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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

August 19, 2010
July 3, 2012
May 2007
November 2010   (final data collection date for primary outcome measure)
Weight Loss [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01186393 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
STUDY: Effects of Potatoes in a Weight Loss Program
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Obesity
  • 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
  • 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
  • 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
  • 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.
    Intervention: Behavioral: Control
  • 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.
    Intervention: Behavioral: Low -GI
  • 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.
    Intervention: Behavioral: High - GI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
September 2012
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01186393
200715352
No
University of California, Davis
University of California, Davis
Not Provided
Principal Investigator: Britt Burton-Freeman, Ph.D University of California, Davis
Principal Investigator: C. Tissa Kappagoda, MD University of California, Davis
University of California, Davis
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP