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Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese Women

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Low glycemic index diet
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring obesity, body composition, adipocyte-derived cytokine, low glycemic index

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low glycemic index diet

diet intervention

Arm Description

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

Outcomes

Primary Outcome Measures

the effect of body composition ( body weight,body mass,waist and hip circumferences )

Secondary Outcome Measures

Full Information

First Posted
November 18, 2010
Last Updated
December 5, 2010
Sponsor
Taipei Medical University WanFang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01255228
Brief Title
Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese Women
Official Title
Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Taipei Medical University WanFang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, body composition, adipocyte-derived cytokine, low glycemic index

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low glycemic index diet
Arm Type
Experimental
Arm Description
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
Arm Title
diet intervention
Arm Type
Experimental
Arm Description
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
Intervention Type
Other
Intervention Name(s)
Low glycemic index diet
Intervention Description
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
Primary Outcome Measure Information:
Title
the effect of body composition ( body weight,body mass,waist and hip circumferences )
Time Frame
6 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jen-Fang Liu
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese Women

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