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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Low Glycemic Index
High Glycemic Index
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Weight Loss, Potatoes, Dietary Meetings, Glycemic Control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control

Low Glycemic Index

High Glycemic Index

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Weight Loss

Secondary Outcome Measures

Glucose tolerance
Body composition
Blood Pressure

Full Information

First Posted
August 19, 2010
Last Updated
May 14, 2015
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT01186393
Brief Title
STUDY: Effects of Potatoes in a Weight Loss Program
Acronym
BBFUSPB
Official Title
CCRC: Assessing the Role of Glycemic Index in Body Weight Management and Glucose Control
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight Loss, Potatoes, Dietary Meetings, Glycemic Control

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
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.
Arm Title
Low Glycemic Index
Arm Type
Experimental
Arm Description
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.
Arm Title
High Glycemic Index
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Other Intervention Name(s)
No energy reduction
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low Glycemic Index
Other Intervention Name(s)
Low glycemic index reduced energy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
High Glycemic Index
Other Intervention Name(s)
High glycemic index reduced energy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight Loss
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Glucose tolerance
Time Frame
12 Weeks
Title
Body composition
Time Frame
12 weeks
Title
Blood Pressure
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Britt Burton-Freeman, Ph.D
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
C. Tissa Kappagoda, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
VA Hospital, Mather
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25302575
Citation
Randolph JM, Edirisinghe I, Masoni AM, Kappagoda T, Burton-Freeman B. Potatoes, glycemic index, and weight loss in free-living individuals: practical implications. J Am Coll Nutr. 2014;33(5):375-84. doi: 10.1080/07315724.2013.875441. Epub 2014 Oct 10.
Results Reference
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STUDY: Effects of Potatoes in a Weight Loss Program

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