Diabetes Mellitus, Type 2, Obesity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
DRUGnutrition education plus inactive supplement
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.
Sponsors
InterHealth Nutraceuticals, Inc.
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Age * All subjects will be between 13 and 17 years of age * Overweight * All subjects will be overweight as defined by an age & sex-specific body mass index ≥ 85th percentile based on CDC BMI growth charts \[US Department of Health and Human Services, 2000\], calculated by Epi Info Software, version 3.3.
Exclusion criteria
* Presently taking any prescribed medication(s) or diagnosed with any syndrome or disease that could influence dietary intake, body composition and fat distribution, or insulin action or secretion. * Previously diagnosed with any major illness since birth (e.g. sever intrauterine growth retardation, chronic birth asphyxia, cancer). * Children with type 1 and/or type 2 diabetes will be excluded are referred to a physician. * Currently involved with any dietary, exercise, or weight loss program or have been in the 6 months prior to participation. * Unexplained weight loss or gain in the prior six months. * Oral contraception use in sexually active females * Children who live further than 20 miles away from the USC Health Science Campus (HSC).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | measured at baseline and 12 weeks | Change in Body Mass Index measurement at baseline and 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Activity | Measured at baseline and 12 weeks | Change in insulin activity measured at baseline and 12 weeks |
| Percent Body Fat | Measured at baseline and 12 weeks | Change in percent body fat measured at baseline and 12 weeks |
| Hunger | Measured at baseline and 12 weeks | Change in hunger score using Likert scale measured at baseline and 12 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm nutrition education plus active supplement | 4 |
| Control Arm nutrition education plus inactive supplement | 2 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated by sponsor | 4 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 15 years STANDARD_DEVIATION 1.41 | 14 years STANDARD_DEVIATION 1 | 14.6 years STANDARD_DEVIATION 1.37 |
| Age, Customized <=18 years | 4 participants | 2 participants | 6 participants |
| Region of Enrollment United States | 4 participants | 2 participants | 6 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
Primary
Body Mass Index
Change in Body Mass Index measurement at baseline and 12 weeks
Time frame: measured at baseline and 12 weeks
Population: 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.
Secondary
Hunger
Change in hunger score using Likert scale measured at baseline and 12 weeks
Time frame: Measured at baseline and 12 weeks
Population: Data were not collected
Secondary
Insulin Activity
Change in insulin activity measured at baseline and 12 weeks
Time frame: Measured at baseline and 12 weeks
Population: Data were not collected
Secondary
Percent Body Fat
Change in percent body fat measured at baseline and 12 weeks
Time frame: Measured at baseline and 12 weeks
Population: Data were not collected