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Garcinia Mangostana Extracts in the Management of Weight Loss

NCT ID: NCT02823561

Last Updated: 2016-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Severe Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Garcinia mangostana (treatment group)

Balanced low-calorie diet and regular exercise in combination with integration

Group Type ACTIVE_COMPARATOR

Garcinia mangostana

Intervention Type DIETARY_SUPPLEMENT

Control group

balanced low-calorie diet and regular exercise

Group Type OTHER

Control group

Intervention Type BEHAVIORAL

Interventions

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Garcinia mangostana

Intervention Type DIETARY_SUPPLEMENT

Control group

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Carla Lubrano

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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URomLS-01

Identifier Type: -

Identifier Source: org_study_id