Oral Curcumin Administration to Remit Metabolic Syndrome
NCT ID: NCT03795792
Last Updated: 2020-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
105 participants
INTERVENTIONAL
2018-05-06
2019-12-06
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
Study Groups
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Curcumin
Curcumin 1.2 g / black pepper 10 mg a day for 3 months, plus recommendations to decrease calories intake and do exercise.
Curcumin
Will be provided in capsules
Hydrollased collagen
Hydrolyzed collagen 1.2 g / black pepper 10 mg a day for 3 months, plus recommendations to decrease calories intake and do exercise.
Hydrolyzed collagen
Will be provided in capsules.
Interventions
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Curcumin
Will be provided in capsules
Hydrolyzed collagen
Will be provided in capsules.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 20 to 55 years old.
* Diagnosis of metabolic syndrome according to the ATP III criteria.
* Informed consent of the participant.
Exclusion Criteria
* High blood pressure o anti-hypertensive treatments.
* Hypertriglyceridemia (\>400 g/dL) or lipid lowering treatment.
* Neoplasia disease.
* Thyroid disease
* Syndrome of polycystic ovary.
* Pregnancy or lactation.
* Smoking.
* Anti-inflammatory medicines in the last two months.
* Food supplements in the last two months.
20 Years
55 Years
ALL
Yes
Sponsors
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Coordinación de Investigación en Salud, Mexico
OTHER_GOV
Responsible Party
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Fernando Guerrero Romero MD
Head of the research unit
Principal Investigators
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Fernando Guerrero, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Mexicano del Seguro Social
Luis Simental, PhD
Role: STUDY_CHAIR
Instituto Mexicano del Seguro Social
Gerardo Martínez, PhD
Role: STUDY_CHAIR
Instituto Mexicano del Seguro Social
Claudia Gamboa, PhD
Role: STUDY_CHAIR
Instituto Mexicano del Seguro Social
Locations
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Biomedical Research Unit. IMSS. Durango
Durango, Durango, Mexico
Countries
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References
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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.
Cabrera-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.
Di 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.
Jimenez-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.
Kim 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.
Metzler 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.
Mohammadi 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.
Na 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.
Na 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.
Neyrinck 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.
Rahimi 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.
Kowluru 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.
Rochlani 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.
Shao 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.
Shen 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.
Shin SK, Ha TY, McGregor RA, Choi MS. Long-term curcumin administration protects against atherosclerosis via hepatic regulation of lipoprotein cholesterol metabolism. Mol Nutr Food Res. 2011 Dec;55(12):1829-40. doi: 10.1002/mnfr.201100440. Epub 2011 Nov 7.
Yang YS, Su YF, Yang HW, Lee YH, Chou JI, Ueng KC. Lipid-lowering effects of curcumin in patients with metabolic syndrome: a randomized, double-blind, placebo-controlled trial. Phytother Res. 2014 Dec;28(12):1770-7. doi: 10.1002/ptr.5197. Epub 2014 Aug 6.
Other Identifiers
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R-2017-785-132
Identifier Type: -
Identifier Source: org_study_id
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