RecruitingNot ApplicableNCT04293224

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

Sponsor

USDA, Western Human Nutrition Research Center

Enrollment

70 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

Obesity Body Weight

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.)

Eligibility

Sex: FEMALEMin Age: 19 YearsMax Age: 64 Years

Inclusion Criteria3

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 Criteria23

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.

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Interventions

OTHERDGA Mediterranean diet pattern, energy balance

Foods and beverages will be provided for participants for eight weeks. During the controlled feeding portion of the study the DGA Mediterranean diet pattern will be based on the Table A7-1 of the 2015 Dietary Guidelines for Americans which outlines daily nutritional goals for age-sex groups based on Dietary Reference Intakes (DRI) and dietary guidelines recommendations.

OTHERDGA Mediterranean diet pattern, negative energy balance

OTHERTAD diet pattern, negative energy balance

Foods and beverages will be provided for participants for eight weeks. During the controlled feeding portion of the study the be based on evidence collected from What We Eat in America (WWEIA) data. Based on this data the participants will be provided a diet that reflects American dietary trends.