The effects of Flaxseed oil supplementation on inflammatory markers in overweight pre-diabetes patients

Determine the effect of flax seed oil supplement on inflammatory indexes in overweight pre-diabetes patients

In this study, 80 pre-diabetic and eligible patients who are referred to the Isfahan Cardiovascular Center are selected. Participants are randomly divided into two intervention and control groups and each participant is given an assigned code.

This is a double-blind, randomized controlled clinical trial of overweight pre-diabetic individuals referred to the Isfahan Cardiovascular Center.  At the beginning of the study, general information questionnaire including age, height, weight, occupation, history of disease, type and dosage of consumable drugs are completed. Then, the subjects were randomly divided into two groups and consumed flaxseed oil (1 g, 2 times a day) and placebo (1 g, 2 times a day) for 14 weeks. Serum samples of the participants in the study were collected at the beginning and the end of the study by blood sampling and centrifugation. At the end of the study, was used to measure hs-CRP and TNFα. Participants will receive special codes for the control and intervention group that the investigator and the participants do not know about the type of intervention of each individual.

The inclusion criteria included people with impaired fasting glucose, fasting blood sugar of between 100 and 125 mg / dl, and body mass index of between 25 and 29/9. Exit criteria From the study included Receiving oral hypoglycaemic drugs (sulfonylurea, magnetlonid, bialuanides, thiazolidinedione, alpha-glucosidase inhibitors, DPP-4 inhibitors, SGLT2 inhibitors and insulin injections, any type of acute and chronic disease other than impaired glucose tolerance which affect on The metabolism of glucose or uncontrolled, any kind of susceptibility or intolerance to flaxseed oil, smoking, having severe activity, and an unusual diet (more than 150 minutes of moderate aerobic activity per week or 75 minutes of aerobic activity with intensity Highly in the week, removing one or more food groups from the daily diet), women with Having a monthly cycle for at least the past 6 months, using basic anti-inflammatory drugs (steroidal and non-steroidal anti-inflammatory drugs), consuming regularly, flaxseed or fish oil supplements (one-time use or more per week for a fixed dose), and The consumption of fish is more than 340 grams per week and soy consumption is fixed at once or more than once a week

The subjects in the intervention group will receive flaxseed oil supplement (two 1000-mg capsules per day, Barij Essence Co., Kashan) for 14 weeks. On the other hand, the subjects in the control group will take a placebo similar to the compound of the other group, which contained oral paraffin (two 1000-mg capsules per day).

TNFα; hs-CRP

Yazd University of Medical Sciences

Using the randomized code obtained from the computer

No external person was involved in the preparation of a randomized list, nor in the counting and packaging of capsules. All participants in this study (patients, health care provider) were unaware of the outcome of the treatment.

Data report will be shared after publishing the paper.

Six months after publish

Academic researchers

Using for Meta-analysis

Center nutrition, public health, univercity of medical sciencies yazd Tel: 009835 31492239 Email: azadehnajarzadeh@gmail.com Azadenadjarzadeh

It will be sent two weeks after the receipt of the email with the consent of the co-workers.