Metabolic SyndromeNCT03795792
Oral Curcumin Administration to Remit Metabolic Syndrome
A study testing Curcumin and Hydrolyzed collagen in people with Metabolic Syndrome, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
The metabolic syndrome consists of a set of risk factors that increases the probability to develop heart diseases and type 2 diabetes, two of the principal chronic diseases that affect Mexican population. The curcumin is a compound that is extracted from the root of a plant called Cúrcuma longa. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Curcumin and Hydrolyzed collagen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteMexico
- Study dates
- 6 May 2018to 6 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women and men.
- 20 to 55 years old.
- Diagnosis of metabolic syndrome according to the ATP III criteria.
- Informed consent of the participant.
Who cannot join
- Diabetes or hypoglycaemic therapy.
- High blood pressure o anti-hypertensive treatments.
- Hypertriglyceridemia (>400 g/dL) or lipid lowering treatment.
- Neoplasia disease.
- Thyroid disease
- Syndrome of polycystic ovary.
Show all 10Show fewer
- Pregnancy or lactation.
- Smoking.
- Anti-inflammatory medicines in the last two months.
- Food supplements in the last two months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Oral Curcumin Administration on Metabolic Syndrome Remission.
The metabolic syndrome consists of a set of risk factors that increases the probability to develop heart diseases and type 2 diabetes, two of the principal chronic diseases that affect Mexican population. The curcumin is a compound that is extracted from the root of a plant called Cúrcuma longa. There exists information that curcumin helps to diminish weight and the levels of blood glucose and blood fats. The hypothesis of this study is: that curcumin administration combined with diet and exercise remits the metabolic syndrome.
Read the detailed description
Objective: The aim of this study is to determinate the efficacy of oral administration of curcumin in the remission of metabolic syndrome.
Design: clinical trial, randomized, double blind, placebo controlled.
Study population: Men and women from 20 to 55 years old with metabolic syndrome according to the ATP III criteria, will be included.
Study groups: intervention and control group.
Sample size: It was calculated using a statistical power of 80%, an alpha value of 0.05. A 50% of the difference in the mean of remission of metabolic syndrome between control group and intervention groups was considered. The estimated sample size was 220 subjects for each group.
Process: All eligible participants according to inclusion and exclusion criteria, will be randomized to one of the study groups.
The intervention group will receive a total dose of curcumin 1.2 g / black pepper 10 mg a day; and control group will receive a total dose of hydrolyzed collagen 1.2 g / black pepper 10 mg a day; plus dietary and exercise recommendations for both groups during three months.
The blood concentrations of glucose, triglycerides, and HDL cholesterol will be measured, as well as the abdominal perimeter and blood pressure, at baseline conditions, at one month and three months after treatment.
Statistical analysis: Numerical values will be expressed as mean ± standard deviation; categorical variables will be expressed as proportions. Differences between the groups were estimated by unpaired Student t test for numerical variables (Mann-Whitney U test for skewed data) or Chi-square and Fisher´s exact test for categorical variables. Intragroup differences were estimated by paired Student t-test.
- Conditions
- Metabolic Syndrome
- Being tested
- Curcumin, Hydrolyzed collagen
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
Also called Turmeric
Will be provided in capsules
Hydrolyzed collagenDietary supplement
Will be provided in capsules.
| Study group | Role | What they receive |
|---|---|---|
| Curcumin | Experimental | Curcumin 1.2 g / black pepper 10 mg a day for 3 months, plus recommendations to decrease calories intake and do exercise. Receives: Dietary Supplement: Curcumin |
| Hydrollased collagen | Placebo comparator | Hydrolyzed collagen 1.2 g / black pepper 10 mg a day for 3 months, plus recommendations to decrease calories intake and do exercise. Receives: Dietary Supplement: Hydrolyzed collagen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of metabolic syndrome.
Presence of two or less metabolic syndrome criteria, according to the ATP III criteria.
Measured: Three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start6 May 2018
- Primary completion6 Aug 2019
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study groups: Intervention group: curcumin 1.2 g / black pepper 10 mg a day for 3 months, plus recommendations to decrease calories intake and do exercise. Control group: hydrolyzed collagen 1.2 g / black pepper 10 mg a day for 3 months, plus recommendations to decrease calories intake and do exercise.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fernando Guerrero Romero MD, Coordinación de Investigación en Salud, Mexico
- Investigators
- Fernando Guerrero, PhD, Principal investigator, Instituto Mexicano del Seguro SocialLuis Simental, PhD, Study chair, Instituto Mexicano del Seguro SocialGerardo Martínez, PhD, Study chair, Instituto Mexicano del Seguro SocialClaudia Gamboa, PhD, Study chair, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795792
- Sponsor's protocol ID
- R-2017-785-132
- Status last verified
- Apr 2020
- First submitted
- 4 Jan 2019
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Azhar Y, Parmar A, Miller CN, Samuels JS, Rayalam S. Phytochemicals as novel agents for the induction of browning in white adipose tissue. Nutr Metab (Lond). 2016 Dec 3;13:89. doi: 10.1186/s12986-016-0150-6. eCollection 2016.
PubMed 27980598Cabrera-Rode E, Stusser B, Calix W, Orlandi N, Rodriguez J, Cubas-Duenas I, Echevarria R, Alvarez A. [Diagnostic concordance between seven definitions of metabolic syndrome in overweight and obese adults]. Rev Peru Med Exp Salud Publica. 2017 Jan-Mar;34(1):19-27. doi: 10.17843/rpmesp.2017.341.2763. Spanish.
PubMed 28538842Di Pierro F, Bressan A, Ranaldi D, Rapacioli G, Giacomelli L, Bertuccioli A. Potential role of bioavailable curcumin in weight loss and omental adipose tissue decrease: preliminary data of a randomized, controlled trial in overweight people with metabolic syndrome. Preliminary study. Eur Rev Med Pharmacol Sci. 2015 Nov;19(21):4195-202.
PubMed 26592847Jimenez-Osorio AS, Monroy A, Alavez S. Curcumin and insulin resistance-Molecular targets and clinical evidences. Biofactors. 2016 Nov 12;42(6):561-580. doi: 10.1002/biof.1302. Epub 2016 Jun 21.
PubMed 27325504Kim M, Kim Y. Hypocholesterolemic effects of curcumin via up-regulation of cholesterol 7a-hydroxylase in rats fed a high fat diet. Nutr Res Pract. 2010 Jun;4(3):191-5. doi: 10.4162/nrp.2010.4.3.191. Epub 2010 Jun 28.
PubMed 20607063Metzler M, Pfeiffer E, Schulz SI, Dempe JS. Curcumin uptake and metabolism. Biofactors. 2013 Jan-Feb;39(1):14-20. doi: 10.1002/biof.1042. Epub 2012 Sep 20.
PubMed 22996406Mohammadi A, Sahebkar A, Iranshahi M, Amini M, Khojasteh R, Ghayour-Mobarhan M, Ferns GA. Effects of supplementation with curcuminoids on dyslipidemia in obese patients: a randomized crossover trial. Phytother Res. 2013 Mar;27(3):374-9. doi: 10.1002/ptr.4715. Epub 2012 May 21.
PubMed 22610853Na LX, Yan BL, Jiang S, Cui HL, Li Y, Sun CH. Curcuminoids Target Decreasing Serum Adipocyte-fatty Acid Binding Protein Levels in Their Glucose-lowering Effect in Patients with Type 2 Diabetes. Biomed Environ Sci. 2014 Nov;27(11):902-6. doi: 10.3967/bes2014.127.
PubMed 25374024Na LX, Li Y, Pan HZ, Zhou XL, Sun DJ, Meng M, Li XX, Sun CH. Curcuminoids exert glucose-lowering effect in type 2 diabetes by decreasing serum free fatty acids: a double-blind, placebo-controlled trial. Mol Nutr Food Res. 2013 Sep;57(9):1569-77. doi: 10.1002/mnfr.201200131. Epub 2012 Aug 29.
PubMed 22930403Neyrinck AM, Alligier M, Memvanga PB, Nevraumont E, Larondelle Y, Preat V, Cani PD, Delzenne NM. Curcuma longa extract associated with white pepper lessens high fat diet-induced inflammation in subcutaneous adipose tissue. PLoS One. 2013 Nov 19;8(11):e81252. doi: 10.1371/journal.pone.0081252. eCollection 2013.
PubMed 24260564Rahimi HR, Mohammadpour AH, Dastani M, Jaafari MR, Abnous K, Ghayour Mobarhan M, Kazemi Oskuee R. The effect of nano-curcumin on HbA1c, fasting blood glucose, and lipid profile in diabetic subjects: a randomized clinical trial. Avicenna J Phytomed. 2016 Sep-Oct;6(5):567-577.
PubMed 27761427Kowluru RA, Kanwar M. Effects of curcumin on retinal oxidative stress and inflammation in diabetes. Nutr Metab (Lond). 2007 Apr 16;4:8. doi: 10.1186/1743-7075-4-8.
PubMed 17437639Rochlani Y, Pothineni NV, Kovelamudi S, Mehta JL. Metabolic syndrome: pathophysiology, management, and modulation by natural compounds. Ther Adv Cardiovasc Dis. 2017 Aug;11(8):215-225. doi: 10.1177/1753944717711379. Epub 2017 Jun 22.
PubMed 28639538Shao W, Yu Z, Chiang Y, Yang Y, Chai T, Foltz W, Lu H, Fantus IG, Jin T. Curcumin prevents high fat diet induced insulin resistance and obesity via attenuating lipogenesis in liver and inflammatory pathway in adipocytes. PLoS One. 2012;7(1):e28784. doi: 10.1371/journal.pone.0028784. Epub 2012 Jan 9.
PubMed 22253696Shen L, Ji HF. The pharmacology of curcumin: is it the degradation products? Trends Mol Med. 2012 Mar;18(3):138-44. doi: 10.1016/j.molmed.2012.01.004. Epub 2012 Mar 1.
PubMed 22386732
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Curcumin Administration on Metabolic Syndrome Remission.
- ClinicalTrials.gov ID
- NCT03795792
- Acronym / sponsor ID
- R-2017-785-132
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 6 May 2018 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The metabolic syndrome consists of a set of risk factors that increases the probability to develop heart diseases and type 2 diabetes, two of the principal chronic diseases that affect Mexican population. The curcumin is a compound that is extracted from the root of a plant called Cúrcuma longa. There exists information that curcumin helps to diminish weight and the levels of blood glucose and blood fats. The hypothesis of this study is: that curcumin administration combined with diet and exercise remits the metabolic syndrome.
Detailed description
Objective: The aim of this study is to determinate the efficacy of oral administration of curcumin in the remission of metabolic syndrome.
Design: clinical trial, randomized, double blind, placebo controlled.
Study population: Men and women from 20 to 55 years old with metabolic syndrome according to the ATP III criteria, will be included.
Study groups: intervention and control group.
Sample size: It was calculated using a statistical power of 80%, an alpha value of 0.05. A 50% of the difference in the mean of remission of metabolic syndrome between control group and intervention groups was considered. The estimated sample size was 220 subjects for each group.
Process: All eligible participants according to inclusion and exclusion criteria, will be randomized to one of the study groups.
The intervention group will receive a total dose of curcumin 1.2 g / black pepper 10 mg a day; and control group will receive a total dose of hydrolyzed collagen 1.2 g / black pepper 10 mg a day; plus dietary and exercise recommendations for both groups during three months.
The blood concentrations of glucose, triglycerides, and HDL cholesterol will be measured, as well as the abdominal perimeter and blood pressure, at baseline conditions, at one month and three months after treatment.
Statistical analysis: Numerical values will be expressed as mean ± standard deviation; categorical variables will be expressed as proportions. Differences between the groups were estimated by unpaired Student t test for numerical variables (Mann-Whitney U test for skewed data) or Chi-square and Fisher´s exact test for categorical variables. Intragroup differences were estimated by paired Student t-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Study groups: Intervention group: curcumin 1.2 g / black pepper 10 mg a day for 3 months, plus recommendations to decrease calories intake and do exercise. Control group: hydrolyzed collagen 1.2 g / black pepper 10 mg a day for 3 months, plus recommendations to decrease calories intake and do exercise.
| Arm | Type | Receives |
|---|---|---|
| Curcumin | Experimental | Dietary Supplement: CurcuminCurcumin 1.2 g / black pepper 10 mg a day for 3 months, plus recommendations to decrease calories intake and do exercise. |
| Hydrollased collagen | Placebo comparator | Dietary Supplement: Hydrolyzed collagenHydrolyzed collagen 1.2 g / black pepper 10 mg a day for 3 months, plus recommendations to decrease calories intake and do exercise. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women and men.
- 20 to 55 years old.
- Diagnosis of metabolic syndrome according to the ATP III criteria.
- Informed consent of the participant.
Key exclusion criteria (10 listed)
- Diabetes or hypoglycaemic therapy.
- High blood pressure o anti-hypertensive treatments.
- Hypertriglyceridemia (>400 g/dL) or lipid lowering treatment.
- Neoplasia disease.
- Thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminAlso: TurmericWill be provided in capsules | Dietary supplement | Curcumin |
| Hydrolyzed collagenWill be provided in capsules. | Dietary supplement | Hydrollased collagen |
Primary outcome
Remission of metabolic syndrome.
Time frame: Three months.
Presence of two or less metabolic syndrome criteria, according to the ATP III criteria.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Background: PubMed 27980598Azhar Y, Parmar A, Miller CN, Samuels JS, Rayalam S. Phytochemicals as novel agents for the induction of browning in white adipose tissue. Nutr Metab (Lond). 2016 Dec 3;13:89. doi: 10.1186/s12986-016-0150-6. eCollection 2016.
- Background: PubMed 28538842Cabrera-Rode E, Stusser B, Calix W, Orlandi N, Rodriguez J, Cubas-Duenas I, Echevarria R, Alvarez A. [Diagnostic concordance between seven definitions of metabolic syndrome in overweight and obese adults]. Rev Peru Med Exp Salud Publica. 2017 Jan-Mar;34(1):19-27. doi: 10.17843/rpmesp.2017.341.2763. Spanish.
- Background: PubMed 26592847Di Pierro F, Bressan A, Ranaldi D, Rapacioli G, Giacomelli L, Bertuccioli A. Potential role of bioavailable curcumin in weight loss and omental adipose tissue decrease: preliminary data of a randomized, controlled trial in overweight people with metabolic syndrome. Preliminary study. Eur Rev Med Pharmacol Sci. 2015 Nov;19(21):4195-202.
- Background: PubMed 27325504Jimenez-Osorio AS, Monroy A, Alavez S. Curcumin and insulin resistance-Molecular targets and clinical evidences. Biofactors. 2016 Nov 12;42(6):561-580. doi: 10.1002/biof.1302. Epub 2016 Jun 21.
- Background: PubMed 20607063Kim M, Kim Y. Hypocholesterolemic effects of curcumin via up-regulation of cholesterol 7a-hydroxylase in rats fed a high fat diet. Nutr Res Pract. 2010 Jun;4(3):191-5. doi: 10.4162/nrp.2010.4.3.191. Epub 2010 Jun 28.
- Background: PubMed 22996406Metzler M, Pfeiffer E, Schulz SI, Dempe JS. Curcumin uptake and metabolism. Biofactors. 2013 Jan-Feb;39(1):14-20. doi: 10.1002/biof.1042. Epub 2012 Sep 20.
- Background: PubMed 22610853Mohammadi A, Sahebkar A, Iranshahi M, Amini M, Khojasteh R, Ghayour-Mobarhan M, Ferns GA. Effects of supplementation with curcuminoids on dyslipidemia in obese patients: a randomized crossover trial. Phytother Res. 2013 Mar;27(3):374-9. doi: 10.1002/ptr.4715. Epub 2012 May 21.
- Background: PubMed 25374024Na LX, Yan BL, Jiang S, Cui HL, Li Y, Sun CH. Curcuminoids Target Decreasing Serum Adipocyte-fatty Acid Binding Protein Levels in Their Glucose-lowering Effect in Patients with Type 2 Diabetes. Biomed Environ Sci. 2014 Nov;27(11):902-6. doi: 10.3967/bes2014.127.
- Background: PubMed 22930403Na LX, Li Y, Pan HZ, Zhou XL, Sun DJ, Meng M, Li XX, Sun CH. Curcuminoids exert glucose-lowering effect in type 2 diabetes by decreasing serum free fatty acids: a double-blind, placebo-controlled trial. Mol Nutr Food Res. 2013 Sep;57(9):1569-77. doi: 10.1002/mnfr.201200131. Epub 2012 Aug 29.
- Background: PubMed 24260564Neyrinck AM, Alligier M, Memvanga PB, Nevraumont E, Larondelle Y, Preat V, Cani PD, Delzenne NM. Curcuma longa extract associated with white pepper lessens high fat diet-induced inflammation in subcutaneous adipose tissue. PLoS One. 2013 Nov 19;8(11):e81252. doi: 10.1371/journal.pone.0081252. eCollection 2013.
- Background: PubMed 27761427Rahimi HR, Mohammadpour AH, Dastani M, Jaafari MR, Abnous K, Ghayour Mobarhan M, Kazemi Oskuee R. The effect of nano-curcumin on HbA1c, fasting blood glucose, and lipid profile in diabetic subjects: a randomized clinical trial. Avicenna J Phytomed. 2016 Sep-Oct;6(5):567-577.
- Background: PubMed 17437639Kowluru RA, Kanwar M. Effects of curcumin on retinal oxidative stress and inflammation in diabetes. Nutr Metab (Lond). 2007 Apr 16;4:8. doi: 10.1186/1743-7075-4-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Guerrero, PhD principal investigator
Instituto Mexicano del Seguro Social
Luis Simental, PhD study chair
Instituto Mexicano del Seguro Social
Gerardo Martínez, PhD study chair
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin and Hydrolyzed collagen in people with Metabolic Syndrome, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission of metabolic syndrome. (time frame: Three months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03795792, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.