STUDY: Effects of Potatoes in a Weight Loss Program (BBFUSPB)

May 14, 2015 updated by: University of California, Davis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)
      • Mather, California, United States, 95655
        • VA Hospital, Mather

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Control
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.
Other Names:
  • No energy reduction
Experimental: 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.
Behavioral: 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.
Other Names:
  • Low glycemic index reduced energy
Experimental: 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.
Behavioral: 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 Low Glycemic Index foods.
Other Names:
  • High glycemic index reduced energy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight Loss
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Body composition
Time Frame: 12 weeks
12 weeks
Blood Pressure
Time Frame: 12 weeks
12 weeks
Glucose tolerance
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: C. Tissa Kappagoda, MD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 19, 2010

First Submitted That Met QC Criteria

August 19, 2010

First Posted (Estimate)

August 23, 2010

Study Record Updates

Last Update Posted (Estimate)

May 18, 2015

Last Update Submitted That Met QC Criteria

May 14, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200715352

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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