Evaluation of the effect of oral oleoylethanolamide (OEA) supplement on glycemic indexes, insulin resistance and C-reactive protein in pre-diabetic patients: A double-blind controlled clinical trial with placebo

Determining the effect of Oleoylethanolamide oral supplementation on the glycemic index, insulin resistance, and C-reactive protein in pre-diabetic patients

In this study, 44 patients with prediabetes who are eligible for inclusion in the study and referred to the Department of Endocrinology and Metabolism of Velayat Hospital of Qazvin University of Medical Sciences are selected. Participants are randomly assigned to two intervention and control groups and each participant is assigned a code.

This study will be done by referring to the Specialty Hospital of Qazvin University of Medical Sciences. The intervention and control group will receive 125 mg of Oleoylethanolamide or placebo daily for 2 months, respectively. Each person will complete questionnaires of individual consent, physical activity, and 24-hour recall. Fasting blood samples were also collected at the beginning and end of the study in 10 ml from participants. In this study, participants will be randomly divided into two groups (22 persons) through the table of random numbers.

Inclusion criteria: willingness to work, prediabetes, age 25- 55, non-modification of treatment and medications for at least the past 2 months, moderate physical activity Exclusion criteria: Pregnancy and lactation, patients with severe renal and hepatic dysfunction, alcohol consumption

Intervention group: the group receiving Oleoylethanolamide (125 mg daily) Control group: placebo group

Fasting blood sugar, 2 hours sugar, Glycosylated hemoglobin, insulin resistance, an inflammatory factor

Participants will be allocated to trial groups (intervention and placebo groups) randomly using Random Allocation Software (RAS) through random block sizes of 4 and 6 with an allocation ratio of 1:1. Patients will receive a sealed container of supplements. Random sequencing allocation will be produced by the person who has not participate in the research. Containers will be numbered from 1 to 44 according to the sequence generated.

Supplements and placebo will be placed in similar containers and encode by someone except the investigator, so patients and the investigator will be blinded to medicine and placebo groups.

All data after people are unrecognizable

After completing the study and analyzing the data

All researchers

There is no objection to the use of data provided the source of the resource.

By contacting the email address of a person responsible for general inquiries khademnut@yahoo.com

Six months after the study