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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 : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Fernando Guerrero Romero MD, Coordinación de Investigación en Salud, Mexico

Tracking Information
First Submitted Date  ICMJE January 4, 2019
First Posted Date  ICMJE January 8, 2019
Last Update Posted Date January 16, 2019
Actual Study Start Date  ICMJE May 6, 2018
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2019)
Remission of metabolic syndrome. [ Time Frame: Three months. ]
Presence of two or less metabolic syndrome criteria, according to the ATP III criteria.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03795792 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Curcumin Administration to Remit Metabolic Syndrome
Official Title  ICMJE Efficacy of Oral Curcumin Administration on Metabolic Syndrome Remission.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Dietary Supplement: Curcumin
    Will be provided in capsules
    Other Name: Turmeric
  • Dietary Supplement: Hydrolyzed collagen
    Will be provided in capsules.
Study Arms  ICMJE
  • Experimental: Curcumin
    Curcumin 1.2 g / black pepper 10 mg a day for 3 months, plus recommendations to decrease calories intake and do exercise.
    Intervention: Dietary Supplement: Curcumin
  • 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.
    Intervention: Dietary Supplement: Hydrolyzed collagen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 7, 2019)
440
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Fernando Guerrero, PhD 526188120997 guerrero.romero@gmail.com
Contact: Lucia Preza 526181891133 preza8289@gmail.com
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03795792
Other Study ID Numbers  ICMJE R-2017-785-132
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fernando Guerrero Romero MD, Coordinación de Investigación en Salud, Mexico
Study Sponsor  ICMJE Coordinación de Investigación en Salud, Mexico
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Coordinación de Investigación en Salud, Mexico
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP