Effects of a combined treatment with Glucomannan and Garcinia cambogia on patients with obesity

ISRCTN	ISRCTN48289853
DOI	https://doi.org/10.1186/ISRCTN48289853
Secondary identifying numbers	GC/GNN-2

Submission date: 15/01/2018
Registration date: 17/01/2018
Last edited: 17/01/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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)

Contact information

Prof José L Lancho
Scientific

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

ORCID ID	0000-0002-2163-3304

Study information

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
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	No participant information sheet available.
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
Study objectives	Combined treatment reduces weight, changes body composition and ameliorate lipid and glucose blood profiles in overweight/obese patients.
Ethics approval(s)	Ethical Boards of Hospital Universitario Reina Sofia de Córdoba (Spain), 14/09/2014, ref: GC/GNN-2
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/06/2014
Completion date	01/10/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	135
Key inclusion criteria	1. Males and females 2. Aged 18 years old 3. Have an BMI>25
Key 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
Date of first enrolment	08/01/2015
Date of final enrolment	08/01/2017

Locations

Countries of recruitment

Spain

Study participating centre

Scientifics Aesthetics Clinics of the body

Avda. Periodista quesada Chacon numero 1
Cordoba
14071
Spain

Sponsor information

University of Córdoba
University/education

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

"ROR"	https://ror.org/05yc77b46

Funders

Funder type

University/education

Universidad de Córdoba

No information available

Results and Publications

Intention to publish date	01/04/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Planned submission to peer review evaluation to BMC pharmacology and toxicology.
IPD sharing plan	In order to comply with Spanish law we can not describe this information unless a writing consent from each patient has been signed.