Garcinia Mangostana Extracts in the Management of Weight Loss
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02823561|
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : August 31, 2016
Obesity is one of the greatest public health challenges of the 21st century. Its prevalence has tripled in many countries of the European Region since the 1980s, and the numbers of those affected continue to rise at an alarming rate. In addition to causing various physical disabilities and psychological problems, excess weight drastically increases a person's risk of developing a number of noncommunicable diseases including cardiovascular disease, cancer and diabetes, in association or not to metabolic syndrome. The risk of developing more than one of these diseases (co-morbidity) also increases with increasing body weight. Every year a growing number of patient tend to suffer of more severe obesity and difficulty in losing weight even with a restricted diet and exercise.
Garcinia mangostana (Sphaeranthus indicus extract) has known for its antioxidant properties; new evidence point out some promising effects in the prevention of lipogenesis and the promotion of lipolysis . Currently in the scientific literature there is only one paper, by Stern et al., showing the association of Garcinia mangostana assumption in low-calorie diet. This work has demonstrated a significant reduction in weight loss , compared to the placebo group,due to the use of Garcinia mangostana.
Aim of the present study is the evaluation of safety and efficacy of weight loss in severe obese patients. Also cardiometabolic parameters and flogosys serum indicators will be evaluated before and after 6 month therapy of low calory diet alone or in association with Garcinia mangostana extract.
|Condition or disease||Intervention/treatment||Phase|
|Severe Obesity||Dietary Supplement: Garcinia mangostana Behavioral: Control group||Phase 4|
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:
- low-calorie balanced diet consistent exercise (control group)
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Tolerability of Garcinia Mangostana Extracts in the Management of Weight Loss in Severe Obese Patients|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Active Comparator: Garcinia mangostana (treatment group)
Balanced low-calorie diet and regular exercise in combination with integration
Dietary Supplement: Garcinia mangostana
balanced low-calorie diet and regular exercise
Behavioral: Control group
- Weight loss - Kg reduction [ Time Frame: 26 weeks ]
- Insulin sensitivity assessed by the homeostatic model assessment (HOMA-IR) [ Time Frame: 26 weeks ]
- Lipid profile by serum biochemistry [ Time Frame: 26 weeks ]
- Abdominal obesity measured by waist circumference [ Time Frame: 26 weeks ]
- Body composition by Dexa parameters [ Time Frame: 26 weeks ]
- Changes in microalbuminuria by unin analysis [ Time Frame: 26 weeks ]