NCT01255228

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2010

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 7, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

December 7, 2010

Status Verified

December 1, 2010

Enrollment Period

9 months

First QC Date

November 18, 2010

Last Update Submit

December 5, 2010

Conditions

Keywords

obesitybody compositionadipocyte-derived cytokinelow glycemic index

Outcome Measures

Primary Outcomes (1)

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

    6 week

Study Arms (2)

Low glycemic index diet

EXPERIMENTAL

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

diet intervention

EXPERIMENTAL

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

Interventions

The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women

Low glycemic index dietdiet intervention

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI above 24 kg/m2, or the either one ( fat mass ≧ 30% or waistline \> 80 cm )

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jen-Fang Liu

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2010

First Posted

December 7, 2010

Study Start

May 1, 2010

Primary Completion

February 1, 2011

Study Completion

April 1, 2011

Last Updated

December 7, 2010

Record last verified: 2010-12

Locations