Garcinia Mangostana Extracts in the Management of Weight Loss
Primary Purpose
Severe Obesity
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Garcinia mangostana
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Severe Obesity
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Garcinia mangostana (treatment group)
Control group
Arm Description
Balanced low-calorie diet and regular exercise in combination with integration
balanced low-calorie diet and regular exercise
Outcomes
Primary Outcome Measures
Weight loss - Kg reduction
Secondary Outcome Measures
Insulin sensitivity assessed by the homeostatic model assessment (HOMA-IR)
Lipid profile by serum biochemistry
Abdominal obesity measured by waist circumference
Body composition by Dexa parameters
Changes in microalbuminuria by unin analysis
Full Information
NCT ID
NCT02823561
First Posted
June 23, 2016
Last Updated
August 30, 2016
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT02823561
Brief Title
Garcinia Mangostana Extracts in the Management of Weight Loss
Official Title
Efficacy and Tolerability of Garcinia Mangostana Extracts in the Management of Weight Loss in Severe Obese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Garcinia mangostana (treatment group)
Arm Type
Active Comparator
Arm Description
Balanced low-calorie diet and regular exercise in combination with integration
Arm Title
Control group
Arm Type
Other
Arm Description
balanced low-calorie diet and regular exercise
Intervention Type
Dietary Supplement
Intervention Name(s)
Garcinia mangostana
Intervention Type
Behavioral
Intervention Name(s)
Control group
Primary Outcome Measure Information:
Title
Weight loss - Kg reduction
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Insulin sensitivity assessed by the homeostatic model assessment (HOMA-IR)
Time Frame
26 weeks
Title
Lipid profile by serum biochemistry
Time Frame
26 weeks
Title
Abdominal obesity measured by waist circumference
Time Frame
26 weeks
Title
Body composition by Dexa parameters
Time Frame
26 weeks
Title
Changes in microalbuminuria by unin analysis
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Garcinia Mangostana Extracts in the Management of Weight Loss
We'll reach out to this number within 24 hrs