STUDY: Effects of Potatoes in a Weight Loss Program

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Control; Behavioral: Low Glycemic Index; Behavioral: High Glycemic Index

• Registration Number: NCT01186393
• Lead Sponsor: University of California, Davis

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 Timeline

• Study Start: 2007-05
• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-19
• Study First Posted: 2010-08-23
• Primary Completion: 2010-11
• Study Completion: 2014-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-14
• Last Update Posted: 2015-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	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.
Low Glycemic Index	Low Glycemic Index	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.
High Glycemic Index	High Glycemic Index	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.

Primary Outcome Measures

Name	Time	Method
Weight Loss	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Glucose tolerance	12 Weeks
Body composition	12 weeks
Blood Pressure	12 weeks

Trial Locations

Locations (2)

University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility); 🇺🇸 Davis, California, United States

VA Hospital, Mather; 🇺🇸 Mather, California, United States