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
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