CCRC: Assessing the Role of Glycemic Index in Body Weight Management and Glucose Control
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 90
- Locations
- 4
- Primary Endpoint
- Weight Loss
Study Overview
Brief Summary
The purpose of this study is to test whether diets that contain potatoes and differ in glycemic index/load will be useful in weight loss, blood sugar control and maintaining current body weight.
Detailed Description
The study will examine the effect of including potatoes as part of a calorie restricted diet designed to induce weight loss and improve glycemic control in overweight subjects.
This is a randomized, treatment-controlled, 3-arm, parallel study. The 3 arms of the study will include dietary manipulation in the free-living setting to include potatoes/potato products frequently in the diet (5-7 days / week). Two diets will be energy-restricted (~ 500 kcal deficit /d) for weight loss and the control diet will be prescribed for weight maintenance. The two energy-restricted diets will include further manipulation, such that, one dietary plan will be a high glycemic index (GI) diet and the other a low glycemic index diet.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men and women
- •≥ 18 years of age who have a body mass index (BMI) of 25 to 35 kg/m2 (inclusive).
Exclusion Criteria
- •Total cholesterol (TC) not greater than 300 mg/dL,
- •Fasting triglyceride not greater than 300 mg/dL ,
- •LDL cholesterol (LDL-C) not greater than 180 mg/dL,
- •Female subjects who are pregnant or lactating
- •Subjects taking any medications that would interfere with outcomes of the study
- •Subjects with unusual dietary habits (eg., pica)
- •Subjects who are actively losing weight or trying to lose weight
- •Subjects who are addicted to drugs or alcohol or who are < 1 y in recovery program
- •Subjects who present with significant psychiatric or neurological disturbances
- •Subjects with known allergy or intolerance to potato products
- •Subjects with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, uncontrolled hypertension ( 140/90 mm Hg), chronic lung, renal or liver disease
Outcomes
Primary Outcomes
Weight Loss
Time Frame: 12 Weeks
Secondary Outcomes
- Glucose tolerance(12 Weeks)
- Body composition(12 weeks)
- Blood Pressure(12 weeks)