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Sponsor decided to withdraw from study.
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| Name | Class |
|---|---|
| InterHealth Nutraceuticals, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the effects of a combination of hydroxcycitrate (HCA) and niacin-bound chromium, in conjunction with nutrition education, over a twelve week period. Participants will be evaluated with regard to BMI, percent body fat, insulin activity, and hunger.
The prevalence of obesity among youth has increased dramatically in recent years. Parallel to the increased rates of pediatric obesity, overweight children present clinically with adiposity related comorbidities such as insulin resistance and type 2 diabetes. The prevailing recommendations for overweight youth are to increase physical activity levels and limit energy intake in order to improve body composition. Currently there is little empirical evidence to support the efficacy of these recommendations. Alternatively, evidence in adults suggests that nutritional supplementation with (-) hydroxycitric acid (HCA), an organic acid found naturally in citrus fruits, and chromium may lead to favorable changes in body composition and improve glucose regulation. To date, these issues have not been tested in youth. Therefore, the purpose of the present investigation is to examine the effects of a nutritional education program combined with either HCA + chromium or placebo on measures of body composition and glucose regulation in overweight adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - nutrition education plus active supplement | Active Comparator | nutrition education plus active supplement |
|
| 2 - nutrition education plus inactive supplement | Placebo Comparator | nutrition education plus inactive supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutrition education plus active supplement | Drug | After all baseline measures have been completed, participants will be randomly assigned to either the nutrition education + supplement group, or the nutrition education + placebo group. The length of the intervention is twelve weeks. Nutrition classes will take place once a week for 1 1/2 hours. Subjects will be encouraged to increase fiber and decrease sugar intake. They will also be separated into gender-specific classes. Active and inactive supplements will be identical in appearance and taste. Active supplements will contain 2,700 mgs/day of Super CitriMax (hydroxycitrate)and 400 µg per day of ChromeMate (niacin-bound Chromium). Supplements will be in powder and tablet form, and should be taken 30 minutes prior to each meal. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Change in Body Mass Index measurement at baseline and 12 weeks | measured at baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Activity | Change in insulin activity measured at baseline and 12 weeks | Measured at baseline and 12 weeks |
| Percent Body Fat | Change in percent body fat measured at baseline and 12 weeks |
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Inclusion Criteria:
Age
Overweight
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael I Goran, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC - Preventive Medicine | Los Angeles | California | 90033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | nutrition education plus active supplement |
| FG001 | Control Arm | nutrition education plus inactive supplement |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | nutrition education plus active supplement |
| BG001 | Control Arm | nutrition education plus inactive supplement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Mass Index | Change in Body Mass Index measurement at baseline and 12 weeks | Data were not collected. Previously reported data were incorrect and do not reflect a change in BMI from baseline to 12 weeks. Only basic demographic information was collected at baseline and no outcome measures were captured. The study was terminated prior to the 12 week intervention end and no data were collected at the second time point. | Posted | measured at baseline and 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm | nutrition education plus active supplement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Goran | USC | 323.442.3027 | goran@usc.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
|
| nutrition education plus inactive supplement | Drug | After all baseline measures have been completed, participants will be randomly assigned to either the nutrition education + supplement group, or the nutrition education + placebo group. The length of the intervention is twelve weeks. Nutrition classes will take place once a week for 1 1/2 hours. Subjects will be encouraged to increase fiber and decrease sugar intake. They will also be separated into gender-specific classes. Active and inactive supplements will be identical in appearance and taste. |
|
|
| Measured at baseline and 12 weeks |
| Hunger | Change in hunger score using Likert scale measured at baseline and 12 weeks | Measured at baseline and 12 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Insulin Activity | Change in insulin activity measured at baseline and 12 weeks | Data were not collected | Posted | Measured at baseline and 12 weeks |
|
|
| Secondary | Percent Body Fat | Change in percent body fat measured at baseline and 12 weeks | Data were not collected | Posted | Measured at baseline and 12 weeks |
|
|
| Secondary | Hunger | Change in hunger score using Likert scale measured at baseline and 12 weeks | Data were not collected | Posted | Measured at baseline and 12 weeks |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Control Arm | nutrition education plus inactive supplement | 0 | 4 | 0 | 4 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |