The effect of date seed powder supplementation on nutritional status, metabolic, oxidative stress and inflammatory parameters in diabetes type 2 patients

Determining The effect of date seed powder supplementation on nutritional status, metabolic, oxidative stress and inflammatory parameters in diabetes type 2 patients

This Randomized, three-blind study to determine the effects of date seed powder supplementation on patients with type 2 diabetes will be done. Patients were randomly divided into two groups with 21 paticipants based on a block randomization procedure of size six by using random allocation software (RAS). Each block involves patients with the same categories of BMI and age.

This randomized, three- blind clinical trial will be performed on T2DM patients from the Iran Diabetes Society and Hospitals of Kerman University of Medical Science.

Inclusion criteria included having at least 6 months of history of diabetes, age range 30 to 50 years, BMI between 25 to 30 and no weight changes during the last 3 months, no insulin therapy and use of antihypertensive drugs, propensity to take Date seed powder during the study and exclusion criteria include the use of insulin therapy, specific medications, receiving antioxidant supplements at least three months before the start of the study, a history of weight loss diet during the last 6 months or special diet, the presence of disease or Impairment, alcohol or smoking, pregnancy, lactation, being an athlete, strenuous physical activity and unwillingness to consume palm seed powder and gastrointestinal symptoms during the study.

The intervention group will receive 5 grams of date seed powder daily for 8 weeks.

Glycemic markers (insulin, HbA1c, fasting blood sugar), lipid profile, anti-inflammatory markers (TNF-α, hs-CRP), oxidative stress and antioxidant markers

No changes have been made in the protocol of the present study, and only some parameters have been added. According to the comprehensive review on registered trial, all the added parameters along with the recorded parameters were presented as a comprehensive study in this field. Unfortunately, before registering this project in the Iranian Registry of Clinical Trials due to financial constraints, some of the considered parameters were removed. Recently, due to the funding of the project via top researchers grant, researchers have re-added the deleted parameters to the project for a comprehensive study in this field.

At baseline, eligible individuals will be matched for BMI and age according to the classification of these variables. Individuals will be randomly divided into two groups, the intervention group (n=21, receiving date seed powder) control (n=21, receiving Maltodextrin) using RAS software into 2 and 4 blocks, and will be given codes 1 and 2.

After randomization, both groups will be given date seed powder and maltodextrin that encoded in sachets weighing 2.5 g in similar packages (metalized) without the researcher intervention and coded with codes 1 and 2. Until releasing of study results, the patient, the researcher, and the data analyzer will not be aware of the assigned codes. Therefore, the study will be three-blind

Participant data will be presented in the article without identifiable details

2022-2023

Tabriz University of Medical Sciences

The application must be submitted to Tabriz University of Medical Sciences. It will available if Tabriz University of Medical Sciences is allowed.

Tabriz University of Medical Sciences

The application must be submitted to Tabriz University of Medical Sciences. It will available if Tabriz University of Medical Sciences is allowed.