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

August 9, 2025 updated by: YASEMİN ERTAŞ ÖZTÜRK, Ondokuz Mayıs University

The Effect of Flaxseed Consumption on Biochemical Parameters and Quality of Life in Patients With Type 2 Diabetes

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: Flaxseed
30 g/day for 12 weeks
Behavioral: Diet
Diet will be planned to patients with T2DM as a part of their medical nutrition therapy.
Experimental: Diet
Diet will be planned to patients with T2DM as a part of their medical nutritional therapy.
Behavioral: Diet
Diet will be planned to patients with T2DM as a part of their medical nutrition therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the effect of flaxseed on fasting blood glucose (mg/dL)
Time Frame: From enrollment to the end of intervention at 12 weeks
From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on HbA1c (%)
Time Frame: From enrollment to the end of intervention at 12 weeks
From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on total triglyceride (mg/dL)
Time Frame: From enrollment to the end of intervention at 12 weeks
From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on total cholesterol (mg/dL)
Time Frame: From enrollment to the end of intervention at 12 weeks
From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on HDL-cholesterol (mg/dL)
Time Frame: From enrollment to the end of intervention at 12 weeks
From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on LDL-cholesterol (mg/dL)
Time Frame: From enrollment to the end of intervention at 12 weeks
From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on quality of life
Time Frame: From enrollment to the end of intervention at 12 weeks
Quality of life will be assessed with SF-36. The total score is evaluated separately into two summary scores: the physical component summary (PCS12) and the mental component summary (MCS12). The score of the answers related to the PCS12 is obtained from the factors of general health, role-physical, physical functioning, and bodily pain, and the score of the answers related to the MCS12 is obtained from the factors of social functioning, role-emotional, mental health, and energy/fatigue. Both scores range from 0 to 100, with a higher score representing better health.
From enrollment to the end of intervention at 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the effect of flaxseed on BMI (kg/m2)
Time Frame: From enrollment to the end of intervention at 12 weeks
From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on waist circumference (cm)
Time Frame: From enrollment to the end of intervention at 12 weeks
From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on waist/hip ratio
Time Frame: From enrollment to the end of intervention at 12 weeks
From enrollment to the end of intervention at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 12, 2026

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

August 12, 2025

Last Update Submitted That Met QC Criteria

August 9, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAP08-2025-5797 (Other Grant/Funding Number: Ondokuz Mayıs University Scientific Research Project)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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