About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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%
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
DGA Mediterranean diet pattern, energy balance
Other interventionFoods 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.
DGA Mediterranean diet pattern, negative energy balance
Other interventionFoods 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
TAD diet pattern, negative energy balance
Other interventionFoods 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in body weight
Body weight will be measured to the nearest 0.1 kg using a calibrated electronic scale.
Secondary outcomes
Height
Height will be measured to the nearest 0.1 cm using a wall-mounted stadiometer.
Change in body mass index
Body weight and height will be used to calculate Body Mass Index (BMI) as kg/m2.
Change in body water (via InBody)
Measured using bioelectrical impedance analysis (BIA) with an InBody 770® expressed as kg.
Change in body fat (via DEXA scan)
Fat mass (grams) will be measured using dual energy x-ray absorptiometry (DEXA).
Sponsors and contacts
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