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 logoORCID ID 0000-0002-2163-3304

Study information

Study designNon randomized prospective trial evaluating differences between two dependent means (matches pairs design)
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet No participant information sheet available.
Scientific titleCombined 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 objectivesCombined 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) studiedObesity/overweight
InterventionParticipants 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 typeSupplement
Primary outcome measure1. 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 measures1. 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 date01/06/2014
Completion date01/10/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants135
Key inclusion criteria1. Males and females
2. Aged 18 years old
3. Have an BMI>25
Key exclusion criteria1. 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 enrolment08/01/2015
Date of final enrolment08/01/2017

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

Funders

Funder type

University/education

Universidad de Córdoba

No information available

Results and Publications

Intention to publish date01/04/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned submission to peer review evaluation to BMC pharmacology and toxicology.
IPD sharing planIn order to comply with Spanish law we can not describe this information unless a writing consent from each patient has been signed.