Oral Curcumin Administration to Remit Metabolic Syndrome

NCT03795792 | Completed

• 1 other identifier: R-2017-785-132
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Remission of metabolic syndrome.

  Presence of two or less metabolic syndrome criteria, according to the ATP III criteria.

  Three months.

Study Arms (2)

Curcumin

EXPERIMENTAL

Curcumin 1.2 g / black pepper 10 mg a day for 3 months, plus recommendations to decrease calories intake and do exercise.

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.

Dietary Supplement: Hydrolyzed collagen

Interventions

Curcumin DIETARY_SUPPLEMENT

Will be provided in capsules

Also known as: Turmeric

Curcumin

Hydrolyzed collagen DIETARY_SUPPLEMENT

Will be provided in capsules.

Hydrollased collagen

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women and men.
• to 55 years old.
• Diagnosis of metabolic syndrome according to the ATP III criteria.
• Informed consent of the participant.

You may not qualify if:

• 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.
• Pregnancy or lactation.
• Smoking.
• Anti-inflammatory medicines in the last two months.
• Food supplements in the last two months.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Biomedical Research Unit. IMSS. Durango

Durango, Durango, 34067, Mexico

Location

Related Publications (17)

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  PMID: 27980598 BACKGROUND

• 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.

  PMID: 28538842 BACKGROUND

• 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.

  PMID: 26592847 BACKGROUND

• 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.

  PMID: 27325504 BACKGROUND

• 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.

  PMID: 20607063 BACKGROUND

• 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.

  PMID: 22996406 BACKGROUND

• 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.

  PMID: 22610853 BACKGROUND

• 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.

  PMID: 25374024 BACKGROUND

• 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.

  PMID: 22930403 BACKGROUND

• 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.

  PMID: 24260564 BACKGROUND

• 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.

  PMID: 27761427 BACKGROUND

• 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.

  PMID: 17437639 BACKGROUND

• 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.

  PMID: 28639538 BACKGROUND

• 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.

  PMID: 22253696 BACKGROUND

• 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.

  PMID: 22386732 BACKGROUND

• 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.

  PMID: 22058071 BACKGROUND

• 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.

  PMID: 25131839 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Fernando Guerrero, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

• Luis Simental, PhD

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

• Gerardo Martínez, PhD

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

• Claudia Gamboa, PhD

  Instituto Mexicano del Seguro Social

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Neither the patient nor the treating doctor will know the study group the participant was randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the research unit

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 8, 2019
• Study Start: May 6, 2018
• Primary Completion: August 6, 2019
• Study Completion: December 6, 2019
• Last Updated: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)