Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/09/2017
Date assigned
19/09/2017
Last edited
19/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Overweight and obesity are considered major health problems that contribute to increase mortality (death) and quality of life. Both conditions have a high prevalence across the world reaching epidemic (widespread) numbers. Weight loss supplements are becoming popular as a weight to lose fat. Garcinia cambogia (GC) is a fruit that has an ingredient that is rumored to help with weight loss. Glucomannan (GNN) is an ingredient derived from a plant that is marketed for weight loss. The aim of this study is to evaluate the effects of the administration of Garcinia cambogia (GC) and Glucomannan (GNN) on long-term weight loss in people with overweight or obesity.

Who can participate?
Adults aged 18 and older who are overweight.

What does the study involve?
Participants are told to keep a balanced diet, eat regular meals and drink plenty of water. Participants are told to ingest capsules of GC and capsules of GNN twice a day, half an hour before lunch and dinner for six months. Participants are told to exercise, avoid smoking and control their alcohol intake.

What are the possible benefits and risks of participating?
Participants may benefit from weight loss. There are no risks with participating.

Where is the study run from?
1. Scientifics Aesthetics Clinics of the body Córdoba (Spain)
2. Hospital e Maternidade São Francisco de Assis (Brazil)

When is the study starting and how long is it expected to run for?
February 2015 to March 2017

Who is funding the study?
University of Córdoba (Spain)

Who is the main contact?
Professor José Lancho

Trial website

Contact information

Type

Scientific

Primary contact

Prof José Lancho

ORCID ID

http://orcid.org/0000-0002-2163-3304

Contact details

Department of Morphological Sciences
School of Medicine
University of Córdoba
Avenida de Menéndez Pidal s/n
Córdoba
14071
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GC/GNN1

Study information

Scientific title

Long-term effects of Garcinia cambogia/Glucomannan on weight loss in people with obesity, PLIN4, FTO and Trp64Arg polymorphisms

Acronym

Study hypothesis

The aim of this study is to assess whether a controlled diet supplemented with GC and GNN was able to reduce weight after 3 and 6 moths in people with overweight or obesity. Another aim of this study is to evaluate if this reduction was modified by the presence in the patients of different genetic polymorphism related to FTO (rs9939609 A/T), PLIN4 (11482G>A) and ADRB3Trp64Arg.

Ethics approval

1. Ethical Boards of Hospital Universitario Reina Sofia de Córdoba (Spain), 14/09/2014
2. Hospital e Maternidade São Francisco de Assis, Crato (Brasil), 21/01/2015

Study design

Multicentric, non randomized prospective trial, evaluating differences between two dependent means (matches pairs design)

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

No participant information sheet available

Condition

Obesity/overweight

Intervention

Participants are advised to have a balanced diet (Mediterranean diet), regular meals and intake of plenty of water. Standardised extracts of Garciania cambogia (52.4% Hydroxycitric acid) and Amorphophallus konjac (94.9%, Glucomannan) are administered separately in capsules of 500 mg each. Participants are treated with GC (500 mg), twice a day, half an hour before lunch and dinner and GNN (500 mg), twice a day, half an hour before lunch and dinner for 6 months. It was recommended to patients to practice physical exercise, avoid smoking, and control alcohol intake.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Weight is measured using digital balance (HD-305 TanitaTM) to the nearest 0.1 kg at baseline, three and six months of treatment
2. Fat mass is measured using a BioScan Spectrum operating at 50 KHz at baseline, three and six months of treatment
3. Visceral Fat mass is measured using the BioScan Spectrum operating at 50 KHz at baseline, three and six months of treatment
4. Glucose (mg/dl) is measured from blood samples using a colorimetric enzyme assay method (CEPA® kits – MBiolog Diagnósticos Ltda.) at baseline, three and six months of treatment
5. Tryglerides (mg/dl) is measured from blood samples using using a colorimetric enzyme assay method (CEPA® kits – MBiolog Diagnósticos Ltda.) at baseline, three and six months of treatment
6. Cholesterol (mg/dl) is measured from blood samples using a colorimetric enzyme assay method (CEPA® kits – MBiolog Diagnósticos Ltda.) at baseline, three and six months of treatment

Secondary outcome measures

Interaction of different polymorphism with primary outcome measures is measured using analysis of covariance or correlation through Pearson correlation test (for continuous variable such as age) at baseline, three and six months of treatment.

Overall trial start date

08/02/2015

Overall trial end date

08/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males and females
2. Aged 18 years old
3. Have an BMC>25 and could be suffering dyslipidemias, hypertension, DM2 or their combinations

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

214

Participant exclusion criteria

1. Pregnancy or lactation
2. Gastroplasty or gastrointestinal weight-reducing surgery
3. Stopped smoking during the past 6 months
4. Kidney disease
5. History of recurrent kidney stones
6. Liver dysfunction
7. Untreated high blood pressure
8. History or symptoms of gallstones
9. Cancer
10. History of endocrine disorders (particularly hypothyroidism)
11. History of bulimia and/or laxative abuse
12. Mental disorders with impaired independence
13. History of alcohol or other drug abuse

Recruitment start date

12/02/2015

Recruitment end date

08/03/2015

Locations

Countries of recruitment

Brazil, Spain

Trial participating centre

Scientifics Aesthetics Clinics of the body from Córdoba
Córdoba
14071
Spain

Trial participating centre

Hospital e Maternidade São Francisco de Assis
Crato
63105
Brazil

Sponsor information

Organisation

University of Córdoba

Sponsor details

Department of Morphological Sciences
School of Medicine
Avenida de Menéndez Pidal s/n 14071
Córdoba
14071
Spain

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

University of Córdoba

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned submission to peer review evaluation to BMC alternative and complementary medicine.

IPD sharing statement:
Data related to this study are stored in Department of Morphological Sciences, School of Medicine, University of Córdoba, Spain. Mailing address: Avenida de Menéndez Pidal s/n 14071 Córdoba, Spain. Phone: +34 957218256.

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. Prof, José L. Lancho at Department of Morphological Sciences, School of Medicine, University of Córdoba, Spain. Mailing address: Avenida de Menéndez Pidal s/n 14071 Córdoba, Spain. Phone: +34 957218256

All patients were informed and signed the proper informed consent. This work was in accordance with Helsinki declaration. Participant information was encrypted assigning different numbers to each participant. Participant personal information is protected by spanish law (Ley Orgánica 15/1999, de 13 de diciembre, de Protección de Datos de Carácter Personal)

Intention to publish date

13/09/2017

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes