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Perspective: Design and Conduct of Human Nutrition Randomized Controlled Trials
- Source :
- Advances in Nutrition
- Publication Year :
- 2020
-
Abstract
- 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.
- Subjects :
- Gerontology
retention
Blinding
design
Psychological intervention
Medicine (miscellaneous)
Nutritional Status
Context (language use)
030204 cardiovascular system & hematology
law.invention
03 medical and health sciences
AcademicSubjects/MED00060
0302 clinical medicine
Randomized controlled trial
law
Outcome Assessment, Health Care
Medicine
Humans
Generalizability theory
030212 general & internal medicine
adherence
Research question
Randomized Controlled Trials as Topic
Nutrition and Dietetics
business.industry
screening
scientific integrity
Systematic review
nutrition
recruitment
Research Design
Data quality
Perspective
randomized controlled trials
Nutrition Therapy
business
diet
Food Science
Subjects
Details
- ISSN :
- 21565376
- Volume :
- 12
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Advances in nutrition (Bethesda, Md.)
- Accession number :
- edsair.doi.dedup.....75883ffedfccd273f5a59e333b07a1fe