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Oral Curcumin Administration to Remit Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT03795792
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Fernando Guerrero Romero MD, Coordinación de Investigación en Salud, Mexico

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Curcumin Dietary Supplement: Hydrolyzed collagen Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider)
Masking Description: Neither the patient nor the treating doctor will know the study group the participant was randomized.
Primary Purpose: Treatment
Official Title: Efficacy of Oral Curcumin Administration on Metabolic Syndrome Remission.
Actual Study Start Date : May 6, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Curcumin
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
Will be provided in capsules
Other Name: Turmeric

Placebo Comparator: 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.
Dietary Supplement: Hydrolyzed collagen
Will be provided in capsules.




Primary Outcome Measures :
  1. Remission of metabolic syndrome. [ Time Frame: Three months. ]
    Presence of two or less metabolic syndrome criteria, according to the ATP III criteria.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795792


Contacts
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Contact: Fernando Guerrero, PhD 526188120997 guerrero.romero@gmail.com
Contact: Lucia Preza 526181891133 preza8289@gmail.com

Locations
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Mexico
Biomedical Research Unit. IMSS. Durango Recruiting
Durango, Dgo, Mexico, 34067
Contact: Fernando Guerrero, PhD    +526188120997    guerrero.romero@gmail.com   
Contact: Gerardo Martinez, PhD    +526188120997    uimec@yahoo.es   
Sub-Investigator: Luis Simental, PhD         
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
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Principal Investigator: Fernando Guerrero, PhD Instituto Mexicano del Seguro Social
Study Chair: 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

Publications:

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Responsible Party: Fernando Guerrero Romero MD, Head of the research unit, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT03795792     History of Changes
Other Study ID Numbers: R-2017-785-132
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Enzyme Inhibitors
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action