Effect of red beetroot on metabolic factors in subjects with pre-diabetes

To examine the effect of consuming red beetroot powder on metabolic factors in people with pre-diabetes.

Clinical trial with a control group and parallel design, double-blind, randomized, phase 3 on 74 patients. The WinPepi software was used for randomization.

Beetroot has the potential to be effective and therapeutic in people with pre-diabetes. People with pre-diabetes who refer to Isfahan Endocrine and Metabolism Research Center and meet the inclusion criteria will be invited to participate in this research. After obtaining informed consent, people will be asked to refer to the Endocrine and Metabolism Research Center in a fasting state of at least 8 hours during their next visit (first visit), and fasting and two-hour blood glucose samples, as well as blood and urine samples necessary for Biochemical measurements will be collected. Besides, information on anthropometrics, demographics, blood pressure, general characteristics, food intake and physical activity will be collected. At the end of week 12 (second visit), all measurements from the first visit will be repeated. During the study, the participants, the trained questioner, and the outcome examiner will be blinded to the type of intervention. For blinding, the sachets of both intervention and placebo groups will be identical in terms of shape, color, weight and other physical characteristics.

Inclusion criteria: people with prediabetes aged 20-80 years old. Non-Inclusion criteria: use of any anti-diabetic agent except metformin; pregnant or lactating women.

Intervention: Red beetroot powder. Placebo: Rice powder

Main outcomes: 2-hour blood glucose level; fasting blood sugar; fasting insulin; hemoglobin A1C; homeostatic model assessment for insulin resistance; the quantitative insulin-sensitivity check index

In this study, the participants are randomly assigned to two groups of consuming beetroot powder (intervention) or placebo group. For randomization, the WinPepi software was used and the participants of each group (intervention and placebo) were placed in two strata (metformin users and non-users). The number of participants in each stratum was determined based on the prevalence of metformin use in prediabetic people. In the output of the software, the sequence of participants in two strata was determined, and in each stratum, the participants have been assigned to the intervention or placebo group. After randomization, the list of generated codes was deleted.

For blinding, intervention sachets will be similar to placebo sachets in terms of shape, texture, color, weight, and other physical characteristics. The intervention sachets contain beetroot powder and the placebo sachets contain rice powder, which has been prepared at the same color as the beetroot powder using an approved food color.

All data from this research can be shared after de-identifying individuals.

3 months after the results are published.

All researchers.

Data requests will be considered only after the publication of results.

The main research executor: Elham Hosseini E-mail address: hosseini@res.mui.ac.ir

After the publication of the results, people intending to use data collected in this research can make their request by submitting their proposal to the main executor. If the proposal is accepted by the executor, the data will be provided to the requester.