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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01255228
First Posted: December 7, 2010
Last Update Posted: December 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Taipei Medical University WanFang Hospital
  Purpose

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.


Condition Intervention
Obesity Other: Low glycemic index diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese

Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • the effect of body composition ( body weight,body mass,waist and hip circumferences ) [ Time Frame: 6 week ]

Estimated Enrollment: 20
Study Start Date: May 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: Low glycemic index diet
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
Other: Low glycemic index diet
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255228


Locations
Taiwan
Taipei Medical University
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Jen-Fang Liu Taipei Medical University
  More Information

Responsible Party: Jen-Fang Liu, Taipei Medical University, School of Nutrition and Health Sciences
ClinicalTrials.gov Identifier: NCT01255228     History of Changes
Other Study ID Numbers: 99055
First Submitted: November 18, 2010
First Posted: December 7, 2010
Last Update Posted: December 7, 2010
Last Verified: December 2010

Keywords provided by Taipei Medical University WanFang Hospital:
obesity
body composition
adipocyte-derived cytokine
low glycemic index