Effects of following dietary guidelines on weight and health

Metabolic and Bio-behavioral Effects of Following Recommendations in the Dietary Guidelines for Americans

This study is testing if following the Dietary Guidelines for Americans can help people lose weight and improve their heart and metabolic health compared to a typical American diet.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 19 Years to 64 Years
• Sex: Female
• Sponsor: USDA, Western Human Nutrition Research Center (fed)
• Locations: 1 site (Davis, California)
• Trial ID: NCT04293224 on ClinicalTrials.gov

What this trial studies

This study at the Western Human Nutrition Research Center investigates the impact of adhering to the Dietary Guidelines for Americans (DGA) on body weight and cardiometabolic health. Participants will undergo a 28-week program that includes pre-diet testing, an 8-week controlled feeding period with different diet patterns, and follow-up assessments. The study aims to determine whether a higher nutrient quality diet during energy restriction leads to better health outcomes compared to a typical American diet. Factors influencing weight management, such as genetics and physical activity, will also be evaluated.

Who should consider this trial

Good fit: Ideal candidates are adults with a BMI between 23 and 39.9 kg/m2 or a body fat percentage of 32-50%, who are willing to participate in dietary interventions.

Not a fit: Patients with severe obesity, certain metabolic disorders, or those currently using tobacco or dietary supplements may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into effective dietary strategies for weight management and improved health outcomes.

How similar studies have performed: Previous studies have shown positive outcomes with similar dietary interventions, suggesting potential for success in this approach.

Eligibility criteria

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 this trial is running

Davis, California

• UC Davis, Western Human Nutrition Research Center — Davis, California, United States (RECRUITING)

Study contacts

• Principal investigator: Kevin D Laugero, PhD — USDA, Western Human Nutrition Research Center
• Study coordinator: Beverly Miller, BS, RDN

Conditions: Obesity, Body Weight, Dietary Guidelines for Americans, Physical Activity for Americans, Mediterranean Diet, Controlled Feeding, Women, PreDiabetes