Evaluation of the Antidiabetic Effect of Dietary Supplement( Denazh supplement) Prepared from Oat and Terminalia chebula fruit in Patients with Prediabetes Type 2 Diabetes: A Single-Blind Clinical Trial

The aim of this study is to compare the effects of Terminalia chebula extract and Terminalia chebula powder combined with oat powder versus placebo on glycemic control indices and lipid profile in individuals with prediabetes.

This study is a randomized, placebo-controlled, three-arm, parallel-group, single-blind clinical trial conducted among 75 participants with prediabetes typ 2

This randomized, placebo-controlled, three-arm, parallel, single-blind clinical trial will be conducted among 75 individuals with prediabetes at the 501 Army Hospital in Tehran. Participants will be randomly assigned to receive placebo, black myrobalan (Terminalia chebula) powder, or black myrobalan extract, with the latter two formulations combined with oat powder. They will consume one 6-g sachet daily for 6 weeks. Blood glucose and lipid profiles will be assessed before and after the intervention.

Diagnosis of type 2 prediabetes prior to enrollment in the study Fasting blood glucose greater than 100 and less than 125 Age between 18 and 70 years Willingness to participate in the study and signing of the informed consent form

Control group (placebo): Participants receive one 6-g sachet of a placebo daily, matched in appearance and taste, with minimal potential effects on glycemic and lipid parameters. Intervention group 1: Participants receive one 6-g sachet daily containing Terminalia chebula powder and oat powder. Intervention group 2: Participants receive one 6-g sachet daily containing Terminalia chebula extract and oat powder.

Primary outcomes The primary outcomes of the study were: Fasting blood sugar (FBS) Fasting insulin Insulin resistance index (HOMA-IR) The insulin resistance index was calculated based on fasting blood sugar and fasting insulin values.

Randomization method: In this study, randomization will be performed individually using block randomization to ensure that the number of participants in each group remains as balanced as possible throughout the allocation process. Statistical software will be used to generate the random sequence. If necessary, blocks of variable sizes may be used to reduce the predictability of allocation. Unit of randomization: The unit of randomization is the individual participant. Stratification variables: Stratified randomization will not be used in this study. Randomization tool: The random sequence will be generated using statistical software, and participants will be allocated to groups based on this sequence. Method of generating the random sequence: A pre-specified random sequence will be generated by an individual independent of the study implementation team. This sequence will be designed based on random blocks and will be used sequentially to allocate participants to the study groups. Allocation concealment: To prevent allocation bias, the random sequence and group allocation information will be concealed from researchers and assessors until the participant enters the study and completes the registration process. Final allocation will be performed by an independent individual using an appropriate allocation concealment methodent: To prevent allocation bias, the random sequence and group assignments will be kept concealed from researchers and assessors until the participant enters the study and the registration process is completed. Final allocation will be performed by an independent person using an appropriate concealment method.

Description of study blinding: This study has been designed as a single-blind study. In order to comply with the principles of medical ethics, all participants will be fully informed about the nature of the study, the research process, and its purpose before entering the study, and will sign a written informed consent form. Blinding is limited to concealing the type of intervention (black myrobalan, black seed, or placebo) from the participants. Details of the blinding status of individuals are as follows: Participants: Participants will be unaware of their allocation to the intervention groups (black myrobalan, black seed, or placebo), and the supplements will be prepared to be similar in appearance, color, odor, and packaging. However, participants will be fully aware of the general nature of the study and that they are receiving either a type of herbal supplement or a placebo. Principal investigator and research team: The principal investigator, healthcare personnel, and those responsible for implementing the study will be aware of group allocations in order to monitor patient safety and manage potential adverse events.