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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
Sponsor:
Information provided by (Responsible Party):
Carla Lubrano, University of Roma La Sapienza

Tracking Information
First Submitted Date  ICMJE June 23, 2016
First Posted Date  ICMJE July 6, 2016
Last Update Posted Date August 31, 2016
Study Start Date  ICMJE November 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2016)
Weight loss - Kg reduction [ Time Frame: 26 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2016)
Weight loss [ Time Frame: 26 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2016)
  • Insulin sensitivity assessed by HOMA-IR [ Time Frame: 26 weeks ]
  • Lipid profile [ Time Frame: 26 weeks ]
  • Abdominal obesity measured by waist circumference [ Time Frame: 26 weeks ]
  • Body composition [ Time Frame: 26 weeks ]
  • Changes in microalbuminuria [ Time Frame: 26 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Garcinia Mangostana Extracts in the Management of Weight Loss
Official Title  ICMJE Efficacy and Tolerability of Garcinia Mangostana Extracts in the Management of Weight Loss in Severe Obese Patients
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:

  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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Severe Obesity
Intervention  ICMJE
  • Dietary Supplement: Garcinia mangostana
  • Behavioral: Control group
Study Arms  ICMJE
  • Active Comparator: Garcinia mangostana (treatment group)
    Balanced low-calorie diet and regular exercise in combination with integration
    Intervention: Dietary Supplement: Garcinia mangostana
  • Control group
    balanced low-calorie diet and regular exercise
    Intervention: Behavioral: Control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2016)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02823561
Other Study ID Numbers  ICMJE URomLS-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carla Lubrano, University of Roma La Sapienza
Study Sponsor  ICMJE University of Roma La Sapienza
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Roma La Sapienza
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP