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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01186393
First received: August 19, 2010
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Behavioral: Control
Behavioral: Low -GI
Behavioral: High - GI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: CCRC: Assessing the Role of Glycemic Index in Body Weight Management and Glucose Control

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glucose tolerance [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: May 2007
Estimated Study Completion Date: September 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control With Dietitian Meetings
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 Name: 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 -GI
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 Name: 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 - GI
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 Name: High glycemic index reduced energy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186393

Locations
United States, California
University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)
Davis, California, United States, 95616
VA Hospital, Mather
Mather, California, United States, 95655
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Britt Burton-Freeman, Ph.D University of California, Davis
Principal Investigator: C. Tissa Kappagoda, MD University of California, Davis
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01186393     History of Changes
Other Study ID Numbers: 200715352
Study First Received: August 19, 2010
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Weight Loss
Potatoes
Dietary Meetings
Glycemic Control

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013