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Diet design for a multicenter controlled feeding trial: the DELTA program. Delta Research Group
B H Dennis1, P Stewart, C H Wang
1Department of Nutrition, School of Public Health, University of North Carolina, Chapel Hill 27514-4145, USA.
Journal of the American Dietetic Association
|July 17, 1998
Summary
Standardizing diets in multicenter studies is crucial. The DELTA-1 study successfully validated and monitored experimental diets, ensuring nutrient targets were met across all sites.
Area of Science:
- Nutrition Science
- Dietary Research
- Clinical Trials
Background:
- The Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA-1) study aimed to assess fat's impact on lipoproteins and hemostasis.
- Standardizing diets is critical for the validity of multicenter human feeding studies.
Purpose of the Study:
- To detail the methods and outcomes of diet standardization, validation, and monitoring in the DELTA-1 protocol.
- To ensure experimental diets met precise nutrient specifications across multiple research centers.
Main Methods:
- Employed a randomized, blinded, crossover design with 103 participants across 4 centers.
- Standardized diets (37%, 30%, and 26% fat) through central food procurement, precise weighing, and standardized procedures.
- Validated menus via chemical assay and monitored diet composition through regular sampling and analysis.
Main Results:
- Successfully provided a standardized diet meeting nutrient specifications across 4 field centers.
- Achieved consistent diet composition over 24 weeks of participant feeding (8 months total).
Conclusions:
- Prestudy chemical validation and continuous diet monitoring are essential for standardizing experimental diets.
- These rigorous methods ensure nutrient target goals are met and maintained in controlled multicenter feeding studies.