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

Launched by USDA, WESTERN HUMAN NUTRITION RESEARCH CENTER · Feb 27, 2020

Keywords

ClinConnect Summary

This clinical trial, taking place at the Western Human Nutrition Research Center, is studying how following the Dietary Guidelines for Americans (DGA) can help people achieve and maintain a healthy body weight. The researchers want to find out if people who eat a healthy DGA-style diet while also reducing their calorie intake will see more improvement in their heart and metabolic health compared to those who maintain their weight. They also aim to compare the effects of this diet against a typical American diet, which is often less nutritious.

To participate in this study, women aged between 18 and 45 with a Body Mass Index (BMI) between 23 and 39.9 or a body fat percentage of 32-50% may qualify, especially if they have specific health markers like higher blood sugar or blood pressure levels. Participants will need to agree to have blood drawn and follow certain dietary guidelines during the study. It’s important to note that those with certain medical conditions, recent surgeries, or specific lifestyle habits, such as smoking or excessive drinking, may not be eligible. If you decide to join, you can expect to learn more about healthy eating and its benefits while contributing to valuable research on obesity and heart health.

Gender

FEMALE

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.