"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"

Determining the effect of probiotic and curcumin supplementation on insulin status and glycemic indices in patients with type 2 diabetes

A clinical trial with a control group, parallel groups, triple blind, randomized on 92 patients.

The study will be conducted in a triple-blind (patient, therapist, and analyst) design at Imam Khomeini Hospital. The subjects' dietary intake will be assessed using a 24-hour food recall. Body composition, variables of interest, and 24-hour food recall questionnaires and the International Physical Activity Score will be assessed before and after the intervention. Nutrient analysis will be performed using N4 software.

Inclusion criteria included age between 30 and 65 years, patients with type 2 diabetes; BMI between 25 to 35 kg/m2; HbA1C between 6.5% and 9%; no use of vitamin, mineral or antioxidant and pro- and pre-supplements in the past month; and stable medical condition. Exclusion criteria included; having or having comorbidities, pregnancy or breastfeeding; insulin injection; history of sensitivity to probiotics, turmeric or curcumin; occurrence of gastrointestinal problems caused by the intervention; use of antibiotics in the 14 days before the start of the intervention; and unwillingness to continue the study.

The probiotic group will receive daily probiotic supplement with a dose of 10^9 CFU (Zist Takhmir Company) along with a curcumin placebo; the curcumin group will consume one daily 500 mg curcumin capsule (Karen Company) along with a probiotic placebo; the curcumin and probiotic combination group will receive one daily probiotic capsule along with one 500 mg curcumin capsule for 8 weeks. the control group will receive the placebo corresponding to both supplements.

Insulin status and glycemic indices in patients with type 2 diabetes

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.

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.