Garcinia Mangostana Extracts in the Management of Weight Loss
关键词
抽象
描述
After the screening visit for the evaluation of the inclusion / exclusion criteria and sign informed consent(Visit 1), each patient will be randomized (Visit 2; Time 0; Baseline) (1: 1) to receive two different treatment for the duration of 26 weeks:
1. low-calorie balanced diet consistent exercise (control group)
2. balanced low-calorie diet and regular exercise in combination with the assumption of Garcinia mangostana (treatment group)
Throughout the duration of the study, every eight weeks, unless otherwise indicated from the specialists, for each subject was expected a nutritional and an endocrinological visit with a anthropometric parameter check (body composition) and compliance to therapy (dietary / physical activity diary).
Also a bood sample test was performed to evaluate electrocardiogram, lipid profile, glucose tolerance, hormonal parameters, inflammatory and bone markers.
日期
| 最后验证: | 05/31/2016 |
| 首次提交: | 06/22/2016 |
| 提交的预估入学人数: | 06/29/2016 |
| 首次发布: | 07/05/2016 |
| 上次提交的更新: | 08/29/2016 |
| 最近更新发布: | 08/30/2016 |
| 实际学习开始日期: | 10/31/2015 |
| 预计主要完成日期: | 04/30/2016 |
| 预计完成日期: | 04/30/2016 |
状况或疾病
干预/治疗
Dietary Supplement: Garcinia mangostana (treatment group)
Behavioral: Control group
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Garcinia mangostana (treatment group) Balanced low-calorie diet and regular exercise in combination with integration | Dietary Supplement: Garcinia mangostana (treatment group) |
| Other: Control group balanced low-calorie diet and regular exercise | Behavioral: Control group |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Obesity: BMI >35 kg/m2. - Stable medical therapy for comorbidities from at least 6 months Exclusion Criteria: - Hormonal replacement therapy - Hyperprolactinaemia and /or other endocrine hypothalamic-pituitary diseases (empty sella syndrome and expansive pituitary disorders evaluated by MRI) - Any other condition that medical judgment precludes patient safety |
结果
主要结果指标
1. Weight loss - Kg reduction [26 weeks]
次要成果指标
1. Insulin sensitivity assessed by the homeostatic model assessment (HOMA-IR) [26 weeks]
2. Lipid profile by serum biochemistry [26 weeks]
3. Abdominal obesity measured by waist circumference [26 weeks]
4. Body composition by Dexa parameters [26 weeks]
5. Changes in microalbuminuria by unin analysis [26 weeks]
