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Oral Curcumin Administration to Remit Metabolic Syndrome

Sponsor
Coordinación de Investigación en Salud, Mexico (Other)
Overall Status
Completed
CT.gov ID
NCT03795792
Collaborator
(none)
105
Enrollment
1
Location
2
Arms
19
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Dietary Supplement: Curcumin
  • Dietary Supplement: Hydrolyzed collagen
 N/A

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

Study Type:
Interventional
Actual Enrollment :
105 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.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
Actual Primary Completion Date :
Aug 6, 2019
Actual Study Completion Date :
Dec 6, 2019

Arms and Interventions

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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Remission of metabolic syndrome. [Three months.]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Biomedical Research Unit. IMSS. Durango Durango Dgo Mexico 34067

    Sponsors and Collaborators

    • Coordinación de Investigación en Salud, Mexico

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fernando Guerrero Romero MD, Head of the research unit, Coordinación de Investigación en Salud, Mexico
    ClinicalTrials.gov Identifier:
    NCT03795792
    Other Study ID Numbers:
    • R-2017-785-132
    First Posted:
    Jan 8, 2019
    Last Update Posted:
    Apr 17, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Metabolic Syndrome
    Syndrome
    Curcumin

    Study Results

    No Results Posted as of Apr 17, 2020