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Perspective: US Documentation and Regulation of Human Nutrition Randomized Controlled Trials.

ABSTRACT: Training to ensure good documentation practices and adherence to regulatory requirements in human nutrition randomized controlled trials has not been given sufficient attention. Furthermore, it is difficult to find this information conveniently organized or in a form relevant to nutrition protocols. Current gaps in training and research surveillance exist in clinical nutrition research because training modules emphasize drugs and devices, promote reliance on monitoring boards, and lack nutrition expertise on human nutrition research teams. Additionally, because eating is essential, ongoing, and highly individualized, it is difficult to distinguish risks associated with interventions from eating under free-living conditions. Controlled-feeding trials provide an option to gain more experimental control over food consumed, but at a price of less external validity, and may pose human behavior issues that are unrelated to the intervention. This paper covers many of the expected practices for documentation and regulation that may be encountered in planning and conducting nutrition intervention trials with examples and references that should be useful to clinical nutrition researchers, funders of research, and research institutions. Included are definitions and guidance on clinical nutrition research oversight (institutional review boards, data safety and monitoring boards, US FDA); participant safety; standard operating procedures; training of investigators, staff, and students; and local culture and reporting requirements relevant to diet-related clinical research conduct and documentation.

SUBMITTER: Weaver CM

PROVIDER: S-EPMC7850145 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Perspective: Design and Conduct of Human Nutrition Randomized Controlled Trials.

Project description:In the field of human nutrition, randomized controlled trials (RCTs) are considered the gold standard for establishing causal relations between exposure to nutrients, foods, or dietary patterns and prespecified outcome measures, such as body composition, biomarkers, or event rates. Evidence-based dietary guidance is frequently derived from systematic reviews and meta-analyses of these RCTs. Each decision made during the design and conduct of human nutrition RCTs will affect the utility and generalizability of the study results. Within the context of limited resources, the goal is to maximize the generalizability of the findings while producing the highest quality data and maintaining the highest levels of ethics and scientific integrity. The aim of this document is to discuss critical aspects of conducting human nutrition RCTs, including considerations for study design (parallel, crossover, factorial, cluster), institutional ethics approval (institutional review boards), recruitment and screening, intervention implementation, adherence and retention assessment, and statistical analyses considerations. Additional topics include distinguishing between efficacy and effectiveness, defining the research question(s), monitoring biomarker and outcome measures, and collecting and archiving data. Addressed are specific aspects of planning and conducting human nutrition RCTs, including types of interventions, inclusion/exclusion criteria, participant burden, randomization and blinding, trial initiation and monitoring, and the analysis plan.

| S-EPMC7849995 | biostudies-literature

Perspective: Laboratory Considerations and Clinical Data Management for Human Nutrition Randomized Controlled Trials: Guidance for Ensuring Quality and Integrity.

Project description:In human nutrition randomized controlled trials (RCTs), planning, and careful execution of clinical data collection and management are vital for producing valid and reliable results. In this article, we provide an overview of best practices for biospecimen collection and analyses, and for the fundamentals of clinical data management, including preparation and study startup; data collection, entry, cleaning, and authentication; and database lock. The reader is also referred to additional resources for information to assist in the planning and conduct of human RCTs. The tools and strategies described are expected to improve the quality of data produced in human nutrition research that can, therefore, be used to support food and nutrition policies.

| S-EPMC7849975 | biostudies-literature

Ketogenicdiet versus standard high-carbohydrate nutrition in sepsis: a randomized controlled trial

Project description:Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard nutritional approaches relying primarily on carbohydrates. We here hypothesize that a ketogenic diet improves sepsis treatment. We conducted a monocentric open-labeled randomized controlled trial enrolling 40 adult sepsis patients. Patients were randomly assigned to either ketogenic diet (KD) or standard high-carbohydrate nutrition for 14 days and followed up until day 30. The primary outcome measure was β-hydroxybutyrate (BHB) serum concentration on day 14. We assessed feasibility and safety of KD, as well as diet-associated clinical and immunological changes. The respective nutrition protocols were successfully applied, dropouts did not occur. Regression analysis revealed a greater increase in BHB concentrations from baseline to day 14 in KD patients compared to controls. Metabolic side effects were not observed under ketogenic diet. Ventilation-free, vasopressor-free, dialysis-free and ICU-free days significantly increased in patients under ketogenic diet. Transcriptome profiling of both CD4+ and CD8+ T cells at day 14 revealed substantial differential regulation of gene expression in the KD vs. the control group indicating a reduced T-cell activation and a shift towards a more regulated immunity.

2024-06-13 | GSE240861 | GEO

Ketogenic diet versus standard high-carbohydrate nutrition in sepsis: a randomized controlled trial

Project description:Rationale: Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutritional regimes. We therefore hypothesize that a ketogenic diet improves sepsis treatment. Objectives: We investigated the safety and feasibility of a ketogenic diet in sepsis patients. Methods: We conducted a monocentric open-labeled randomized controlled trial (DRKS00017710) enrolling adult sepsis patients randomly assigned to either ketogenic or standard high-carbohydrate diet for 14 days with follow-up until day 30. The primary outcome measure was β-hydroxybutyrate serum concentration on day 14. Secondary outcomes included safety, clinical and immunological changes. Measurements and Main Results: 40 critically ill septic patients were assigned to the study groups. Increase in β-hydroxybutyrate concentrations from baseline to day 14 was markedly greater under ketogenic diet (1.2 ±0.9) compared to controls (-0.3 ±0.4); estimated mean difference 1.4 (95%-CI 1.0-1.8; p<0.0001). During ketogenic diet, no patient required insulin treatment beyond day 4, whereas 35% to 60% of control patients did (p=0.0095). Metabolic side effects were not observed under ketogenic diet. Ventilation-free (IRR 1.7; 95%-CI: 1.5 to 2.1; p<0.0001), vasopressor-free (IRR 1.7; 95%-CI: 1.5 to 2.0; p<0.0001), dialysis-free (IRR 1.5; 95%-CI: 1.3 to 1.8; p<0.0001), and ICU-free days (IRR 1.7; 95%-CI: 1.4 to 2.1; p<0.0001) significantly increased in patients under ketogenic diet. There was no difference in 30-day mortality. Analyses indicated favorable changes towards immune homeostasis. Conclusions: Ketogenic diet is a feasible and safe nutritional regimen in septic patients promoting recovery from sepsis-related organ dysfunction and could become a new tool in modern treatment concepts.

2024-06-13 | PXD046061 | Pride

Nasogastric Nutrition versus Nasojejunal Nutrition in Patients with Severe Acute Pancreatitis: A Meta-Analysis of Randomized Controlled Trials.

Project description:Introduction. Previous studies have shown that the nasogastric (NG) route seems equivalent to the nasojejunal (NJ) route in patients with severe acute pancreatitis (SAP). However, these studies used a small sample size and old criteria for diagnosing SAP, which may include some patients with moderate SAP, according to the newly established SAP criteria (Atlanta 2012 classification). Based on the changes in the criteria for classifying SAP, we performed an up-to-date meta-analysis. Method. We reviewed the PubMed, EMbase, China National Knowledge Infrastructure, Wanfang Database, and Cochrane Central Register of Controlled Trials electronic databases. We included randomized controlled trials comparing NG and NJ nutrition in patients with SAP. We performed the meta-analysis using the Cochrane Collaborations' RevMan 5.3 software. Results. We included four randomized controlled trials involving 237 patients with SAP. There were no significant differences in the incidence of mortality, infectious complications, digestive complications, achievement of energy balance, or length of hospital stay between the NG and NJ nutrition groups. Conclusions. NG nutrition was as safe and effective as NJ nutrition in patients with SAP. Further studies are needed to confirm our results.

| S-EPMC4909901 | biostudies-literature

Effects of omega-3 fatty acid nutrition on mortality in septic patients: a meta-analysis of randomized controlled trials.

Project description:A previous systematic review and meta-analysis reported that omega-3 fatty acids nutrition may reduce mortality in septic patients. As new randomized controlled trials began to accumulate, we conducted an update.A PubMed database was searched through Feb 2016, and randomized controlled trials comparing omega-3 fatty acids with control were selected by two reviewers independently.Eleven trials randomly assigning 808 patients were included in the present study. Using a fixed effects model, we found no significant effect of omega-3 fatty acids on overall mortality (risk ratio 0.84; 95 % confidence interval (CI): 0.67 to 1.05, P?=?0.12), or infectious complications (risk ratio 0.95; 95 % CI: 0.72 to 1.25, P?=?0.70). However, the duration of mechanical ventilation was markedly reduced by omega-3 fatty acids (weighted mean differences (WMD)?=?-3.82; 95 % CI: -4.61 to -3.04; P?<?0.00001). A significant heterogeneity was found when the duration of hospital (I (2)?=?93 %; WMD?=?-2.82; 95 % CI: -9.88 to 4.23, P?=?0.43), or intensive care stay (I (2)?=?87 %; WMD?=?-2.70; 95 % CI: -6.40 to 1.00, P?=?0.15) were investigated.Omega-3 fatty acids confer no mortality benefit but are associated with a reduction in mechanical ventilation duration in septic patients. However, low sample size and heterogeneity of the cohorts included in this analysis limits the generalizability of our findings.

| S-EPMC4950703 | biostudies-other

Does Personalized Nutrition Advice Improve Dietary Intake in Healthy Adults? A Systematic Review of Randomized Controlled Trials.

Project description:Personalized nutrition (PN) behavior-change interventions are being used increasingly in attempts to improve dietary intake; however, the impact of PN advice on improvements in dietary intake has not been reviewed systematically. The aim of this systematic review was to evaluate the effect of PN advice on changes in dietary intake compared with generalized advice in healthy adults. Three databases (EMBASE, PubMed, and CINAHL) were searched between 2009 and 2020 for randomized controlled trials (RCTs) that tested the effect of PN and tailored advice based on diet, phenotype, or genetic information. The Evidence Analysis Library Quality Criteria checklist was used to conduct a risk-of-bias assessment. Information on intervention design and changes in nutrients, foods, and dietary patterns was extracted from the 11 studies meeting the inclusion criteria. Studies were conducted in the United States, Canada, or Europe; reported outcomes on 57 to 1488 participants; and varied in follow-up duration from 1 to 12 mo. Five studies incorporated behavior-change techniques. The risk of bias for included studies was low. Overall, the available evidence suggests that dietary intake is improved to a greater extent in participants randomly assigned to receive PN advice compared with generalized dietary advice. Additional well-designed PN RCTs are needed that incorporate behavior-change techniques, a broader range of dietary outcomes, and comparisons between personalization based on dietary, biological, and/or lifestyle information.

| S-EPMC8166555 | biostudies-literature

The healthy afterschool activity and nutrition documentation instrument.

Project description:BackgroundPolicies call on afterschool programs to improve the physical activity and nutrition habits of youth attending. No tool exists to assess the extent to which the afterschool program environment meets physical activity and nutrition policies.PurposeTo describe the development of the Healthy Afterschool Activity and Nutrition Documentation (HAAND) instrument, which consists of two subscales: Healthy Afterschool Program Index for Physical Activity (HAPI-PA) and the HAPI-Nutrition (HAPI-N).MethodsThirty-nine afterschool programs took part in the HAAND evaluation during fall/spring 2010-2011. Inter-rater reliability data were collected at 20 afterschool programs during a single site visit via direct observation, personal interview, and written document review. Validity of the HAPI-PA was established by comparing HAPI-PA scores to pedometer steps collected in a subsample of 934 children attending 25 of the afterschool programs. Validity of the HAPI-N scores was compared against the mean number of times/week that fruits and vegetables (FV) and whole grains were served in the program.ResultsData were analyzed in June/July 2011. Inter-rater percent agreement was 85%-100% across all items. Increased pedometer steps were associated with the presence of a written policy related to physical activity, amount/quality of staff training, use of a physical activity curriculum, and offering activities that appeal to both genders. Higher servings of FV and whole grains per week were associated with the presence of a written policy regarding the nutritional quality of snacks.ConclusionsThe HAAND instrument is a reliable and valid measurement tool that can be used to assess the physical activity and nutritional environment of afterschool programs.

| S-EPMC3432570 | biostudies-literature

Genomics and Randomized Trials Network (GARNET)

Project description:Genomics and Randomized Trials Network (GARNET)

| PRJNA158493 | ENA

The quality of surgical versus non-surgical randomized controlled trials.

Project description:Randomized controlled trials (RCTs) of surgical interventions are often more difficult to conduct, and their quality may lag behind other trials.To compare quality domains in trials of surgical interventions, to a previously reported control sample of general medical trials from December 2006.MEDLINE, EMBASE and CENTRAL were searched in May 2009.English language, full text RCTs, performed on humans that compared a surgical intervention to any other intervention.Records were ordered according to their date of publication. The most recently published trials were assessed first, until the required sample of 400 trials was obtained. The search and data collection were piloted by three authors, and was thereafter collected by one author. Data was checked.Although most quality domains were poorly reported, surgical trials compared favourably to general medical trials. Surgical trials were 24% more likely to have an adequate method of random sequence generation, and 71% more likely to have an adequate method of allocation concealment. However, blinding was 40% less likely to be adequate in surgical trials, and sources of funding were 33% less likely to be reported.A single author collected most data. Data was checked and this resulted in few changes.Reporting of most quality domains in surgical intervention trials was better than general medical trials. Blinding was less likely due to the difficulty in conducting sham surgical trials, and reporting of sources of support should improve with adherence to reporting guidelines.

| S-EPMC5936696 | biostudies-other

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