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IRCT20190531043776N1 IRCT 2019-10-13 Shiraz University of Medical Sciences Effect of kefir after bariatric surgery Comparison of the Effectiveness of Kefir and Yogurt on Antropometric and Metabolic Parameters, Vaspin, Metabolic Endotoxemia and Appetite in Patients undertake Bariatric Surgery and follow up of Weight Change, Body Shape Conception, Food Intake and Appetite in Patients after Completing the Intervention Phase 2019-09-06 anticipated 48 Complete https://irct.ir/trial/41814 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Patients included in this study will be unaware that they are in the yogurt recipient group or in the kefir recipient group. On the other hand, due to the similarity of appearance of both products in the packages of similar appearance and with the same label given to the participants, it has been tried to blind the patients. But other people involved in the process know how to classify intervention and control groups. N/A Bariatric surgery, gastric bypass surgery. Intervention 1: Intervention group: Patients in the intervention group, 14 days after surgery, will receive 100 grams of low-fat kefir pasteurized yogurt daily for 8 weeks daily, in addition to dietary recommendations and specific dietary plans. The yogurt will be distributed to patients every two weeks. Kefir yogurt will be purchased from the Kalleh Dairy Co. (PJS.), which is classified into probiotic products, and in addition to the beneficial bacteria contained the Saccharomyces cervisae yeast . Intervention 2: Control group: Patients in the control group received 100 grams of pasteurized yogurt daily, in addition to dietary recommendations and diet similar to the intervention group, on the 15th day after surgery for 8 weeks. The yogurt will be distributed to patients every two weeks and the calorie intake of kefir yogurt will be balanced against yogurt. This yogurt will also be purchased from the Kalleh Dairy Co. (PJS.), the main difference between the control and the intervention being the kefir starter in the intervention group, in other word, the control group will consume only fermented product but the intervention group will receive a fermented starter-based probiotic product. 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 No more information.
public Reyhane Basirat
School of Nutrition and Food Sciences, Razi s.t, Shiraz, Iran.
Shiraz Iran (Islamic Republic of) 7153675541 +98 71 3725 1001 r.basirat@yahoo.com Shiraz University of Medical Sciences scientific Reyhane Basirat
School of Nutrition and Food Sciences, Razi Blvd, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7153675541 +98 71 3725 8099 basirat@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) BMI more than 40 or more than 35 with comorbidity diseases Patients undergoing bariatric surgery 20 years 60 years Both More than 10 days after surgery Chronic gastrointestinal diseases and liver Gastrointestinal infection after surgery and receiving antibiotics Long-term hospitalization after surgery (more than 10 days) E66.01 Morbid (severe) obesity due to excess calories Treatment - Other Treatment - Other Intervention group: Patients in the intervention group, 14 days after surgery, will receive 100 grams of low-fat kefir pasteurized yogurt daily for 8 weeks daily, in addition to dietary recommendations and specific dietary plans. The yogurt will be distributed to patients every two weeks. Kefir yogurt will be purchased from the Kalleh Dairy Co. (PJS.), which is classified into probiotic products, and in addition to the beneficial bacteria contained the Saccharomyces cervisae yeast . Control group: Patients in the control group received 100 grams of pasteurized yogurt daily, in addition to dietary recommendations and diet similar to the intervention group, on the 15th day after surgery for 8 weeks. The yogurt will be distributed to patients every two weeks and the calorie intake of kefir yogurt will be balanced against yogurt. This yogurt will also be purchased from the Kalleh Dairy Co. (PJS.), the main difference between the control and the intervention being the kefir starter in the intervention group, in other word, the control group will consume only fermented product but the intervention group will receive a fermented starter-based probiotic product. Weight loss. Timepoint: At baseline, 4, 8, and 16 weeks after intervention. Method of measurement: Digital Scale. Body composition. Timepoint: At baseline and 8 and 16 weeks after the intervention. Method of measurement: body composition measuring device Inbody. Vaspin. Timepoint: At baseline and And 8 weeks after intervention. Method of measurement: Serum level by Kit ELISA. Lipopolysaccharide. Timepoint: At baseline and And 8 weeks after intervention. Method of measurement: Serum level by Kit ELISA. Shiraz University of Medical Sciences Approved 2018-12-25 Ethics committee of Shiraz University of Medical Sciences School of Nutrition and Food Sciences, Razi Blvd, Shiraz Shiraz Fars Iran (Islamic Republic of)