STUDY: Effects of Potatoes in a Weight Loss Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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CCRC: Assessing the Role of Glycemic Index in Body Weight Management and Glucose Control

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Control
* Behavioral: Low Glycemic Index
* Behavioral: High Glycemic Index


Participation Criteria
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Eligibility Criteria
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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, Smokers 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>Arm includes dietary manipulation in the free-living setting to include potatoes/potato products frequently in the diet (5-7 days / week). Control diet will be prescribed for weight maintenance. | Behavioral: Control<br>* Dietary manipulation in the free-living setting to include potatoes/potato products frequently in the diet (5-7 days / week). The control diet will be prescribed for weight maintenance.<br>* Other names: No energy reduction;|
| Experimental: Low Glycemic Index<br>Diets will be energy-restricted (  500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on Low Glycemic Index foods. | Behavioral: Low Glycemic Index<br>* Diets will be energy-restricted (  500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on Low Glycemic Index foods.<br>* Other names: Low glycemic index reduced energy;|
| Experimental: High Glycemic Index<br>Diets will be energy-restricted (  500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on High Glycemic Index foods. | Behavioral: High Glycemic Index<br>* Diets will be energy-restricted (  500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on Low Glycemic Index foods.<br>* Other names: High glycemic index reduced energy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose tolerance |  | 12 Weeks | 
| Body composition |  | 12 weeks | 
| Blood Pressure |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss, Potatoes, Dietary Meetings, Glycemic Control