Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/01/2018
Date assigned
17/01/2018
Last edited
17/01/2018
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 a reduction in quality of life and increase mortality (death) risk. Both conditions have a high prevalence across the world reaching epidemic numbers. Weight loss supplements are becoming popular as a weight to lose fat. Garcinia cambogia (GC) is a fruit that has an ingredient that might incresae weight loss. Glucomannan (GNN) is an ingredient derived from a plant that is also 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 have a BMI over 25.

What does the study involve?
Participants 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 six months. Participants are assessed for their weight and fat percentage.

What are the possible benefits and risks of participating?
Participants may benefit in improvements in their condition. There are no direct risks with participating.

Where is the study run from?
Scientifics Aesthetics Clinics of the body (Spain)

When is the study starting and how long is it expected to run for?
June 2014 to October 2017

Who is funding the study?
Universidad de Córdoba (Spain)

Who is the main contact?
Professor José L Lancho (Scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Prof José L 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
Cordoba
14071
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GC/GNN-2

Study information

Scientific title

Combined treatment of Garcinia cambogia and Glucomannan reduce weight, change body composition and ameliorate lipid and glucose blood profiles of people with overweight or obesity

Acronym

Study hypothesis

Combined treatment reduces weight, changes body composition and ameliorate lipid and glucose blood profiles in overweight/obese patients.

Ethics approval

Ethical Boards of Hospital Universitario Reina Sofia de Córdoba (Spain), 14/09/2014, ref: GC/GNN-2

Study design

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 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 six months.

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

Secondary outcome measures

1. 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
2. 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
3. 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

Overall trial start date

01/06/2014

Overall trial end date

01/10/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males and females
2. Aged 18 years old
3. Have an BMI>25

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

135

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

08/01/2015

Recruitment end date

08/01/2017

Locations

Countries of recruitment

Spain

Trial participating centre

Scientifics Aesthetics Clinics of the body
Avda. Periodista quesada Chacon numero 1
Cordoba
14071
Spain

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

University/education

Website

Funders

Funder type

University/education

Funder name

Universidad de 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 pharmacology and toxicology.

IPD sharing statement:
In order to comply with Spanish law we can not describe this information unless a writing consent from each patient has been signed.

Intention to publish date

01/04/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes