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IRCT20191105045340N7 IRCT 2025-07-22 Iran University of Medical Sciences The effect of probiotics and curcumin in patients with type 2 diabetes "The effect of probiotics and curcumin on glycemic and insulin status and oxidative stress in patients with type 2 diabetes: a triple-blind clinical trial" 2025-09-01 anticipated 92 Complete https://irct.ir/trial/84459 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of dividing participants into different groups is as follows: after meeting the conditions, participants are randomly divided into four groups A, B, C and D. This division is done using the random block method. To generate the random sequence in this trial, the random block method with a fixed or variable block size is used to ensure equal distribution of participants in the groups. The sequence of allocation of participants is generated using specialized software such as Random Allocation Software or statistical packages such as STATA or R (blockrand function in R). The resulting sequence is stored in an encrypted file and will be maintained and executed by an independent person who is not involved in the data collection process. Drug companies will be responsible for manufacturing placebos, which are similar in appearance to the drugs, and they will also be asked to randomly place the letters A or B on the drug or placebo and the other letter on the other, Blinding description: This interventional study will be conducted in a triple-blind manner. Blinding will include the patient, therapist, and analyst. Drug companies will manufacture placebos that are identical in appearance to the drugs and will also be asked to randomly label one drug or placebo with the letter A or B and the other with the letter B. The type of drug and placebo will be kept confidential until the end of the data analysis. After the analysis, the researcher will ask the drug manufacturer for the type of labels. This means that the therapist will not know whether the drug or placebo is in the drug package. The patient and analyst will also not be aware of this. The placebo capsules will be identical in appearance, color, and smell to the capsules in the intervention group. 3 Type 2 diabetes. Intervention 1: Intervention group: They receive one daily probiotic supplement capsule with a dose of 109 CFU (Zist Fermentation Company) (Food and Drug Supplement IRCT code: 5299398045382901) along with a curcumin placebo;. Intervention 2: Intervention group: They take one 500 mg capsule of curcumin (Karen Company) (IRCT code is 1058067011726337) daily along with a probiotic supplement;. Intervention 3: Intervention group: They receive one probiotic capsule daily along with one 500 mg curcumin capsule. Intervention 4: Control group: Will receive placebo for both supplements. 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 further information
public Seyedeh Tayebeh Rahideh
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4843 rahide.t@iums.ac.ir Iran University of Medical Sciences scientific Seyedeh Tayebeh Rahideh
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4843 rahide.t@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age: Patients between 30 and 65 years. Diagnosis of type 2 diabetes: Patients with type 2 diabetes who have had the disease for at least 6 months and have been confirmed by an endocrinologist Body mass index (BMI) in the range of 25 to 35 kg/m2.4. HbA1C range between 6.5% and 9% No supplements: No use of vitamin, mineral or antioxidant supplements and pro- and pre-supplements in the past month. Stable medical condition: Patients who have a stable medical condition and their main medications have not changed in the past month. 30 years 65 years Both Comorbidities: Severe renal, hepatic, cardiovascular, cancer, or other disorders. Insulin injections Pregnant or breastfeeding women. Allergy to interventions: History of allergy to probiotics, turmeric, or curcumin. Occurrence of digestive problems due to the intervention (including reflux) Use of antibiotics in the 14 days prior to the start of the intervention Unwillingness to continue the study: voluntary withdrawal of the patient or failure to cooperate in taking supplements or providing samples. E11 Type 2 diabetes mellitus Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group: They receive one daily probiotic supplement capsule with a dose of 109 CFU (Zist Fermentation Company) (Food and Drug Supplement IRCT code: 5299398045382901) along with a curcumin placebo; Intervention group: They take one 500 mg capsule of curcumin (Karen Company) (IRCT code is 1058067011726337) daily along with a probiotic supplement; Intervention group: They receive one probiotic capsule daily along with one 500 mg curcumin capsule. Control group: Will receive placebo for both supplements Fasting blood sugar (FBS) level. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Blood test. Serum insulin. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Blood test. Malondialdehyde level. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Blood test. Total antioxidant capacity (TAC). Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Blood test. HbA1c. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Blood test. Homeostatic insulin resistance index (HOMA-IR). Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Calculated from fasting glucose and insulin levels using the formula (Fasting Glucose (mg/dL) * Fasting Insulin (mU/L)) / 405. Iran University of Medical Sciences Approved 2025-06-09 Research Ethics Committees of School of Public Health -Iran University of Medical Sciences Management of Research Development and Evaluation, Deputy of research and technology, next to Milad Tower, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)