Status:
COMPLETED
Replace Glycemic Load and Satiety Study
Lead Sponsor:
Pennington Biomedical Research Center
Collaborating Sponsors:
General Mills
Conditions:
Glucose Blood
Glycemic Index
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The study is to examine the effect of four diets differing in glycemic index and amount of carbohydrate on blood sugar and insulin and in hunger, satiety, and vigor.
Detailed Description
The extent to which a food raises blood sugar after its consumption is ranked using the Glycemic Index (GI). Foods with a high GI are those taht cause a large and rapid rise in blood sugar while those...
Eligibility Criteria
Inclusion
- Body Mass index between 25-35 kg/m2
- Fasting serum glucose
- Fasting serum glucose \< 125 mg/dl
- Free of chronic disease
- Willing to eat only the foods that are provided by the Center during the diet periods
- Willing to abstain from the consumption of alcohol during the diet periods
- Regularly cycling and willing not to become pregnant using birth control (abstinence, barrier methods, partner surgically sterile
- Monophasic birth control (same dose each day)
- Hormone replacement therapy
- Post-menopausal (over 1 year without bleeding)
- Have had partial hysterectomy over the age of 55
- complete hysterectomy at any age
Exclusion
- Documented presence of atherosclerotic disease
- Diabetes mellitus
- Renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease
- Body Mass Index \<25 or \> 35
- History of drug or alcohol abuse in the last year
- For women, pregnancy, breast feeding or postpartum \< 6 months
- History of depression or mental illness requiring treatment or medication within that last 6 months
- Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence
- Lifestyle or schedule incompatible with the study protocol
- Planned continued use of dietary supplements through the study trial
- Smoking or tobacco use
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01516333
Start Date
February 1 2007
End Date
June 1 2007
Last Update
December 18 2015
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808