Determination of the Effect of Functional Oral Powder Enriched with Curcumin, Probiotics, and their Combination on Cardiometabolic Indices in Patients with Metabolic Syndrome with Overweight or Obesity: a Randomized, Double-blinded, Controlled Clinical Trial

The aim of this study is to evaluate the effect of oral powder enriched with curcumin and probiotics on cardiometabolic indices of patients with metabolic syndrome

A parallel randomized double-blind controlled clinical trial of 124 patients. Block randomization with a fixed block size of 4 will be done

Patients with metabolic syndrome are referred to the Nutrition Clinic of Imam Reza Clinic, Shiraz, and are randomly divided into 4 study groups. The informed consent form, demographic information, international physical activity questionnaire (IPAQ), and 3-day food record are completed for all individuals before and after the study. Anthropometric measurements and measurements of the lipid profile are performed before and after the study. The appearance of the intervention powders is quite similar. The researcher and all participants will be blinded to the intervention and random allocation. Laboratory evaluations will be done in the nutrition laboratory of the Faculty of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.

Inclusion criteria: people 30 to 65 years old with metabolic syndrome. Exclusion criteria: pregnant and lactating people and people with kidney, liver, systemic, metabolic, endocrine, and cardiovascular diseases except diabetes, dyslipidemia, and blood pressure.

Group 1 receives functional curcumin-enriched oral powder. Group 2 receives the functional probiotics-enriched oral powder. Group 3 receives the functional oral powder enriched with curcumin and probiotics. Group 4 receives the placebo oral powder.

Cardiometabolic indices:Atherogenic Index of Plasma = AIP Atherogenic Coefficient = AC Castelli Risk Index I Castelli Risk Index II

Before beginning the study, an outsider who is familiar with the randomization method prepares 4 blocks of random blocks, then randomly identifies the sequences and groups them in a closed envelope, named A, B, C, and D. After the individuals enter the study, the sealed envelopes containing the assigned group of participants will be opened for each participant based on the sequence determined by the person outside the study. Block randomization works by randomizing participants within blocks such that an equal number is assigned to each treatment. Allocation proceeds by randomly selecting one of the orderings and assigning the next block of participants to study groups according to the specified sequence. Furthermore, the block size must be divisible by the number of study groups.

The appearance of the beverage powders and sachets in which they are packaged are quite similar. The sachets will be named with the Latin letters A, B, C, and D. In the clinical phase of the study, the random allocation sequence is done with the same letters. Therefore, the researcher and all participants will be blinded to the intervention.