The effects of curcumin on the cardiopulmonary efficacy in subjects with central obesity: A Randomized, Double-Blind, Placebo-Controlled Trial

To determine the effects of curcumin on cardiopulmonary efficacy in subjects with central obesity

This is a triple blinded randomized controlled clinical trial phase II with a parallel group design of 50 subjects, in which a random number table was used for randomization.

Subjects include individuals with central obesity who refer to Persian cohort of the Mashhad University of Medical Sciences. All volunteers, care providers and statistician are blinded after assignment to intervention. So that, the supplements containers were coded as A and B by a non-researcher person and remained confidential until data analysis. The placebos are similar to the supplements regarding the weight and color. Subjects will be randomly assigned to one of two study groups and will receive 500 mg of curcumin or placebo over 56 days. Fasting blood samples are taken from all individuals before and after the intervention. Cardiopulmonary exercise testing (CPET) will be measured for all participants by a trained expert and physician before and after the intervention.

Inclusion criteria: Aged 18-65 years old, Subjects with central obesity based on the US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) guidelines; Exclusion criteria: History of systemic diseases, History of cardiac ischemia, Pregnancy, Breastfeeding, Hepatic failure, Hepatic failure, Biliary obstruction

The drug group (n = 25), will receive the curcumin and the control group (n = 25), will take the placebo of the same shape, weight and color with the drug at a dose of 500 mg/day over 56 days.

maximal oxygen consumption (V̇O2max)

The statistician generates a random allocation sequence using the block randomization method. So that blocks with size 4 and 2 of the combination of letters A and B (ABBA, ABAB, AABB, BAAB, BBAA, BABA), (AB and BA) are selected to the required number using a table of random numbers and individuals are assigned to groups according to the created sequence. Subjects are divided into one of two intervention/control groups using a table of random numbers, so that who enrolled the trial can select a sealed envelope with random allocation sequence to the intervention or control group. An expert outside the research team blinds the drugs. The executive team register the subjects and assign them to the intervention. All volunteers, the executive team, and the statistical analyst will be blinded by the interventions.

The random allocation sequence is made using the table of random numbers. Sequentially numbered sealed envelopes are used to implement the random allocation sequence which opened by a person not involved in the project. The participants, care providers and statistician are blinded after assignment to intervention. So that, the powders bottles are coded by a non-researcher person and remain confidential until data analysis. Moreover, In addition, placebo powder is similar to supplement powder in shape, weight and color.

Raw data will be shared upon a reasonable request from the corresponding author.

Following a reasonable request, deidentified data will be shared.

After publication of paper(s) upon a reasonable request

Study PI and executive team

For reasonable research or clinical purpose

Maryam Saberi-Karmian

Direct e-mail: saberikm@mums.ac.ir , Tel: +985138012840