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Dietary Guidelines for Americans and Weight Management Study

This study at the Western Human Nutrition Research Center is looking at how different diets affect body weight and heart health markers in women. Researchers want to know if following the Dietary Guidelines for Americans (DGA) is more effective for improving health when it leads to weight loss, compared to maintaining weight. You would be assigned one of three diets: a DGA Mediterranean diet to maintain weight, a DGA Mediterranean diet for weight loss, or a typical American diet for weight loss. The main goal is to see how much your body weight changes over time. The study is for women aged 19-64 who are overweight or obese and have certain health factors like high blood sugar, high triglycerides, low "good" cholesterol (HDL), or high blood pressure.

Study design
This is an interventional study with 70 planned participants. You would be randomly assigned to one of three diet groups.
What's involved
The study lasts 28 weeks, including an 8-week period where all your food and drinks are provided. You will have blood drawn and your weight measured weekly for part of the study.
Compensation
Not stated in the trial record.
Follow-up
After the 8-week controlled feeding period, there will be a follow-up period of dietary education and observation until week 28.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04293224

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

Completed
NAAges 19–64InterventionalBasic science
USDA, Western Human Nutrition Research Center
~54 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:DGA Mediterranean diet pattern, energy balanceDGA Mediterranean diet pattern, negative energy balanceTAD diet pattern, negative energy balance

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in body weight
Measured over Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28

Conditions

Obesity
Body Weight

Explore related trials

Insulin ResistanceMetabolic SyndromeObesityPrediabetesPrehypertension

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Kevin D Laugero, PhD · PRINCIPAL_INVESTIGATOR · USDA, Western Human Nutrition Research Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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%

Exclusion

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
Diagnosis of disordered eating or eating disorder
Recent diagnosis of any of the following or measurement on screening lab tests: Anemia (hemoglobin \<11.7 g/dL) or abnormal liver or thyroid function (defined as liver enzymes that are \>200% of upper limit (ALT upper limit is 43 U/L or Aspartate transaminase (AST) upper limit is 54 U/L) and thyroid function tests: Thyroxine (T4, free) \<0.56 or \>1.64 ng/dL; Thyroid-stimulating hormone (TSH) \<0.35 or \>5.6 μIU/mL).
History of any of the following: Gastric bypass surgery, inflammatory bowel disease (IBD) or other GI conditions that would interfere with consuming the intervention foods, active cancer in the past three years excluding squamous or basal cell carcinomas of the skin that have been handled medically by local excision and other serious medical conditions
Recent dental work or have conditions of the oral cavity that would interfere with consuming the intervention foods and beverages
Taking any medication in the class of antipsychotics
Long term use of antibiotics
Taking any over the counter or prescribed medication for any of the following: Elevated lipids, elevated glucose, high blood pressure, weight loss or conditions that require corticosteroids (e.g. asthma, arthritis or eczema).
Are pregnant, planning to become pregnant within the duration of the study or breastfeeding.

What this trial measures

  • Change in body weightMeasured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28

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