Supplements for Controlling Resistance to Insulin
Ключові слова
Анотація
Опис
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.
Дати
| Востаннє перевірено: | 04/30/2019 |
| Перший поданий: | 06/15/2008 |
| Орієнтовна реєстрація подана: | 06/16/2008 |
| Опубліковано вперше: | 06/17/2008 |
| Останнє оновлення надіслано: | 05/30/2019 |
| Останнє оновлення опубліковано: | 06/24/2019 |
| Дата першого подання результатів: | 09/22/2011 |
| Дата першого подання результатів контролю якості: | 03/28/2017 |
| Дата першого розміщення результатів: | 05/10/2017 |
| Фактична дата початку навчання: | 01/31/2008 |
| Розрахункова дата первинного завершення: | 07/31/2008 |
| Розрахункова дата завершення дослідження: | 07/31/2008 |
Стан або захворювання
Втручання / лікування
Drug: 1 - nutrition education plus active supplement
Drug: 2 - nutrition education plus inactive supplement
Фаза
Групи рук
| Рука | Втручання / лікування |
|---|---|
| Active Comparator: 1 - nutrition education plus active supplement nutrition education plus active supplement | Drug: 1 - nutrition education plus active 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. 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. |
| Placebo Comparator: 2 - nutrition education plus inactive supplement nutrition education plus inactive supplement | Drug: 2 - nutrition 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. |
Критерії прийнятності
| Вік, придатний для навчання | 13 Years До 13 Years |
| Стать, яка підходить для вивчення | All |
| Приймає здорових добровольців | Так |
| Критерії | 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). |
Результат
Заходи первинного результату
1. Body Mass Index [measured at baseline and 12 weeks]
Заходи вторинного результату
1. Insulin Activity [Measured at baseline and 12 weeks]
2. Percent Body Fat [Measured at baseline and 12 weeks]
3. Hunger [Measured at baseline and 12 weeks]
