Obesity Clinical Trial
Official title:
Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese
Verified date | December 2010 |
Source | Taipei Medical University WanFang Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | April 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 50 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Medical University | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University WanFang Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the effect of body composition ( body weight,body mass,waist and hip circumferences ) | 6 week | No |
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