Scientific Standards for Human Intervention Trials Evaluating Health Benefits of Foods, and Their Application to Infants, Children and Adolescents

Author(s):  
Jayne V. Woodside ◽  
Berthold V. Koletzko ◽  
Chris C. Patterson ◽  
Robert W. Welch
2018 ◽  
Vol 9 (4) ◽  
pp. 1944-1966 ◽  
Author(s):  
José J. van den Driessche ◽  
Jogchum Plat ◽  
Ronald P. Mensink

A new term was introduced recently to describe foods with additional health benefits: “superfoods”, for which up to date no generally accepted definitions exist. Nonetheless, their consumption might contribute to the prevention of metabolic syndrome.


Author(s):  
Tom Clifford ◽  
Jarred P. Acton ◽  
Stuart P. Cocksedge ◽  
Kelly A. Bowden Davies ◽  
Stephen J. Bailey

AbstractWe conducted a systematic review of human trials examining the effects of dietary phytochemicals on Nrf2 activation. In accordance with the PRISMA guidelines, Medline, Embase and CAB abstracts were searched for articles from inception until March 2020. Studies in adult humans that measured Nrf2 activation (gene or protein expression changes) following ingestion of a phytochemical, either alone or in combination were included. The study was pre-registered on the Prospero database (Registration Number: CRD42020176121). Twenty-nine full-texts were retrieved and reviewed for analysis; of these, eighteen were included in the systematic review. Most of the included participants were healthy, obese or type 2 diabetics. Study quality was assessed using the Cochrane Collaboration Risk of Bias Assessment tool. Twelve different compounds were examined in the included studies: curcumin, resveratrol and sulforaphane were the most common (n = 3 each). Approximately half of the studies reported increases in Nrf2 activation (n = 10); however, many were of poor quality and had an unclear or high risk of bias. There is currently limited evidence that phytochemicals activate Nrf2 in humans. Well controlled human intervention trials are needed to corroborate the findings from in vitro and animal studies.


2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 596-596
Author(s):  
Priscilla Clayton ◽  
Cristina Palacios,

Abstract Objectives Background: Randomized controlled trials are considered the ‘gold standard’ to assess the efficacy and effectiveness of health care and dietary interventions, however, challenges with recruitment and retention of participants can be detrimental to the validity and generalizability of the study. Children and adolescents play a role in the decision to participate, although parents are the primary decision-makers. Exploring children and parent's knowledge, attitudes, and perceptions towards research can help to understand factors that influence participation and retention. Objective: To identify predictors of recruitment and retention in RCTs involving both parents and children to assist in the implementation of recruitment and retention strategies. Methods A systematic review of RCTs was conducted to explore the available evidence to compose a qualitative meta-summary. Studies were identified from 3 databases and restricted only to English language publications. Data reporting participant's predictors and barriers of recruitment and retention in RCTs involving children and adolescents aged 0 to 21 were identified. Year of publication ranged from 2006 to 2019. Studies not including children and studies not involving participant feedback were excluded. Results 53 records were identified; 32 were excluded due to exclusion of child and/or parent feedback, therefore 21 studies were included. Several themes were identified between parents and children that mentioned predictors: personal health benefit, altruism, trust in the research, contact with staff, benefit for parents themselves, benefit for the community, minimal risk to the child, monetary benefits, felt as the only option, influence by family and friends, recommendation from physician, and increase in knowledge. Barriers mentioned were: felt as the “guinea pig,” burden for child, decision too stressful, fear of randomization, no direct benefit, and time and financial constraints. The most common themes identified in several of the studies were personal health benefits, the risk to the child, altruism, time constraint, and no direct benefit. Conclusions Important predictors of recruitment and retention in RCTs are children's personal health benefits and risks, altruism, time constraint, and no direct benefit. Funding Sources NIH


2017 ◽  
pp. ajcn157172 ◽  
Author(s):  
Kaisa S Poutanen ◽  
Pierre Dussort ◽  
Alfrun Erkner ◽  
Susana Fiszman ◽  
Kavita Karnik ◽  
...  

Nutrients ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 3331
Author(s):  
Roberta Ricotti ◽  
Marina Caputo ◽  
Alice Monzani ◽  
Stella Pigni ◽  
Valentina Antoniotti ◽  
...  

Breakfast skipping increases with age, and an association with a high risk of being overweight (OW) and of obesity (OB), cardiometabolic risk, and unhealthy diet regimen has been demonstrated in observational studies with children and adults. Short-term intervention trials in adults reported conflicting results. The purpose of this systematic review was to summarize the association of breakfast skipping with body weight, metabolic features, and nutrition quality in the groups of young people that underwent randomized controlled (RCT) or intervention longitudinal trials lasting more than two months. We searched relevant databases (2000–2021) and identified 584 articles, of which 16 were suitable for inclusion. Overall, 50,066 children and adolescents were included. No studies analyzed cardiometabolic features. Interventions were efficacious in reducing breakfast skipping prevalence when multi-level approaches were used. Two longitudinal studies reported a high prevalence of OW/OB in breakfast skippers, whereas RCTs had negligible effects. Ten studies reported a lower-quality dietary intake in breakfast skippers. This review provides insight into the fact that breakfast skipping is a modifiable marker of the risk of OW/OB and unhealthy nutritional habits in children and adolescents. Further long-term multi-level intervention studies are needed to investigate the relationship between breakfast, nutrition quality, chronotypes, and cardiometabolic risk in youths.


2011 ◽  
Vol 24 (1) ◽  
pp. 118-131 ◽  
Author(s):  
Caren E. Smith ◽  
Katherine L. Tucker

Cereal fibre and whole-grain intakes have been consistently associated in the epidemiological literature with reduced mortality and risk of chronic disease including obesity, CVD and type 2 diabetes. The present review focuses on intervention trials with three primary aims: (1) understanding the mechanisms through which fibre consumption improves health (for example, examination of intermediate endpoints reflecting improved lipid, glucose and energy metabolism); (2) close evaluation of qualitative factors which modify fibre's effectiveness including physiochemical properties (for example, solubility, fermentability and viscosity), fibre extract molecular weight, fibre particle size and botanical structure of the fibre source grain; and (3) identification of areas in which additional research is needed. The first two aims typify the goals of nutrition research, in that improved understanding of the specific factors which determine fibre's health benefits has critical implications for dietary recommendations as well as improving understanding of physiological mechanisms. The third aim acknowledges the substantial gap between recommended and actual fibre intakes in many developed countries including the USA and the UK. In recognition of this deficit in total fibre intake, food manufacturing processes increasingly utilise fibre extracts and concentrates as food additives. However, whether fibre extracts provide similar health benefits to the fibre supplied in the constituents of whole grain is largely unexplored. The relative benefits of fibre extracts compared with whole-grain fibre sources therefore represent a critical area in which additional research is needed.


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