Production of Functional Oral Powder Enriched with Curcumin, Probiotics, and their Combination and Determination of their Effect on Appetite, Leptin, and Ghrelin Hormones and Some Anthropometric Indices in Patients with Metabolic Syndrome with Overweight or Obesity: a Randomized Double-Blind Controlled Clinical Trial

The aim of this study is to evaluate the effect of oral powder enriched with curcumin and probiotics on appetite, leptin and ghrelin hormones, and some anthropometric 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 Imam Reza Clinic and are randomly divided into 4 study groups. The informed consent form, demographic information, physical activity (IPAQ), 3-day food record, and visual appetite scale (VAS) questionnaires are completed for all individuals before and after the study. Anthropometric measurements and evaluation of leptin and ghrelin hormones 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.

Inclusion criteria: people 30 to 65 years old with metabolic syndrome (MS) Non-inclusion criteria: pregnancy; lactation; Kidney, liver, systemic, metabolic, endocrine, and cardiovascular diseases except diabetes, dyslipidemia, and hypertension; take any supplements or antibiotics during 3 previous months.

Group 1 receives the 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.

Primary outcomes: leptin hormone, ghrelin hormone, and appetite status Secondary outcomes: anthropometric factors

Due to the lack of sufficient budgets, it was not possible to measure blood lipid indices after the study, and these indices were removed from the title. Also, due to the fact that most patients with metabolic syndrome were taking medication, we had difficulty finding patients and had to change the inclusion criteria. Finally, we included the patients who were receiving medicine in the study.

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.

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.