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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.)

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 35
Maximum Age: 64
Healthy Volunteers: t
View:

• Body Mass Index (BMI) 23-39.9 kg/m2 or 32-50% body fat percentage

• Willingness to have blood drawn

• The criteria listed above and at least one of the following: Fasting glucose ≥100 mg/dL but \<126 mg/dL or Fasting triglyceride ≥125 mg/dL or HDL-cholesterol ≤50 mg/dL or Blood Pressure (BP): Systolic BP ≥130 mmHg or Diastolic BP ≥85 mmHg or Hemoglobin A1C ≥ 5.7 and \<6.5%

Locations
United States
California
UC Davis, Western Human Nutrition Research Center
RECRUITING
Davis
Contact Information
Primary
Beverly Miller, BS, RDN
bevmiller@ucdavis.edu
530-754-2541
Backup
Ellen Bonnel, PhD
ellen.bonnel@usda.gov
530-752-4184
Time Frame
Start Date: 2022-08-01
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 123
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: USDA, Western Human Nutrition Research Center

This content was sourced from clinicaltrials.gov