NCT04293224Completed
Metabolic and Bio-behavioral Effects of Following Recommendations in the Dietary Guidelines for Americans
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.)
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 54 (actual)
- First submitted
- 27 Feb 2020
- Start date
- 1 Aug 2022
- Primary completion date
- 30 Jul 2026
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Diseases
- Obesity
- NCT number
- NCT04293224
What you commit to
- Study type: Interventional
- Participants enrolled: 54
- From 1 Aug 2022 to the primary completion date, 30 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking any medication in the class of antipsychotics
Other illness
- 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
- 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)
- Diagnosis of disordered eating or eating disorder
- 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
Lab values
- LDL cholesterol ≥190 mg/dL
- Triglycerides ≥500 mg/dL
- 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).
- 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).
Other
- Active participation in another research study
- Blood Pressure (BP): Systolic BP ≥140 mmHg or Diastolic BP ≥90 mmHg
- 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
- 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
- Long term use of antibiotics
- Are pregnant, planning to become pregnant within the duration of the study or breastfeeding.
Who the study is looking for
- 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%
Age in the registry: 19 years to 64 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UC Davis, Western Human Nutrition Research Center Coordinator of this site? Confirm its status | Davis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.