Clinical trial NCT03795792: Oral Curcumin Administration to Remit Metabolic Syndrome
Official title: Efficacy of Oral Curcumin Administration on Metabolic Syndrome Remission.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2019-01-08
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Remission of metabolic syndrome.
timeFrame: Three months.
Secondary outcomes:
Other outcomes:
Locations:
city: Durango
country: Mexico
facility: Biomedical Research Unit. IMSS. Durango
state: Dgo
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Fernando Guerrero, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Mexicano del Seguro Social
name: Luis Simental, PhD
role: STUDY_CHAIR
affiliation: Instituto Mexicano del Seguro Social
name: Gerardo Martínez, PhD
role: STUDY_CHAIR
affiliation: Instituto Mexicano del Seguro Social
name: Claudia Gamboa, PhD
role: STUDY_CHAIR
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