were searched to November 2011 without restriction to publication status. Review methods Randomised trials comparing any psychological, pharmacological, nutritional, or combined intervention with usual services or another treatment. Studies of participants with a formal diagnosis of schizophrenia or bipolar disorder were excluded. Studies were assessed for bias, and relevant limitations were considered in summarising the results.Results 11 trials including 1246 participants and eight comparisons were included. Median sample size of included trials was 81 (range 51-288). Meta-analyses were performed for transition to psychosis, symptoms of psychosis, depression, and mania; quality of life; weight; and discontinuation of treatment. Evidence of moderate quality showed an effect for cognitive behavioural therapy on reducing transition to psychosis at 12 months (risk ratio 0.54 (95% confidence interval 0.34 to 0.86); risk difference −0.07 (−0.14 to −0.01). Very low quality evidence for omega-3 fatty acids and low to very low quality evidence for integrated psychotherapy also indicated that these interventions were associated with reductions in transition to psychosis at 12 months.Conclusions Although evidence of benefits for any specific intervention is not conclusive, these findings suggest that it might be possible to delay or prevent transition to psychosis. Further research should be undertaken to establish conclusively the potential for benefit of psychological interventions in the treatment of people at high risk of psychosis.
Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study
To investigate the adherence of randomised controlled trial (RCT) protocols evaluating non-regulated interventions (including dietary interventions, surgical procedures, behavioural and lifestyle interventions, and exercise programmes) in comparison with regulated interventions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement. We conducted a repeated cross-sectional investigation in a random sample of RCT protocols approved in 2012 (n = 257) or 2016 (n = 292) by research ethics committees in Switzerland, Germany, or Canada. We investigated the proportion of accurately reported SPIRIT checklist items in protocols of trials with non-regulated as compared to regulated interventions. Overall, 131 (24%) of trial protocols tested non-regulated interventions. In 2012, the median proportion of SPIRIT items reported in these protocols (59%, interquartile range [IQR], 53%-69%) was lower than in protocols with regulated interventions (median, 74%, IQR, 66%-80%). In 2016, the reporting quality of protocols with non-regulated interventions (median, 75%, IQR, 62%-83%) improved to the level of regulated intervention protocols, which had not changed on average. Reporting of RCT protocols evaluating non-regulated interventions improved between 2012 and 2016, although remained suboptimal. SPIRIT recommendations need to be further endorsed by researchers, ethics committees, funding agencies, and journals to optimize reporting of RCT protocols.
Effectiveness of school-based nutrition interventions in sub-Saharan Africa: a systematic review
To evaluate the effect of school-based nutrition interventions (SBNI) involving schoolchildren and adolescents in sub-Saharan Africa (SSA) on child nutrition status and nutrition-related knowledge, attitudes and behaviour. A systematic review on published school nutrition intervention studies of randomised controlled trials, controlled clinical trials, controlled before-and-after studies or quasi-experimental designs with control. Nine electronic bibliographic databases were searched. To be included, interventions had to involve changes to the school's physical and social environments, to the school's nutrition policies, to teaching curriculum to incorporate nutrition education and/or to partnership with parents/community. Schools in SSA. School-aged children and adolescents, aged 5-19 years. Fourteen studies met our inclusion criteria. While there are few existing studies of SBNI in SSA, the evidence shows that food supplementation/fortification is very effective in reducing micronutrient deficiencies and can improve nutrition status. Secondly, school nutrition education can improve nutrition knowledge, but this may not necessarily translate into healthy nutrition behaviour, indicating that nutrition knowledge may have little impact without a facilitating environment. Results regarding anthropometry were inconclusive; however, there is evidence for the effectiveness of SBNI in improving cognitive abilities. There is enough evidence to warrant further trials of SBNI in SSA. Future research should consider investigating the impact of SBNI on anthropometry and nutrition behaviour, focusing on the role of programme intensity and/or duration. To address the high incidence of micronutrient deficiencies in low- and middle-income countries, food supplementation strategies currently available to schoolchildren should be expanded.
Effects of food supplementation on cognitive function, cerebral blood flow, and nutritional status in young children at risk of undernutrition: randomized controlled trial
AbstractObjectiveTo assess the effects of food supplementation on improving working memory and additional measures including cerebral blood flow in children at risk of undernutrition.DesignRandomized controlled trial.Setting10 villages in Guinea-Bissau.Participants1059 children aged 15 months to 7 years; children younger than 4 were the primary population.InterventionsSupervised isocaloric servings (≈1300 kJ, five mornings each week, 23 weeks) of a new food supplement (NEWSUP, high in plant polyphenols and omega 3 fatty acids, within a wide variety and high fortification of micronutrients, and a high protein content), or a fortified blended food (FBF) used in nutrition programs, or a control meal (traditional rice breakfast).Main outcome measurementsThe primary outcome was working memory, a core executive function predicting long term academic achievement. Additional outcomes were hemoglobin concentration, growth, body composition, and index of cerebral blood flow (CBFi). In addition to an intention-to-treat analysis, a predefined per protocol analysis was conducted in children who consumed at least 75% of the supplement (820/925, 89%). The primary outcome was assessed by a multivariable Poisson model; other outcomes were assessed by multivariable linear mixed models.ResultsAmong children younger than 4, randomization to NEWSUP increased working memory compared with the control meal (rate ratio 1.20, 95% confidence interval 1.02 to 1.41, P=0.03), with a larger effect in the per protocol population (1.25, 1.06 to 1.47, P=0.009). NEWSUP also increased hemoglobin concentration among children with anemia (adjusted mean difference 0.65 g/dL, 95% confidence interval 0.23 to 1.07, P=0.003) compared with the control meal, decreased body mass index z score gain (−0.23, −0.43 to −0.02, P=0.03), and increased lean tissue accretion (2.98 cm2, 0.04 to 5.92, P=0.046) with less fat (−5.82 cm2, −11.28 to −0.36, P=0.04) compared with FBF. Additionally, NEWSUP increased CBFi compared with the control meal and FBF in both age groups combined (1.14 mm2/s×10−8, 0.10 to 2.23, P=0.04 for both comparisons). Among children aged 4 and older, NEWSUP had no significant effect on working memory or anemia, but increased lean tissue compared with FBF (4.31 cm2, 0.34 to 8.28, P=0.03).ConclusionsChildhood undernutrition is associated with long term impairment in cognition. Contrary to current understanding, supplementary feeding for 23 weeks could improve executive function, brain health, and nutritional status in vulnerable young children living in low income countries. Further research is needed to optimize nutritional prescriptions for regenerative improvements in cognitive function, and to test effectiveness in other vulnerable groups.Trial registrationClinicalTrials.gov NCT03017209.
Effects of a leucine-enriched amino acid supplement on muscle mass, muscle strength, and physical function in post-stroke patients with sarcopenia: A randomized controlled trial
•Older patients undergoing stroke rehabilitation are at high risk for sarcopenia and malnutrition.•We examined the efficacy and safety of a leucine-enriched amino acid supplement in post-stroke older patients with sarcopenia.•To our knowledge, this is the first interventional trial including nutritional supplementation in such patients.•Study outcomes included muscle mass, muscle strength, and physical function.•A leucin-enriched nutritional supplement increased muscle mass, strength, and physical function in this population. The aim of this study was to investigate the effects of a leucine-enriched amino acid supplement on muscle mass, muscle strength, and physical function in post-stroke patients with sarcopenia. We conducted an eight-wk, two-parallel group intervention, randomized controlled, blinded outcome assessment among 44 post-stroke older patients with sarcopenia. Sarcopenia was defined as a loss of skeletal muscle mass and decreased muscle strength according to the Asian Working Group for Sarcopenia criteria. The intervention group (n = 21) received a leucine-enriched amino acid supplement; the control group (n = 23) did not. Both groups performed low-intensity resistance training in addition to a post-stroke rehabilitation program. A primary outcome of physical function by using the motor domain of Functional Independence Measure (FIM), and secondary outcomes of appendicular muscle mass (skeletal muscle mass index [SMI]) measured via bioelectrical impedance analysis and muscle strength as handgrip strength were measured at baseline and at the end of the intervention. The FIM score increased significantly in both groups over time (P < 0.01), with significantly greater improvement in the intervention group than in the control group (P < 0.045). Handgrip strength also increased significantly over time (P <0.05), with significantly greater improvement in the intervention group (P < 0.01). The SMI increased significantly in the intervention group but not in the control group over time, with significantly greater improvement in the intervention group (median estimated difference, 0.50 kg/m2; 95% confidence interval, 0.01–2.11). We demonstrated that an eight-wk intervention consisting of a leucine-enriched amino acid supplementation and low-intensity resistance training increased muscle mass, strength, and physical function in post-stroke patients with sarcopenia.
Effects of a diverse prebiotic fibre supplement on HbA1c, insulin sensitivity and inflammatory biomarkers in pre-diabetes: a pilot placebo-controlled randomised clinical trial
Prebiotic fibre represents a promising and efficacious treatment to manage pre-diabetes, acting via complementary pathways involving the gut microbiome and viscosity-related properties. In this study, we evaluated the effect of using a diverse prebiotic fibre supplement on glycaemic, lipid and inflammatory biomarkers in patients with pre-diabetes. Sixty-six patients diagnosed with pre-diabetes (yet not receiving glucose-lowering medications) were randomised into treatment (thirty-three) and placebo (thirty-three) interventions. Participants in the treatment arm consumed 20 g/d of a diverse prebiotic fibre supplement, and participants in the placebo arm consumed 2 g/d of cellulose for 24 weeks. A total of fifty-one and forty-eight participants completed the week 16 and week 24 visits, respectively. The intervention was well tolerated, with a high average adherence rate across groups. Our results extend upon previous work, showing a significant change in glycated haemoglobin (HbA1c) in the treatment group but only in participants with lower baseline HbA1c levels (< 6 % HbA1c) (P = 0·05; treatment –0·17 ± 0·27 v. placebo 0·07 ± 0·29, mean ± sd). Within the whole cohort, we showed significant improvements in insulin sensitivity (P = 0·03; treatment 1·62 ± 5·79 v. placebo –0·77 ± 2·11) and C-reactive protein (P FWE = 0·03; treatment –2·02 ± 6·42 v. placebo 0·94 ± 2·28) in the treatment group compared with the placebo. Together, our results support the use of a diverse prebiotic fibre supplement for physiologically relevant biomarkers in pre-diabetes.