ObesityNCT01255228
Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese Women
A study testing Low glycemic index diet in people with Obesity, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Low glycemic index diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI above 24 kg/m2, or the either one ( fat mass ≧ 30% or waistline > 80 cm )
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- Low glycemic index diet
- Keywords
- obesity, body composition, adipocyte-derived cytokine, low glycemic index
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic index dietOther
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Low glycemic index diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of body composition ( body weight,body mass,waist and hip circumferences )
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jen-Fang Liu, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255228
- Sponsor's protocol ID
- 99055
- Status last verified
- Dec 2010
- First submitted
- 18 Nov 2010
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese
- ClinicalTrials.gov ID
- NCT01255228
- Acronym / sponsor ID
- 99055
- Conditions
- Obesity
- Keywords
- obesity, body composition, adipocyte-derived cytokine, low glycemic index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 7 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low glycemic index diet | Experimental | Other: Low glycemic index dietThe study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women |
| diet intervention | Experimental | Other: Low glycemic index dietThe study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI above 24 kg/m2, or the either one ( fat mass ≧ 30% or waistline > 80 cm )
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low glycemic index dietThe 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 |
Primary outcome
the effect of body composition ( body weight,body mass,waist and hip circumferences )
Time frame: 6 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jen-Fang Liu principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low glycemic index diet in people with Obesity, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect of body composition ( body weight,body mass,waist and hip circumferences ) (time frame: 6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2010.