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Garcinia Mangostana Extracts in the Management of Weight Loss

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ClinicalTrials.gov Identifier: NCT02823561
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
Carla Lubrano, University of Roma La Sapienza

Study Description
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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.


Condition or disease Intervention/treatment Phase
Severe Obesity Dietary Supplement: Garcinia mangostana Behavioral: Control group Phase 4

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:

  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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Garcinia mangostana (treatment group)
Balanced low-calorie diet and regular exercise in combination with integration
 Dietary Supplement: Garcinia mangostana
Control group
balanced low-calorie diet and regular exercise
 Behavioral: Control group


Outcome Measures
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Primary Outcome Measures :
  1. Weight loss - Kg reduction [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Insulin sensitivity assessed by the homeostatic model assessment (HOMA-IR) [ Time Frame: 26 weeks ]
  2. Lipid profile by serum biochemistry [ Time Frame: 26 weeks ]
  3. Abdominal obesity measured by waist circumference [ Time Frame: 26 weeks ]
  4. Body composition by Dexa parameters [ Time Frame: 26 weeks ]
  5. Changes in microalbuminuria by unin analysis [ Time Frame: 26 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Carla Lubrano, Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02823561    
Other Study ID Numbers: URomLS-01
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Obesity, Morbid
Weight Loss
Body Weight Changes
Body Weight
 Obesity
Overnutrition
Nutrition Disorders
Overweight