Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02823561
Study type Interventional
Source University of Roma La Sapienza
Contact
Status Completed
Phase Phase 4
Start date November 2015
Completion date May 2016

See also
  Status Clinical Trial Phase
Completed NCT03690752 - Adherence to Walking on an Alter G Anti-Gravity Treadmill N/A
Active, not recruiting NCT02767505 - Bypass Equipoise Sleeve Trial (BEST) N/A
Recruiting NCT05786092 - Impact of Telemonitoring on Metabolic Variables in Severe Obesity N/A
Active, not recruiting NCT03249441 - Compassion-Focused Therapy for People With Severe Obesity. N/A
Terminated NCT04626232 - Comparison of the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique in Morbidly Obese Patients N/A
Completed NCT02952963 - Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass Phase 4
Active, not recruiting NCT02374632 - Gut Hormones as Mediators of Different Weight Loss Responses After Roux-en-Y Gastric Bypass Phase 4
Active, not recruiting NCT04165694 - Single Anastomosis Duodenal Ileal Bypass (SADI) for Sleeve Revision N/A
Not yet recruiting NCT06162715 - GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Feasibility Trial Phase 2
Completed NCT05409612 - Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients Phase 3
Completed NCT03638895 - Energy Expenditure From ECAL Indirect Calorimeter in a Multicomponent Weight Management Service N/A
Not yet recruiting NCT05493592 - Pigeon Peas (Cajanus Cajan) : a Natural Anti-inflammatory Facilitating Weight Loss in Obese Patients Returning to Sport? N/A
Completed NCT02340247 - Effects of Bile Acids on GLP-1 Secretion After Roux-en-Y Gastric Bypass Phase 4
Recruiting NCT02076880 - SLEEVEDIAB To Explore the Early and Late Metabolic Effects of Sleeve Gastrectomy in Obese Patients N/A
Completed NCT04042493 - Connect for Health Pediatric Weight Management Program N/A
Completed NCT04129801 - Muscle Strength in Severe Obese Patients in the Postoperative of Bariatric Surgery
Completed NCT05341414 - Trajectories of Resilience and Bariatric Surgery Outcomes
Recruiting NCT02710786 - Comorbidity After Gastric Bypass
Recruiting NCT02409160 - Sleep and Immune Response in Severe Obese Patients Undergoing Bariatric Surgery. N/A
Completed NCT00623792 - Study on Impact of Lifestyle Change and Weight Loss Before Bariatric Surgery N/A