NCT04293224 · USDA, Western Human Nutrition Research Center
Metabolic and Bio-behavioral Effects of Following Recommendations in the Dietary Guidelines for Americans
(DGA4ME)
What this study is about
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).
View original scientific description
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.
Interventions
OTHER
DGA Mediterranean diet pattern, energy balance
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.
OTHER
DGA Mediterranean diet pattern, negative energy balance
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
OTHER
TAD diet pattern, negative energy balance
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.
Primary outcome measures
Change in body weight
Time frame: Measured 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Davis, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 30, 2026 · Source of record for eligibility and locations