Severe Obesity Clinical Trial
Official title:
Efficacy and Tolerability of Garcinia Mangostana Extracts in the Management of Weight Loss in Severe Obese Patients
Verified date | June 2016 |
Source | University of Roma La Sapienza |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight loss - Kg reduction | 26 weeks | No | |
Secondary | Insulin sensitivity assessed by the homeostatic model assessment (HOMA-IR) | 26 weeks | No | |
Secondary | Lipid profile by serum biochemistry | 26 weeks | No | |
Secondary | Abdominal obesity measured by waist circumference | 26 weeks | No | |
Secondary | Body composition by Dexa parameters | 26 weeks | No | |
Secondary | Changes in microalbuminuria by unin analysis | 26 weeks | No |
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