NCT02823561

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
Last Updated

August 31, 2016

Status Verified

June 1, 2016

Enrollment Period

6 months

First QC Date

June 23, 2016

Last Update Submit

August 30, 2016

Conditions

Severe Obesity

Outcome Measures

Primary Outcomes (1)

  • Weight loss - Kg reduction

    26 weeks

Secondary Outcomes (5)

  • Insulin sensitivity assessed by the homeostatic model assessment (HOMA-IR)

    26 weeks

  • Lipid profile by serum biochemistry

    26 weeks

  • Abdominal obesity measured by waist circumference

    26 weeks

  • Body composition by Dexa parameters

    26 weeks

  • Changes in microalbuminuria by unin analysis

    26 weeks

Study Arms (2)

Garcinia mangostana (treatment group)

ACTIVE COMPARATOR

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

Dietary Supplement: Garcinia mangostana

Control group

OTHER

balanced low-calorie diet and regular exercise

Behavioral: Control group

Interventions

Garcinia mangostanaDIETARY_SUPPLEMENT
Garcinia mangostana (treatment group)
Control groupBEHAVIORAL
Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obesity: BMI \>35 kg/m2.
  • Stable medical therapy for comorbidities from at least 6 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Control Groups

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 23, 2016

First Posted

July 6, 2016

Study Start

November 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

August 31, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share