- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01255228
Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese Women
Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese
Excessive body weight and obesity have reached epidemic proportions over the last few decades, which may cause many chronic diseases. Maintaining a healthy life style could decrease the risk for obesity, metabolic syndrome and cardiovascular disease. The study aimed to evaluate long-term low glycemic index (GI) diet intervention on lipid profile, body composition and the mechanism of obese women. The pilot study will recruit twenty healthy subjects, and served test food to determine low GI food. In the experiment period, twenty women age from 20-50 years will be recruited. To be included in the study, subjects should have a BMI above 24 kg/m2, or the either one (fat mass ≧ 30% or waistline > 80 cm). Before dietary intervention, participants will receive food choice table and dietary questionnaires to record their dietary intake.
The study will be a randomized, crossover, controlled clinical trails. The experiment period have six weeks, each participants will provide low GI diet (lunch and dinner). On the 0, 3, 6 week, subjects will measurement their body composition (body weight, body mass, waist and hip circumferences) and collect fasting blood samples to analysis the lipid profile, free fatty acid, blood sugar, insulin, adiponectin, leptin and fatty acid synthesis enzymes. Statistical analysis will be performed by paired t-test. The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Taipei, Taiwan
- Taipei Medical University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI above 24 kg/m2, or the either one ( fat mass ≧ 30% or waistline > 80 cm )
Exclusion Criteria:
- Cardiovascular disease
- type 2 diabetes mellitus or impaired glucose tolerance
- serious liver or renal disease, gastro-intestinal disease
- proceed serious diet control for formerly three months
- take any supplemental food products or medications known to influence lipid or carbohydrate metabolism
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low glycemic index diet
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
|
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
|
|
Experimental: diet intervention
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
|
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the effect of body composition ( body weight,body mass,waist and hip circumferences )
Time Frame: 6 week
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6 week
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jen-Fang Liu, Taipei Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 99055
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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