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IRCT20220315054290N1 IRCT 2022-04-03 Shiraz University of Medical Sciences The Effect of Oral Powder Enriched with Curcumin and Probiotics on Patients with Metabolic Syndrome 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 2022-06-22 anticipated 124 Complete https://irct.ir/trial/62616 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Metabolic syndrome. Intervention 1: The first intervention group will receive a daily oral powder enriched with 1 gram of curcumin for 8 weeks. Curcumin powder will be supplied by Karen Company. Intervention 2: The second intervention group will receive 10 to 9 CFU-enriched oral powders (Lactobacillus rhamnosus and Lactobacillus acidophilus) daily for 8 weeks. Probiotics will be provided by Parsi Lact Company. Intervention 3: The third intervention group will receive daily oral powder enriched with 1 gram of curcumin and 10 to 9 CFU probiotics for 8 weeks. Curcumin will be supplied by Karen Company and probiotics will be supplied by Parsi Lact Company. Intervention 4: The control group will receive placebo oral powder daily for 8 weeks. Placebo powder will be supplied by Parsi Lact Company. 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 Farzaneh Mohammadi
School of Nutrition & Food Sciences, Razi Blvd
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3725 8099 mohamadyfa@sums.ac.ir Shiraz University of Medical Sciences scientific Mohammad Hassan Eftekhari
School of Nurition & Food Sciences, Razi Blvd
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3725 8099 h_eftekhari@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age: 30-60 years old Metabolic syndrome patients are diagnosed based on the Adult Treatment Panel III (ATP III) criterion Consent to participate in the study 30 years 65 years Both Pregnancy Lactation Suffering from kidney, liver, and systemic diseases at the beginning of the study Metabolic, endocrine, and cardiovascular diseases except diabetes, dyslipidemia, and hypertension Take any supplements or antibiotics during the previous 3 months E88.81 Metabolic syndrome Treatment - Other Treatment - Other Treatment - Other Treatment - Other The first intervention group will receive a daily oral powder enriched with 1 gram of curcumin for 8 weeks. Curcumin powder will be supplied by Karen Company. The second intervention group will receive 10 to 9 CFU-enriched oral powders (Lactobacillus rhamnosus and Lactobacillus acidophilus) daily for 8 weeks. Probiotics will be provided by Parsi Lact Company. The third intervention group will receive daily oral powder enriched with 1 gram of curcumin and 10 to 9 CFU probiotics for 8 weeks. Curcumin will be supplied by Karen Company and probiotics will be supplied by Parsi Lact Company. The control group will receive placebo oral powder daily for 8 weeks. Placebo powder will be supplied by Parsi Lact Company. Leptin hormone. Timepoint: Before the study and 8 weeks after the start of the study. Method of measurement: Leptin kit (ELISA). Ghrelin hormone. Timepoint: Before the study and 8 weeks after the start of the study. Method of measurement: Ghrelin kit (ELISA). Appetite. Timepoint: Before the study and 8 weeks after the start of the study. Method of measurement: Visual Analog Scale (VAS) questionnaire. Weight. Timepoint: Before the intervention and 8 weeks after the start of the intervention. Method of measurement: Scale. Waist circumference. Timepoint: Before the intervention and 8 weeks after the start of the intervention. Method of measurement: Inelastic tape. Body fat percentage. Timepoint: Before the intervention and 8 weeks after the start of the intervention. Method of measurement: Body analyzer device. Shiraz University of Medical Sciences Approved 2022-01-30 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand Ave Shiraz Fars Iran (Islamic Republic of)