The effects of rutin flavonoid supplement consumption on blood pressure, heart rate, quality of life and some serum antioxidant enzymes in type 2 diabetic patients

The effects of rutin flavonoid on type 2 diabetes mellitus

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 48 patients. For randomization, block design is used.

Referred to the endocrine clinic of Golestan Hospital of Ahvaz in 2021, selection of 48 patients based on inclusion and exclusion criteria, randomization into intervention and control groups. Blinding of patients and researchers, coding by a third party who does not know the details.

Inclusion: Willingness to participate in the study People between 20 to 60 years old in both sexes, Over at least 2 years from time of diagnosis of type 2 diabetes mellitus Body mass index (BMI) less than 35 (BMI ≤ 35) Glycosylated hemoglobin (HbA1c) between 6.5 to 11% Exclusion: Developing complications from diabetes such as renal failure Diabetic patients taking insulin Thyroid disease Anemia Pregnancy, lactation Smokers Use of other dietary supplements, probiotics and anti-inflammatory drugs Use of any antioxidant supplements in the last 3 months Use of immunosuppressive drugs Following of special diets other than the diet specific to diabetic patients,

Intervention group: Every day, one tablet of 1 g rutin (containing 500 mg of pure rutin and 500 mg other compounds include di-calcium phosphate, microcrystalline cellulose, plant cellulose, stearic acid, magnesium stearic, silica, glycerin), after meals for 90 days. Control group: One tablet of 1 g placebo/day (containing compound similar to supplement except rutin), after meals for 90 days.

Systolic and diastolic blood pressure, pulse pressure, mean arterial pressure, heart rate, quality of life, serum levels of catalase, superoxide dismutase and glutathione peroxidase

High prevalence of Covid 19 disease and the lack of sampling

Assignment of patients in each of the study groups (supplement or placebo) will be done by "Random allocation software" using classified randomized blocking method (block size: 4). In addition, in order to reduce selection bias error, allocation concealment will be used. This will be done by assigning unit codes (two codes A and B) to each patient's tablets. In this way, 48 patients will be randomly allocated to placebo (n = 24) or intervention (n = 24) groups. In fact, each patient will receive a can containing code A or B, and eventually 24 patients will receive cans containing code A and 24 patients will receive cans containing code B.

In the present study, the doctor, researcher, and patients will be blinded to the study groups. Before starting the study, the cans containing the respective tablets will be coded by a person other than the researcher (this person will not aware of the details of the research) to A and B, so that the type of received tablets in each group will be blinded for researcher. Also, placebo and supplement tablets will be similar in terms of color, shape, size and taste. In addition, cans containing the supplement and placebo will be quite similar.

The person's information will be confidential and the results will be as collective statistics

This clinical trial will be an research article and its results report and statistical analysis will be published to be used by therapists and researchers.

If the journal has requested access to the data at any time, the data will be provided.

Journal editors and Reviewers

Sometimes for re-analysis or for use in meta-analysis studies

Project manager

Mail to hadibazyar2015@gmail.com