Garcinia Mangostana Extracts in the Management of Weight Loss

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University of Roma La Sapienza

ESSAI CLINIQUE: NCT02823561

BioSeek: NCT02823561

Mots clés

Abstrait

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.

La 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.

Rendez-vous

Dernière vérification:	05/31/2016
Première soumission:	06/22/2016
Inscription estimée soumise:	06/29/2016
Première publication:	07/05/2016
Dernière mise à jour soumise:	08/29/2016
Dernière mise à jour publiée:	08/30/2016
Date de début réelle de l'étude:	10/31/2015
Date d'achèvement primaire estimée:	04/30/2016
Date estimée d'achèvement de l'étude:	04/30/2016

Condition ou maladie

Severe Obesity

Intervention / traitement

Dietary Supplement: Garcinia mangostana (treatment group)

Behavioral: Control group

Phase

Phase 4

Groupes d'armes

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

Critère d'éligibilité

Âges éligibles aux études	18 Years À 18 Years
Sexes éligibles à l'étude	All
Accepte les bénévoles en santé	Oui
Critères	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

Résultat

Mesures des résultats primaires

1. Weight loss - Kg reduction [26 weeks]

Mesures des résultats secondaires

1. Insulin sensitivity assessed by the homeostatic model assessment (HOMA-IR) [26 weeks]

2. Lipid profile by serum biochemistry [26 weeks]

3. Abdominal obesity measured by waist circumference [26 weeks]

4. Body composition by Dexa parameters [26 weeks]

5. Changes in microalbuminuria by unin analysis [26 weeks]

Garcinia Mangostana Extracts in the Management of Weight Loss

Mots clés

neoplasms

inflammation

obésité

mangoustanier

garcinia

sphaeranthus

sphaeranthus indicus

antioxydant

perte de poids