Status:
RECRUITING
Metabolic and Bio-behavioral Effects of Following Recommendations in the Dietary Guidelines for Americans
Lead Sponsor:
USDA, Western Human Nutrition Research Center
Conditions:
Obesity
Body Weight
Eligibility:
FEMALE
19-64 years
Phase:
NA
Brief 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 o...
Detailed Description
This will be a 28-week study including pre-diet testing (week 1), an 8-week controlled feeding period, post-diet testing (week 10), a follow-up period of dietary education and observation, and end of ...
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.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04293224
Start Date
August 1 2022
End Date
September 30 2026
Last Update
December 17 2025
Active Locations (1)
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1
UC Davis, Western Human Nutrition Research Center
Davis, California, United States, 95616