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Study aim:
Determination of the effect of functional edible powder enriched with curcumin, probiotics, and their combination on TNF-a, IL-6, hs-CRP, fasting blood sugar, and blood pressure in overweight or obese individuals with metabolic syndrome
Design:
A randomized, double-blinded, phase 3 controlled clinical trial with four parallel groups. 32 individuals (a total of 128) randomly enter the groups using random blocks.
Settings and conduct:
128 eligible individuals referred to Imam Reza clinic in Shiraz, after informing and obtaining informed consent, are randomly assigned to 4 study groups. Participants along with a low-calorie diet, receive their group powders, which are named the same as the groups with the letters A, B, C, and D to blind the participant and the researcher, in water for 8 weeks daily. Inflammatory markers, fasting blood glucose, and blood pressure will be assessed before and after the study.
Participants/Inclusion and exclusion criteria:
Inclusion criteria: overweight or obese individuals aged 30 to 65 with metabolic syndrome based on ATP III criteria; not suffering from metabolic, endocrine, or chronic diseases, covid-19, or any kind of infection; Not hospitalized, has not used antibiotics, curcumin, and probiotic supplements or any medications and supplements for 3 months before the study. Non-inclusion criteria: pregnancy; lactation; having components of the metabolic syndrome that require drug treatment.
Intervention groups:
Participants dissolve and consume powders in water daily for 8 weeks powders which include edible functional powders enriched with 1000 mg curcumin (Group I), 10^9 CFU probiotics (Group II), and 1000 mg curcumin with 10^9 CFU Probiotics (Group III), and placebo powder (Group IV). Also, all participants will receive a low-calorie diet with a reduction of 500 kcal according to their weight.
Main outcome variables:
TNF-a; IL-6; hs-CRP