Diet design for a multicenter controlled feeding trial

The DELTA program

Barbara H. Dennis, Paul Stewart, Chin Hua Wang, Catherine Champagne, Marlene Windhauser, Abby Ershow, Wahida Karmally, Katherine Phillips, Kent Stewart, Nancy Van Heel, Abir Farhat-Wood, Penny Margaret Kris-Etherton

Research output: Contribution to journalArticle

22 Citations (Scopus)

Abstract

Objective: To describe the process and results of diet standardization, diet validation, and monitoring of diet composition, which were key components of protocol 1 of Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA-1), the initial protocol in a program of multicenter human feeding studies designed to evaluate the effects of amount and type of fat on lipoprotein and hemostasis parameters in various demographic groups. Design: DELTA-1 was based on a randomized, blinded, crossover experimental design. Three diets were fed for 8 weeks to 103 healthy men and women aged 22 to 67 years at 4 field centers. Diet A, an average American diet, was designed to provide 37% of energy from fat, 16% of energy from saturated fatty acids (SFAs); diet B (step 1 diet) was designed to provide 30% of energy from fat, 9% of energy from SFA; and diet C (low SFA diet) was designed to provide 26% of energy from fat, 5% of energy from SFA. Key features of diet standardization included central procurement of fat-containing foods, inclusion of standard ingredients, precision weighing of foods-especially sources of fat and cholesterol-and use of standardized written procedures. Setting: For menu validation, a set of 12 menus for each diet was prepared in duplicate and chemically assayed. For monitoring of diet composition during the study, an 8-day diet cycle (6 weekday and 2 weekend menus) was sampled by every field center twice during each of 3 feeding periods. Statistical analyses: Means (±standard error) were calculated and compared with target nutrient specifications. Results: DELTA-1 was able to provide a standardized diet that met nutrient specifications across 4 field centers over 24 weeks of participant feeding spanning a total of 8 months. Applications: Prestudy chemical validation of menus and continuous sampling and assay of diets throughout the study are essential to standardize experimental diets and to ensure that nutrient target goals are met and maintained throughout a controlled multicenter feeding study.

Original languageEnglish (US)
Pages (from-to)766-776
Number of pages11
JournalJournal of the American Dietetic Association
Volume98
Issue number7
DOIs
StatePublished - Jan 1 1998

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Diet
diet
menu planning
Fats
saturated fatty acids
energy
lipids
Food
Fatty Acids
standardization
lipoproteins
nutrients
Lipoproteins
hemostasis
monitoring
diet study techniques
experimental diets
Hemostasis
Cross-Over Studies
Multicenter Studies

All Science Journal Classification (ASJC) codes

  • Food Science
  • Nutrition and Dietetics

Cite this

Dennis, Barbara H. ; Stewart, Paul ; Wang, Chin Hua ; Champagne, Catherine ; Windhauser, Marlene ; Ershow, Abby ; Karmally, Wahida ; Phillips, Katherine ; Stewart, Kent ; Van Heel, Nancy ; Farhat-Wood, Abir ; Kris-Etherton, Penny Margaret. / Diet design for a multicenter controlled feeding trial : The DELTA program. In: Journal of the American Dietetic Association. 1998 ; Vol. 98, No. 7. pp. 766-776.
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title = "Diet design for a multicenter controlled feeding trial: The DELTA program",
abstract = "Objective: To describe the process and results of diet standardization, diet validation, and monitoring of diet composition, which were key components of protocol 1 of Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA-1), the initial protocol in a program of multicenter human feeding studies designed to evaluate the effects of amount and type of fat on lipoprotein and hemostasis parameters in various demographic groups. Design: DELTA-1 was based on a randomized, blinded, crossover experimental design. Three diets were fed for 8 weeks to 103 healthy men and women aged 22 to 67 years at 4 field centers. Diet A, an average American diet, was designed to provide 37{\%} of energy from fat, 16{\%} of energy from saturated fatty acids (SFAs); diet B (step 1 diet) was designed to provide 30{\%} of energy from fat, 9{\%} of energy from SFA; and diet C (low SFA diet) was designed to provide 26{\%} of energy from fat, 5{\%} of energy from SFA. Key features of diet standardization included central procurement of fat-containing foods, inclusion of standard ingredients, precision weighing of foods-especially sources of fat and cholesterol-and use of standardized written procedures. Setting: For menu validation, a set of 12 menus for each diet was prepared in duplicate and chemically assayed. For monitoring of diet composition during the study, an 8-day diet cycle (6 weekday and 2 weekend menus) was sampled by every field center twice during each of 3 feeding periods. Statistical analyses: Means (±standard error) were calculated and compared with target nutrient specifications. Results: DELTA-1 was able to provide a standardized diet that met nutrient specifications across 4 field centers over 24 weeks of participant feeding spanning a total of 8 months. Applications: Prestudy chemical validation of menus and continuous sampling and assay of diets throughout the study are essential to standardize experimental diets and to ensure that nutrient target goals are met and maintained throughout a controlled multicenter feeding study.",
author = "Dennis, {Barbara H.} and Paul Stewart and Wang, {Chin Hua} and Catherine Champagne and Marlene Windhauser and Abby Ershow and Wahida Karmally and Katherine Phillips and Kent Stewart and {Van Heel}, Nancy and Abir Farhat-Wood and Kris-Etherton, {Penny Margaret}",
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Dennis, BH, Stewart, P, Wang, CH, Champagne, C, Windhauser, M, Ershow, A, Karmally, W, Phillips, K, Stewart, K, Van Heel, N, Farhat-Wood, A & Kris-Etherton, PM 1998, 'Diet design for a multicenter controlled feeding trial: The DELTA program', Journal of the American Dietetic Association, vol. 98, no. 7, pp. 766-776. https://doi.org/10.1016/S0002-8223(98)00173-4

Diet design for a multicenter controlled feeding trial : The DELTA program. / Dennis, Barbara H.; Stewart, Paul; Wang, Chin Hua; Champagne, Catherine; Windhauser, Marlene; Ershow, Abby; Karmally, Wahida; Phillips, Katherine; Stewart, Kent; Van Heel, Nancy; Farhat-Wood, Abir; Kris-Etherton, Penny Margaret.

In: Journal of the American Dietetic Association, Vol. 98, No. 7, 01.01.1998, p. 766-776.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Diet design for a multicenter controlled feeding trial

T2 - The DELTA program

AU - Dennis, Barbara H.

AU - Stewart, Paul

AU - Wang, Chin Hua

AU - Champagne, Catherine

AU - Windhauser, Marlene

AU - Ershow, Abby

AU - Karmally, Wahida

AU - Phillips, Katherine

AU - Stewart, Kent

AU - Van Heel, Nancy

AU - Farhat-Wood, Abir

AU - Kris-Etherton, Penny Margaret

PY - 1998/1/1

Y1 - 1998/1/1

N2 - Objective: To describe the process and results of diet standardization, diet validation, and monitoring of diet composition, which were key components of protocol 1 of Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA-1), the initial protocol in a program of multicenter human feeding studies designed to evaluate the effects of amount and type of fat on lipoprotein and hemostasis parameters in various demographic groups. Design: DELTA-1 was based on a randomized, blinded, crossover experimental design. Three diets were fed for 8 weeks to 103 healthy men and women aged 22 to 67 years at 4 field centers. Diet A, an average American diet, was designed to provide 37% of energy from fat, 16% of energy from saturated fatty acids (SFAs); diet B (step 1 diet) was designed to provide 30% of energy from fat, 9% of energy from SFA; and diet C (low SFA diet) was designed to provide 26% of energy from fat, 5% of energy from SFA. Key features of diet standardization included central procurement of fat-containing foods, inclusion of standard ingredients, precision weighing of foods-especially sources of fat and cholesterol-and use of standardized written procedures. Setting: For menu validation, a set of 12 menus for each diet was prepared in duplicate and chemically assayed. For monitoring of diet composition during the study, an 8-day diet cycle (6 weekday and 2 weekend menus) was sampled by every field center twice during each of 3 feeding periods. Statistical analyses: Means (±standard error) were calculated and compared with target nutrient specifications. Results: DELTA-1 was able to provide a standardized diet that met nutrient specifications across 4 field centers over 24 weeks of participant feeding spanning a total of 8 months. Applications: Prestudy chemical validation of menus and continuous sampling and assay of diets throughout the study are essential to standardize experimental diets and to ensure that nutrient target goals are met and maintained throughout a controlled multicenter feeding study.

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