Metabolic and Bio-behavioral Effects of Following Recommendations in the Dietary Guidelines for Americans

Part of paid clinical trials in Davis, California.

Sponsor
USDA, Western Human Nutrition Research Center
Study ID
NCT04293224
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
19 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • DGA Mediterranean diet pattern, energy balance — OTHER
    Foods and beverages will be provided for participants for eight weeks. During the controlled feeding portion of the study the DGA Mediterranean diet pattern will be based on the Table A7-1 of the 2015 Dietary Guidelines for Americans which outlines daily nutritional goals for age-sex groups based on Dietary Reference Intakes (DRI) and dietary guidelines recommendations.
  • DGA Mediterranean diet pattern, negative energy balance — OTHER
    Foods and beverages will be provided for participants for eight weeks. During the controlled feeding portion of the study the DGA Mediterranean diet pattern will be based on the Table A7-1 of the 2015 Dietary Guidelines for Americans which outlines daily nutritional goals for age-sex groups based on Dietary Reference Intakes (DRI) and dietary guidelines recommendations
  • TAD diet pattern, negative energy balance — OTHER
    Foods and beverages will be provided for participants for eight weeks. During the controlled feeding portion of the study the be based on evidence collected from What We Eat in America (WWEIA) data. Based on this data the participants will be provided a diet that reflects American dietary trends.

Study Details

This study, at the Western Human Nutrition Research Center (WHNRC), will focus on whether or not achieving and maintaining a healthy body weight is the most important health promoting recommendation of the Dietary Guidelines for Americans (DGA).The investigators hypothesize that improvement in cardiometabolic risk factors resulting from eating a DGA style diet will be greater in people whose energy intake is restricted to result in weight loss compared to those who maintain their weight. The investigators further propose that during a state of energy restriction, a higher nutrient quality diet such as the DGA style diet pattern, will result in greater improvement in cardiometabolic risk factors compared to a typical American diet (TAD) pattern that tends to be lower nutrient quality (more energy-dense and less nutrient-rich.)

Key Dates

Start date
Aug 1, 2022
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: DGA Mediterranean diet pattern, energy balance
    Diet plan focused on energy balance (meets calorie needs), emphasizes fruits, vegetables and whole grains and limits calories from added sugars and saturated fats and reduces sodium intake per Dietary Guidelines for Americans (DGA) recommendations.
  • Experimental: DGA Mediterranean diet pattern, negative energy balance
    Negative energy balance (\~25% calorie reduction compared to needs), emphasizes fruits, vegetables and whole grains and limits calories from added sugars and saturated fats and reduces sodium intake per Dietary Guidelines for Americans (DGA) recommendations.
  • Experimental: TAD diet pattern
    Typical American Diet (TAD) with negative energy balance (\~25% calorie reduction compared to needs) which mimics intake of fruits, vegetables, whole grains, added sugars, saturated fats and sodium based on data from What We Eat in America (WWEIA).

Primary Outcome Measure

Change in body weight [ Time Frame: Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis, Western Human Nutrition Research CenterDavisCalifornia95616-

Find similar trials in Davis, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
UC Davis, Western Human Nutrition Research Center· Davis, CA

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