Metabolic and Bio-behavioral Effects of Following Recommendations in the Dietary Guidelines for A… (NCT04293224) | Clinical Trial Compass
RecruitingNot Applicable
Metabolic and Bio-behavioral Effects of Following Recommendations in the Dietary Guidelines for Americans
United States70 participantsStarted 2022-08-01
Plain-language 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.)
Who can participate
Age range
19 Years – 64 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in body weight
Timeframe: Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28
Trial details
NCT IDNCT04293224
SponsorUSDA, Western Human Nutrition Research Center