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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19-64
SponsorUSDA, Western Human Nutrition Research Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • DGA Mediterranean diet pattern, energy balance

    Other intervention

    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.

  • DGA Mediterranean diet pattern, negative energy balance

    Other intervention

    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

  • TAD diet pattern, negative energy balance

    Other intervention

    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.

Treatment groups

70 Participants
are divided into 3 treatment groups
Group A: DGA Mediterranean diet pattern, energy balanceExperimental treatment 1 intervention
Group B: DGA Mediterranean diet pattern, negative energy balanceExperimental treatment 1 intervention
Group C: TAD diet patternExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in body weight

Body weight will be measured to the nearest 0.1 kg using a calibrated electronic scale.

Time frame
Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28

Secondary outcomes

1

Height

Height will be measured to the nearest 0.1 cm using a wall-mounted stadiometer.

Time frame
Week 1
2

Change in body mass index

Body weight and height will be used to calculate Body Mass Index (BMI) as kg/m2.

Time frame
Measured weekly for weeks 1 through 10, and weeks 13, 17, 21, 24 and 28
3

Change in body water (via InBody)

Measured using bioelectrical impedance analysis (BIA) with an InBody 770® expressed as kg.

Time frame
Week 1, 10, 28
4

Change in body fat (via DEXA scan)

Fat mass (grams) will be measured using dual energy x-ray absorptiometry (DEXA).

Time frame
Week 1, 10, 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.