Determination the effect of calcium and vitamin B12 co-supplementation on some anthropometric indices, blood glucose, lipid profile and blood pressure in Individuals with metabolic syndrome: a randomized triple-blind controlled clinical trial

Determination the effect of calcium and vitamin B12 co-supplementation on some anthropometric indices, blood glucose, lipid profile and blood pressure in Individuals with metabolic syndrome

This study is a randomized, triple-blinded, phase 3 controlled clinical trial with 2 parallel groups ( intervention and control groups). 56 individuals (28 in each group) were randomized into groups with balanced-blocked randomization.

Patients will be selected from clinics and health centers in the city of Shiraz, if desired. Participants will be given educational pamphlets and dietary recommendations to standardize their eating behaviors and prevent drastic and sudden changes in their diet. After a two-week run-in period to standardize dietary behaviors, these individuals will be randomly assigned to two groups.

Inclusion criteria : Individuals with metabolic syndrome Aged 18 to 65 years according to ATPIII Not suffering from kidney, liver, chronic diseases, malignancies, and systemic diseases Not supplementation of calcium, vitamin B12, chromium, magnesium, and vitamin D for the past 3 months before the study. Exclusion criteria: Pregnancy and lactation

Intervention group: 28 participants will consume Calcium (500 mg CaCO3) and vitamin B12 (500 mic gr cyanocobalamin) daily with 2 main meals for 8 weeks Control group : 28 participants will consume Placebo(2 capsules of similar supplements)daily with 2 main meals for 8 weeks

Blood glucose, serum insulin , HOMA-IR index

Randomization will perform using the random block method (1: 1 ratio) for 2 groups ( intervention and control groups). In this method, blocks of two with rotation will be created by an out-of-study person. Then, a block will be randomly selected to determine the groups assigned to the first two participants. The random-blocks selection process will be repeated to determine the random allocation for the entire sample size. For allocation concealment, after determining the random sequence, these sequences will be placed in numbered sealed opaqued envelopes for each participant. An out-of-study person familiar with randomization will perform this process. During the study, by entering any participant in the study, based on the sequence, an envelope will be opened and the allocated group will be revealed.

After determining the random allocation sequence, groups are named A and B based on the assigned names A and B in order and according to the sequence specified in the packets by the person outside the study. Then, based on the assigned blocks, supplements are provided to the participants. Participants are unaware of their assignment to the supplement or placebo group. After collecting the data, the results of the outcomes are analyzed based on groups A and B.