Garcinia Mangostana Extracts in the Management of Weight Loss
Palabras clave
Abstracto
Descripción
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.
fechas
Verificado por última vez: | 05/31/2016 |
Primero enviado: | 06/22/2016 |
Inscripción estimada enviada: | 06/29/2016 |
Publicado por primera vez: | 07/05/2016 |
Última actualización enviada: | 08/29/2016 |
Última actualización publicada: | 08/30/2016 |
Fecha de inicio real del estudio: | 10/31/2015 |
Fecha estimada de finalización primaria: | 04/30/2016 |
Fecha estimada de finalización del estudio: | 04/30/2016 |
Condición o enfermedad
Intervención / tratamiento
Dietary Supplement: Garcinia mangostana (treatment group)
Behavioral: Control group
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
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 |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | 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 |
Salir
Medidas de resultado primarias
1. Weight loss - Kg reduction [26 weeks]
Medidas de resultado secundarias
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]