Oral Curcumin Administration to Remit Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

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.
    

Intervention name(s): Curcumin; Hydrolyzed collagen
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Will be provided in capsules; Will be provided in capsules.
Other intervention name(s): Turmeric
Intervention MeSH terms: Curcumin
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)
Primary purpose: Treatment