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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
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 23, 2016
    Last Updated
    August 30, 2016
    Sponsor
    University of Roma La Sapienza
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    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

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    Garcinia Mangostana Extracts in the Management of Weight Loss

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