Effects of a combined treatment with Glucomannan and Garcinia cambogia on patients with obesity
| ISRCTN | ISRCTN48289853 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48289853 |
| Protocol serial number | GC/GNN-2 |
| Sponsor | University of Córdoba |
| Funder | Universidad de Córdoba |
- 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
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
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
| Primary study design | Interventional |
|---|---|
| Study design | Non randomized prospective trial evaluating differences between two dependent means (matches pairs design) |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| 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(s) |
1. Weight is measured using digital balance (HD-305 TanitaTM) to the nearest 0.1 kg at baseline, three and six months of treatment |
| Key secondary outcome measure(s) |
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 |
| Completion date | 01/10/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
Cordoba
14071
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
