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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01186393 |
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Date of registration:
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19/08/2010 |
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Primary sponsor: |
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Public title:
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STUDY: Effects of Potatoes in a Weight Loss Program
BBFUSPB |
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Scientific title:
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CCRC: Assessing the Role of Glycemic Index in Body Weight Management and Glucose Control |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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90 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01186393 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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Countries of recruitment
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United States
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Contacts
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Name:
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Britt Burton-Freeman, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, Davis |
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Name:
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C. Tissa Kappagoda, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, Davis |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Behavioral: Control
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Behavioral: High - GI
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Behavioral: Low -GI
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Primary Outcome(s)
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Weight Loss
[Time Frame: 12 Weeks]
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Secondary Outcome(s)
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Blood Pressure
[Time Frame: 12 weeks]
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Body composition
[Time Frame: 12 weeks]
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Glucose tolerance
[Time Frame: 12 Weeks]
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Secondary ID(s)
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200715352
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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