Type 2 Diabetes Mellitus (T2DM)NCT06911060

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

A study testing Flaxseed and Diet in people with Type 2 Diabetes Mellitus (T2DM), run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 19 to 65 years
Conditions the study is for: Type 2 Diabetes Mellitus (T2DM)
What is being tested?: Flaxseed and Diet
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 30 Sep 2025to 12 May 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting

Omü Suvam
Samsun
Yasemin ERTAŞ ÖZTÜRK, PhD, +903623121919 ext. 6370, yasemin.ertasozturk@omu.edu.tr
Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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)
Being tested: Flaxseed, Diet
Keywords: Type 2 diabetes mellitus, flaxseed, quality of life, glycemic control
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FlaxseedDietary supplement
30 g/day for 12 weeks
DietBehavioural
Diet will be planned to patients with T2DM as a part of their medical nutrition therapy.

Study groups in NCT06911060
Study group	Role	What they receive
Diet+Flaxseed	Experimental	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. Receives: Dietary Supplement: Flaxseed; Behavioral: Diet
Diet	Experimental	Diet will be planned to patients with T2DM as a part of their medical nutritional therapy. Receives: Behavioral: Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of the effect of flaxseed on fasting blood glucose (mg/dL)
Measured: From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on HbA1c (%)
Measured: From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on total triglyceride (mg/dL)
Measured: From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on total cholesterol (mg/dL)
Measured: From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on HDL-cholesterol (mg/dL)
Measured: From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on LDL-cholesterol (mg/dL)
Measured: From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on quality of life
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.
Measured: From enrollment to the end of intervention at 12 weeks

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 202512 May 2027

First posted4 Apr 2025
Study start30 Sep 2025
Primary completionMay 2027 (estimated)
Study completion12 May 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 46 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06911060
Sponsor's protocol ID: BAP08-2025-5797
Other IDs: BAP08-2025-5797
Status last verified: Oct 2026
First submitted: 12 Mar 2025
Last updated: 23 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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