Garcinia Mangostana Extracts in the Management of Weight Loss

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StatussPabeigts

Sponsori

University of Roma La Sapienza

KLĪNISKĀ IZPĒTE: NCT02823561

BioSeek: NCT02823561

Atslēgvārdi

Abstrakts

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.

Apraksts

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.

Datumi

Pēdējoreiz pārbaudīts:	05/31/2016
Pirmais iesniegtais:	06/22/2016
Paredzētā reģistrācija iesniegta:	06/29/2016
Pirmais izlikts:	07/05/2016
Pēdējais atjauninājums iesniegts:	08/29/2016
Pēdējā atjaunināšana ievietota:	08/30/2016
Faktiskais studiju sākuma datums:	10/31/2015
Paredzamais primārās pabeigšanas datums:	04/30/2016
Paredzamais pētījuma pabeigšanas datums:	04/30/2016

Stāvoklis vai slimība

Severe Obesity

Iejaukšanās / ārstēšana

Dietary Supplement: Garcinia mangostana (treatment group)

Behavioral: Control group

Fāze

Fāze 4

Roku grupas

Roka	Iejaukšanās / ārstēšana
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

Atbilstības kritēriji

Vecums, kas piemērots studijām	18 Years Uz 18 Years
Dzimumi, kas ir piemēroti studijām	All
Pieņem veselīgus brīvprātīgos	Jā
Kritēriji	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

Rezultāts

Primārie rezultāti

1. Weight loss - Kg reduction [26 weeks]

Sekundārie iznākuma mērījumi

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

Atslēgvārdi

vēzis

iekaisums

aptaukošanās

mangostāns

garcinia

sphaeranthus

sphaeranthus indicus

antioksidants

svara zudums