OverweightEarly Phase 1NCT00603655
Effect of Glycemic Load on Body Composition
A Early Phase 1 study testing Low glycemic load diet and High glycemic load diet in people with Overweight and Obesity, run by Universidad Autonoma de Baja California at 1 site in Mexico.
Trial summary
The aim of this study is to compare the effects of diets with different glycemic load (GL) on body composition and biochemical markers in overweight and obese subjects during a 12-month period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Low glycemic load diet and High glycemic load diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2007to Dec 2008
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight or obese adults
Who cannot join
- Subjects who are pregnant or have diabetes, cancer, psychiatric disorders or physical disabilities
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Facultad de Medicina y Psicología
Tijuana, Estado de Baja California, 22390
About this study
Official title: Assessment of Glycemic Load on Body Composition Among Overweight and Obese Adults During 12 Month Period
The aim of this study is to compare the effects of diets with different glycemic load (GL) on body composition and biochemical markers in overweight and obese subjects during a 12-month period.
Read the detailed description
Study Procedure:
The study is a randomized, experimental, parallel design conducted in a group of Mexican subjects during a 6-month period. Anthropometric and biochemical data will be determined at 0, 3, 6, 9 and 12 months.
Subjects:
Overweight or obese adults were assigned into two groups: LGL diet and HGL diet. Subjects who were pregnant or had diabetes, cancer, psychiatric disorders or physical disabilities were excluded.
Diets and Dietary Assessment:
Two diets were designed including LGL and HGL diets. GI values of each food were estimated from the tables by Foster-Powell et al. Daily GL was determined by the product of total dietary carbohydrate (grams) and GI of each food and adjusted to energetic intake using the following formulas: GI = Σ (GI of each food X proportion of total carbohydrate contributed from each food); GL= Σ (GI of each food × grams of total carbohydrate from each food)/1000 kcal.
Diets were designed according to the food habits of Mexicans living in the Tijuana area. On the first day, subjects received different menus of either LGL or HGL diets, according to the randomization. A research assistant was available by mail or by phone for questions during the 6-month period. An e-mail, as a reminder and reinforcement to maintain the diet, was sent every 2 weeks to all participants. Subjects who completed the 3-day dietary record (two weekdays and one weekend day) were included in the analysis.
Anthropometric Measurements:
Height was measured to the nearest millimeter using a portable stadiometer (model 214 Road Rod, Seca Corp., Hanover, MD). Weight was measured to the nearest 0.1 kg using an electronic scale (Bod Pod, Life Measurement Inc., Concord, CA). Subjects were dressed in light clothing and were not wearing shoes. Body mass index (BMI) was calculated using the following formula: weight (kg)/height (m2). Waist circumference (WC) was measured at the minimum circumference between the iliac crest and the rib cage. Fat mass (in kg) and total body fat percentage were measured by plethysmography with the Bod Pod. The subjects entered the Bod Pod wearing a bodysuit and Lycra hat.
Blood Analysis:
Venous blood samples were taken at 8 AM from an antecubital vein after a 12-hour overnight fast, again at baseline and at 3 months after beginning the study. Blood samples were centrifuged at 3500 × g for 3 minutes, and plasma was removed and analyzed immediately after collection. For quantitative determination of glucose in serum, the glucose oxidase procedure based on a modified Trinder method was used (SERA-PAK Plus, Bayer, Sées, France). Serum insulin levels were determined by chemiluminescent immunoassay by the IMMULITE 2000 analyzer (Diagnostic Products Corporation, Los Angeles, CA). Homeostasis model assessment (HOMA) was used to estimate insulin resistance and was computed as follows: (fasting serum insulin [μU/ml] × fasting plasma glucose [mmol/L]/22.5). Total cholesterol, HDL-cholesterol and triglycerides were measured by enzymatic methods (SERA-PAK Plus); LDL-cholesterol was calculated using the Friedwald formula: LDL (mmol/L) = total cholesterol - (TG/2.2) - HDL.
Physical Activity Assessment:
A questionnaire containing seven questions from the International Physical Activity Questionnaire (IPAQ) was used to evaluate physical activity at baseline and at 1, 3 and 6 months after study initiation.
Statistical Analysis:
Mean ± standard deviations were calculated using descriptive statistics in all variables. Anthropometric measurements were evaluated, and it was determined that they did not meet the normality test (Kolmogorov-Smirnov and Shapiro-Wilk). To test differences between groups on biochemical and anthropometric measurements, Mann-Whitney non-parametric test for independent samples was performed. For comparison of differences before, at 3 and 6 months after intervention in the same treatment group, we used Friedman non-parametric test for repeated measurements. To test differences between groups on diet intake at baseline and at the end of the study, Mann-Whitney non-parametric test for independent samples was performed.
- Conditions
- Overweight, Obesity
- Being tested
- Low glycemic load diet, High glycemic load diet
- Keywords
- Diet, glycemic load, overweight, obesity, hyperlipidemia
- Medical subject headings
- Overweight, Obesity, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic load dietOther
Also called Low glycemic index
Low glycemic load diet
High glycemic load dietOther
High glycemic load diet
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | This group will receive a low glycemic load Receives: Other: Low glycemic load diet |
| B | Active comparator | This group will receive a high glycemic load Receives: Other: High glycemic load diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of body fat percentage
Measured: 3, 6, 9 and 12 months
Secondary outcomes (1)
Reduction of homeostasis model assessment (HOMA)
Measured: 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Why it stopped: Higher drop out than expected. Lower Statistical Power.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Baja California
- Sponsor type
- University, hospital or other
- Investigators
- Arturo Jimenez-Cruz, MD, Principal investigator, Universidad Autonoma de Baja California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603655
- Sponsor's protocol ID
- UABC4268
- Other IDs
- UABC20074268
- Status last verified
- Dec 2008
- First submitted
- 16 Jan 2008
- Last updated
- 31 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Glycemic Load on Body Composition Among Overweight and Obese Adults During 12 Month Period
- ClinicalTrials.gov ID
- NCT00603655
- Acronym / sponsor ID
- UABC4268
- Conditions
- Overweight, Obesity
- Keywords
- Diet, glycemic load, overweight, obesity, hyperlipidemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Higher drop out than expected. Lower Statistical Power.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universidad Autonoma de Baja CaliforniaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 29 Jan 2008 (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.
The aim of this study is to compare the effects of diets with different glycemic load (GL) on body composition and biochemical markers in overweight and obese subjects during a 12-month period.
Detailed description
Study Procedure:
The study is a randomized, experimental, parallel design conducted in a group of Mexican subjects during a 6-month period. Anthropometric and biochemical data will be determined at 0, 3, 6, 9 and 12 months.
Subjects:
Overweight or obese adults were assigned into two groups: LGL diet and HGL diet. Subjects who were pregnant or had diabetes, cancer, psychiatric disorders or physical disabilities were excluded.
Diets and Dietary Assessment:
Two diets were designed including LGL and HGL diets. GI values of each food were estimated from the tables by Foster-Powell et al. Daily GL was determined by the product of total dietary carbohydrate (grams) and GI of each food and adjusted to energetic intake using the following formulas: GI = Σ (GI of each food X proportion of total carbohydrate contributed from each food); GL= Σ (GI of each food × grams of total carbohydrate from each food)/1000 kcal.
Diets were designed according to the food habits of Mexicans living in the Tijuana area. On the first day, subjects received different menus of either LGL or HGL diets, according to the randomization. A research assistant was available by mail or by phone for questions during the 6-month period. An e-mail, as a reminder and reinforcement to maintain the diet, was sent every 2 weeks to all participants. Subjects who completed the 3-day dietary record (two weekdays and one weekend day) were included in the analysis.
Anthropometric Measurements:
Height was measured to the nearest millimeter using a portable stadiometer (model 214 Road Rod, Seca Corp., Hanover, MD). Weight was measured to the nearest 0.1 kg using an electronic scale (Bod Pod, Life Measurement Inc., Concord, CA). Subjects were dressed in light clothing and were not wearing shoes. Body mass index (BMI) was calculated using the following formula: weight (kg)/height (m2). Waist circumference (WC) was measured at the minimum circumference between the iliac crest and the rib cage. Fat mass (in kg) and total body fat percentage were measured by plethysmography with the Bod Pod. The subjects entered the Bod Pod wearing a bodysuit and Lycra hat.
Blood Analysis:
Venous blood samples were taken at 8 AM from an antecubital vein after a 12-hour overnight fast, again at baseline and at 3 months after beginning the study. Blood samples were centrifuged at 3500 × g for 3 minutes, and plasma was removed and analyzed immediately after collection. For quantitative determination of glucose in serum, the glucose oxidase procedure based on a modified Trinder method was used (SERA-PAK Plus, Bayer, Sées, France). Serum insulin levels were determined by chemiluminescent immunoassay by the IMMULITE 2000 analyzer (Diagnostic Products Corporation, Los Angeles, CA). Homeostasis model assessment (HOMA) was used to estimate insulin resistance and was computed as follows: (fasting serum insulin [μU/ml] × fasting plasma glucose [mmol/L]/22.5). Total cholesterol, HDL-cholesterol and triglycerides were measured by enzymatic methods (SERA-PAK Plus); LDL-cholesterol was calculated using the Friedwald formula: LDL (mmol/L) = total cholesterol - (TG/2.2) - HDL.
Physical Activity Assessment:
A questionnaire containing seven questions from the International Physical Activity Questionnaire (IPAQ) was used to evaluate physical activity at baseline and at 1, 3 and 6 months after study initiation.
Statistical Analysis:
Mean ± standard deviations were calculated using descriptive statistics in all variables. Anthropometric measurements were evaluated, and it was determined that they did not meet the normality test (Kolmogorov-Smirnov and Shapiro-Wilk). To test differences between groups on biochemical and anthropometric measurements, Mann-Whitney non-parametric test for independent samples was performed. For comparison of differences before, at 3 and 6 months after intervention in the same treatment group, we used Friedman non-parametric test for repeated measurements. To test differences between groups on diet intake at baseline and at the end of the study, Mann-Whitney non-parametric test for independent samples was performed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Low glycemic load dietThis group will receive a low glycemic load |
| B | Active comparator | Other: High glycemic load dietThis group will receive a high glycemic load |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Overweight or obese adults
Key exclusion criteria (1 listed)
- Subjects who are pregnant or have diabetes, cancer, psychiatric disorders or physical disabilities
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 load dietAlso: Low glycemic indexLow glycemic load diet | Other | A |
| High glycemic load dietHigh glycemic load diet | Other | B |
Primary outcome
Reduction of body fat percentage
Time frame: 3, 6, 9 and 12 months
1 secondary outcome
Reduction of homeostasis model assessment (HOMA)
Time frame: 3, 6, 9 and 12 months
Results and safety
The study was stopped early (reason given: Higher drop out than expected. Lower Statistical Power.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2008.
Related trials for Overweight
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Active, not recruiting
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Obesity, Weight Loss
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Not yet recruitingPhase 2
A Study to Evaluate Efficacy and Safety of BGM1812 Injection in Overweight or Obese Participants Without Diabetes
Overweight or Obese Participants Without Diabetes
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.
Arturo Jimenez-Cruz, MD principal investigator
Universidad Autonoma de Baja California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Low glycemic load diet and High glycemic load diet in people with Overweight and Obesity, run by Universidad Autonoma de Baja California at 1 site in Mexico.
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 1 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: stopped early, as of the sponsor's last update on 31 Dec 2008. 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 Mexico. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Higher drop out than expected. Lower Statistical Power.). 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?
Reduction of body fat percentage (time frame: 3, 6, 9 and 12 months). 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 31 Dec 2008.