Oral Curcumin Administration to Remit Metabolic Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03795792|
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : July 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Dietary Supplement: Curcumin Dietary Supplement: Hydrolyzed collagen||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||440 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
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.|
|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|
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.
- Remission of metabolic syndrome. [ Time Frame: Three months. ]Presence of two or less metabolic syndrome criteria, according to the ATP III criteria.
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
|Contact: Fernando Guerrero, PhDfirstname.lastname@example.org|
|Contact: Lucia Prezaemail@example.com|
|Biomedical Research Unit. IMSS. Durango||Recruiting|
|Durango, Dgo, Mexico, 34067|
|Contact: Fernando Guerrero, PhD +526188120997 firstname.lastname@example.org|
|Contact: Gerardo Martinez, PhD +526188120997 email@example.com|
|Sub-Investigator: Luis Simental, PhD|
|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|