Flaxseed Consumption on Biochemical and Quality of Life in Type 2 Diabetes

NCT ID: NCT06911060

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-05-12

Brief Summary

The main goal of this clinical trial is to determine the effect of flaxseed added to the diet on biochemical parameters and quality of life in patients with Type 2 diabetes mellitus (T2DM). The main questions it aims to answer are:

• Does flaxseed supplementation given to T2DM patients for 12 weeks have an effect on biochemical parameters?
• Does flaxseed supplementation given to T2DM patients for 12 weeks have an effect on quality of life?

Researchers will compare patients with T2DM consume diet added flaxseed to a control group to see if flaxseed effect on biochemical parameters and quality of life.

Participants will:

• Complete the questionnaire, record the 3-day food consumption and be taken the anthropometric measurements at the beginning and end of the study.
• Take diet added 30 g ground flaxseed (intervention group) or only diet (control group) every day for 12 weeks.
• Visit the clinic once every 4 weeks for follow-up.
• Report the dietary adherence and gastrointestinal symptoms on a phone call once every week.

Detailed Description

Adult individuals between the ages of 19-65, with a body mass index (BMI) between 20-35 kg/m2, using oral anti-diabetics and not using insulin will be included in the study. Patients with T2DM who agree to participate in the study will be randomly assigned to the intervention or control group using the simple randomization method. Participants will be followed for 12 weeks. Both groups will receive diet as part of T2DM treatment. Subjects in the intervention group will consume 30 g of ground flaxseed per day in addition to their diet. The participants were asked by the researchers through a face-to-face interview technique to determine their demographic characteristics (age, marital status, education level, employment status, income level, etc.), quality of life short form (SF-36) scale, international physical activity questionnaire (IPAQ) and 3-day food consumption record. A survey form questioning consumption records will be applied at the baseline and end of the study. In addition, routinely monitored biochemical parameters of the patients will be recorded from the hospital system at the baseline and end of the study. Anthometric measurements will be taken and recorded by the researcher in accordance with the method. The data obtained will be evaluated in the SPSS package program.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Diet+Flaxseed

Diet will be planned to patients with T2DM as a part of their medical nutritional therapy. This group will take 30 g/d ground flaxseed within their diet.

Group Type: EXPERIMENTAL

Flaxseed

Intervention Type: DIETARY_SUPPLEMENT

30 g/day for 12 weeks

Diet

Intervention Type: BEHAVIORAL

Diet will be planned to patients with T2DM as a part of their medical nutrition therapy.

Diet

Diet will be planned to patients with T2DM as a part of their medical nutritional therapy.

Group Type: EXPERIMENTAL

Diet

Intervention Type: BEHAVIORAL

Diet will be planned to patients with T2DM as a part of their medical nutrition therapy.

Interventions

Flaxseed

30 g/day for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Diet

Diet will be planned to patients with T2DM as a part of their medical nutrition therapy.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosed with T2DM by a physician
• Being between the ages of 19-65
• Having a body mass index (BMI) between 20-35 kg/m2
• Using oral anti-diabetics and not using insulin

Exclusion Criteria

• History of gastrointestinal diseases
• High consumption of nuts, flaxseeds or sesame seeds (more than one serving per day)
• Food allergies or intolerances
• Malignancies
• Renal failure, liver, other endocrine or inflammatory disorders
• Use of lipid-lowering drugs
• Smoking and alcohol use
• Being pregnant or lactating

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

YASEMİN ERTAŞ ÖZTÜRK

Assist. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

BAP08-2025-5797

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BAP08-2025-5797

Identifier Type: -

Identifier Source: org_study_id