Effects of Garcinia cambogia/Glucomannan on weight loss
| ISRCTN | ISRCTN78807585 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78807585 |
| Secondary identifying numbers | GC/GNN1 |
- Submission date
- 08/09/2017
- Registration date
- 19/09/2017
- Last edited
- 25/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Overweight and obesity are considered major health problems that contribute to increase mortality (death) and quality of life. Both conditions have a high prevalence across the world reaching epidemic (widespread) numbers. Weight loss supplements are becoming popular as a weight to lose fat. Garcinia cambogia (GC) is a fruit that has an ingredient that is rumored to help with weight loss. Glucomannan (GNN) is an ingredient derived from a plant that is 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 are overweight.
What does the study involve?
Participants are told to keep a balanced diet, eat regular meals and drink plenty of water. Participants are told to ingest capsules of GC and capsules of GNN twice a day, half an hour before lunch and dinner for six months. Participants are told to exercise, avoid smoking and control their alcohol intake.
What are the possible benefits and risks of participating?
Participants may benefit from weight loss. There are no risks with participating.
Where is the study run from?
1. Scientifics Aesthetics Clinics of the body Córdoba (Spain)
2. Hospital e Maternidade São Francisco de Assis (Brazil)
When is the study starting and how long is it expected to run for?
February 2015 to March 2017
Who is funding the study?
University of Córdoba (Spain)
Who is the main contact?
Professor José Lancho
Contact information
Scientific
Department of Morphological Sciences
School of Medicine
University of Córdoba
Avenida de Menéndez Pidal s/n
Córdoba
14071
Spain
 ORCID ID |
0000-0002-2163-3304 |
|---|
Study information
| Study design | Multicentric, 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 | Long-term effects of Garcinia cambogia/Glucomannan on weight loss in people with obesity, PLIN4, FTO and Trp64Arg polymorphisms |
| Study hypothesis | The aim of this study is to assess whether a controlled diet supplemented with GC and GNN was able to reduce weight after 3 and 6 moths in people with overweight or obesity. Another aim of this study is to evaluate if this reduction was modified by the presence in the patients of different genetic polymorphism related to FTO (rs9939609 A/T), PLIN4 (11482G>A) and ADRB3Trp64Arg. |
| Ethics approval(s) | 1. Ethical Boards of Hospital Universitario Reina Sofia de Córdoba (Spain), 14/09/2014 2. Hospital e Maternidade São Francisco de Assis, Crato (Brasil), 21/01/2015 |
| Condition | Obesity/overweight |
| Intervention | Participants are advised to 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 6 months. It was recommended to patients to practice physical exercise, avoid smoking, and control alcohol intake. |
| 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 4. 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 5. 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 6. 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 |
| Secondary outcome measures | Interaction of different polymorphism with primary outcome measures is measured using analysis of covariance or correlation through Pearson correlation test (for continuous variable such as age) at baseline, three and six months of treatment. |
| Overall study start date | 08/02/2015 |
| Overall study end date | 08/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 214 |
| Total final enrolment | 214 |
| Participant inclusion criteria | 1. Males and females 2. Aged 18 years old 3. Have an BMC>25 and could be suffering dyslipidemias, hypertension, DM2 or their combinations |
| 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 | 12/02/2015 |
| Recruitment end date | 08/03/2015 |
Locations
Countries of recruitment
- Brazil
- Spain
Study participating centres
14071
Spain
63105
Brazil
Sponsor information
Hospital/treatment centre
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
No information available
Results and Publications
| Intention to publish date | 13/09/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned submission to peer review evaluation to BMC alternative and complementary medicine. |
| IPD sharing plan | Data related to this study are stored in Department of Morphological Sciences, School of Medicine, University of Córdoba, Spain. Mailing address: Avenida de Menéndez Pidal s/n 14071 Córdoba, Spain. Phone: +34 957218256. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. Prof, José L. Lancho at Department of Morphological Sciences, School of Medicine, University of Córdoba, Spain. Mailing address: Avenida de Menéndez Pidal s/n 14071 Córdoba, Spain. Phone: +34 957218256 All patients were informed and signed the proper informed consent. This work was in accordance with Helsinki declaration. Participant information was encrypted assigning different numbers to each participant. Participant personal information is protected by spanish law (Ley Orgánica 15/1999, de 13 de diciembre, de Protección de Datos de Carácter Personal) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 24/01/2018 | 25/11/2020 | Yes | No |
Editorial Notes
25/11/2020: Publication reference and total final enrolment number added.
