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

NCT04293224 | Recruiting

• 1 other identifier: FL111
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.)

Conditions

Obesity; Body Weight

Keywords

Dietary Guidelines for Americans; Physical Activity for Americans; Mediterranean Diet; Controlled Feeding; Women; PreDiabetes; Metabolic Syndrome; Cognitive Function; Stress, Physiological; Executive Function; Cardiovascular Diseases; Cardiovascular Risk Factor; Eating Behavior; Glucose Intolerance; Metabolomic Profiling; Metabolic flexibility; Gut Microbiome; Genome Testing; Prehypertension; Insulin Resistance; Insulin Sensitivity; Hypertriglyceridemic; Waist to Hip Ratio; Allostatic Load; Physiology

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Body weight will be measured to the nearest 0.1 kg using a calibrated electronic scale.

  Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28

Secondary Outcomes (65)

• Height

  Week 1

• Change in body mass index

  Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28

• Change in body water (via InBody)

  Week 1, 10, 28

• Change in body fat (via DEXA scan)

  Week 1, 10, 28

• Change in waist circumference

  Week 1, 10, 28

Study Arms (3)

DGA Mediterranean diet pattern, energy balance

EXPERIMENTAL

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.

Other: DGA Mediterranean diet pattern, energy balance

DGA Mediterranean diet pattern, negative energy balance

EXPERIMENTAL

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.

Other: DGA Mediterranean diet pattern, negative energy balance

TAD diet pattern

EXPERIMENTAL

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).

Other: TAD diet pattern, negative energy balance

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, energy balance

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

DGA Mediterranean diet pattern, negative energy balance

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.

TAD diet pattern

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• Active participation in another research study
• Tested positive for COVID-19 within the past 10 days
• Been in close contact with a COVID-19 positive person within the past 14 days
• Blood Pressure (BP): Systolic BP ≥140 mmHg or Diastolic BP ≥90 mmHg
• LDL cholesterol ≥190 mg/dL
• Triglycerides ≥500 mg/dL
• Current use of smoking or chewing tobacco, e-cigarettes, cigars, vaping, cannabis or other use of nicotine containing products (within the past 6 months)
• Current use of dietary supplements and/or unwillingness to cease intake of dietary supplements
• Vegan or vegetarian lifestyle or any other dietary restrictions that would interfere with consuming the intervention foods and beverages (including dietary intolerances, allergies and sensitivities)
• Unwillingness to consume intervention foods and beverages
• Engage in more than moderate drinking (\> 1 drink serving per day) or binge drinking (4 drinks within two hours).
• Unwillingness to cease alcohol intake as required for specific duration of the study
• Excessive intake of caffeine containing products (excessive defined as ≥ 400 mg/day)
• Unwillingness to refrain from caffeine intake on lab visit days.
• Intentional weight change of ≥5% of body weight within 6 months of entry into the study

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead

Study Sites (1)

UC Davis, Western Human Nutrition Research Center

Davis, California, 95616, United States

RECRUITING

Related Publications (1)

• Krishnan S, Adams SH, Allen LH, Laugero KD, Newman JW, Stephensen CB, Burnett DJ, Witbracht M, Welch LC, Que ES, Keim NL. A randomized controlled-feeding trial based on the Dietary Guidelines for Americans on cardiometabolic health indexes. Am J Clin Nutr. 2018 Aug 1;108(2):266-278. doi: 10.1093/ajcn/nqy113.

  PMID: 30101333 BACKGROUND

Related Links

• WHNRC website

MeSH Terms

Conditions

Obesity; Body Weight; Prediabetic State; Metabolic Syndrome; Cardiovascular Diseases; Feeding Behavior; Glucose Intolerance; Prehypertension; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Behavior, Animal; Behavior; Hyperglycemia; Vascular Diseases

Study Officials

• Kevin D Laugero, PhD

  USDA, Western Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beverly Miller, BS, RDN

CONTACT

530-754-2541; bevmiller@ucdavis.edu

Ellen Bonnel, PhD

CONTACT

530-752-4184; ellen.bonnel@usda.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 3, 2020
• Study Start: August 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

US (1)