Assessing the effect of Functional Edible Powder Enriched with Probiotics, Curcumin, or Their Combination on Some Inflammatory Markers, Fasting Blood Glucose, and Blood Pressure in Overweight or Obese Individuals with Metabolic Syndrome: a Randomized, double-blind, controlled clinical trial

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

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.

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.

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.

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.

TNF-a; IL-6; hs-CRP

Randomization will perform using the random block method (1: 1: 1: 1 ratio) for four groups (one control and three intervention groups). In this method, blocks of four 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 four 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.

In this study, the produced edible functional powders (including 3 types of powders) and the placebo are the same in color, odor, and taste. The sachets of all four types of powder will be quite similar in appearance, color, and size. Sachets will be named A, B, C, and D. The process of filling and naming the sachets will be done by an out-of-study person. Also, study groups will be named in accordance with the letters on the sachets. Therefore, in this study, participants and the research team (Including the principal investigator, investigators, clinical caregiver, and outcome assessor) will be blinded to the type of powder consumed by each participant until the end of the data analysis process.