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Official title Metabolic and Bio-behavioral Effects of Following Recommendations in the Dietary Guidelines for Americans
ClinicalTrials.gov ID: NCT04293224
What this study is testing
- What it's testing
- 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.)
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 64, women only. Healthy volunteers may be eligible.
You may be able to join 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...
You likely can't join 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
See the full eligibility 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...
- 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 \ 200% of upper limit (ALT upper limit is 43 U/L or Aspartate transaminase (AST) upper limit is 54 U/L) and thyroid...
- 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...
- 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...
- Are pregnant, planning to become pregnant within the duration of the study or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Davis, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 19 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Davis, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.