]>
IRCT20220315054289N1 IRCT 2022-04-01 Shiraz University of Medical Sciences Investigating the effect 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 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 2022-06-22 anticipated 128 Complete https://irct.ir/trial/62635 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Metabolic syndrome. Intervention 1: Intervention group 1: Dissolve and receive curcumin-enriched edible functional powder containing 1000 mg of curcumin (Karen Pharma and Food Supplement Co.) in water daily for 8 weeks. They also follow a low-calorie diet with a reduction of 500 kcal during the study. Intervention 2: Intervention group 2: Dissolve and receive probiotic-enriched edible functional powder containing 10^9 CFU of Lactobacillus rhamnosus and Lactobacillus acidophilus (Parsilact Co.) in water daily for 8 weeks. They also follow a low-calorie diet with a reduction of 500 kcal during the study. Intervention 3: Intervention group 3: Dissolve and receive curcumin-probiotic-enriched edible functional powder containing 1000 mg of curcumin (Karen Pharma and Food Supplement Co.) and 10^9 CFU of Lactobacillus rhamnosus and Lactobacillus acidophilus (Parsilact Co.) in water daily for 8 weeks. They also follow a low-calorie diet with a reduction of 500 kcal during the study. Intervention 4: Control group: Dissolve and receive placebo powder in water daily for 8 weeks. They also follow a low-calorie diet with a reduction of 500 kcal during the study. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Mohammad Ali Mohsenpour
School of Nutrition and Food Sciences, Razi Blvd., Shiraz
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3725 8099 mohammadali.mohsenpour@gmail.com Shiraz University of Medical Sciences scientific Mohammad Hassan Eftekhari
School of Nutrition and Food Sciences, Razi Blvd., Shiraz
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3725 8099 h_eftekhari@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Aged 30 - 65 years Overweight (BMI between 25 to 29.9) or obese (BMI over 30) individuals with metabolic syndrome based on ATP III criteria Not suffering from metabolic, endocrine, or cardiovascular disease (except diabetes, dyslipidemia, and hypertension) at baseline Not suffering from kidney, liver, or systemic diseases at the beginning of the study Not infected with Covid-19 or any other infections for 3 months before the study No history of hospitalization for 3 months prior to the study Has not used antibiotics for 3 months before beginning the study Has not taken curcumin and probiotic supplements, any drugs or supplements for 3 months before the study 30 years 65 years Both Pregnancy Lactating Suffering from components of the metabolic syndrome (diabetes, hypertension, or dyslipidemia) that require drug treatment E88.81 Metabolic syndrome Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group 1: Dissolve and receive curcumin-enriched edible functional powder containing 1000 mg of curcumin (Karen Pharma and Food Supplement Co.) in water daily for 8 weeks. They also follow a low-calorie diet with a reduction of 500 kcal during the study. Intervention group 2: Dissolve and receive probiotic-enriched edible functional powder containing 10^9 CFU of Lactobacillus rhamnosus and Lactobacillus acidophilus (Parsilact Co.) in water daily for 8 weeks. They also follow a low-calorie diet with a reduction of 500 kcal during the study. Intervention group 3: Dissolve and receive curcumin-probiotic-enriched edible functional powder containing 1000 mg of curcumin (Karen Pharma and Food Supplement Co.) and 10^9 CFU of Lactobacillus rhamnosus and Lactobacillus acidophilus (Parsilact Co.) in water daily for 8 weeks. They also follow a low-calorie diet with a reduction of 500 kcal during the study. Control group: Dissolve and receive placebo powder in water daily for 8 weeks. They also follow a low-calorie diet with a reduction of 500 kcal during the study. Tumor necrosis factor alpha (TNF-a) blood level. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA). Interleukin 6 (IL-6) blood level. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA). High-sensitivity C-reactive Protein (hs-CRP) blood level. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA). Fasting blood glucose. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Standard enzymatic method. Systolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Sphygmomanometer. Diastolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Sphygmomanometer. Shiraz University of Medical Sciences Approved 2022-01-16 Research Ethics Committees of Schools of Health and Nutrition-Shiraz University of Medical Sciences School of Health and Nutrition, Razi Blvd., Shiraz Shiraz Fars Iran (Islamic Republic of)