Garcinia Mangostana Extracts in the Management of Weight Loss

Efficacy and Tolerability of Garcinia Mangostana Extracts in the Management of Weight Loss in Severe Obese Patients

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.

Study Overview

• Status: Completed
• Conditions: Severe Obesity
• Intervention / Treatment: Dietary supplement: Garcinia mangostana; Behavioral: Control group

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: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Garcinia mangostana (treatment group); Balanced low-calorie diet and regular exercise in combination with integration	Dietary supplement: Garcinia mangostana
OTHER: Control group; balanced low-calorie diet and regular exercise	Behavioral: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight loss - Kg reduction	26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Insulin sensitivity assessed by the homeostatic model assessment (HOMA-IR)	26 weeks
Lipid profile by serum biochemistry	26 weeks
Abdominal obesity measured by waist circumference	26 weeks
Body composition by Dexa parameters	26 weeks
Changes in microalbuminuria by unin analysis	26 weeks

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (ESTIMATE): July 6, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 31, 2016
• Last Update Submitted That Met QC Criteria: August 30, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss; Obesity, Morbid
• Other Study ID Numbers: URomLS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO