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NCT Number: NCT06911060

Flaxseed Consumption on Biochemical and Quality of Life in 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.

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Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flaxseed

Dietary Supplement

30 g/day for 12 weeks

Diet

Behavioral

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

Primary outcomes

  1. Evaluation of the effect of flaxseed on fasting blood glucose (mg/dL)

    Time frame: From enrollment to the end of intervention at 12 weeks

  2. Evaluation of the effect of flaxseed on HbA1c (%)

    Time frame: From enrollment to the end of intervention at 12 weeks

  3. Evaluation of the effect of flaxseed on total triglyceride (mg/dL)

    Time frame: From enrollment to the end of intervention at 12 weeks

  4. Evaluation of the effect of flaxseed on total cholesterol (mg/dL)

    Time frame: From enrollment to the end of intervention at 12 weeks

  5. Evaluation of the effect of flaxseed on HDL-cholesterol (mg/dL)

    Time frame: From enrollment to the end of intervention at 12 weeks

  6. Evaluation of the effect of flaxseed on LDL-cholesterol (mg/dL)

    Time frame: From enrollment to the end of intervention at 12 weeks

  7. 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.

Secondary outcomes

  1. Evaluation of the effect of flaxseed on BMI (kg/m2)

    Time frame: From enrollment to the end of intervention at 12 weeks

  2. Evaluation of the effect of flaxseed on waist circumference (cm)

    Time frame: From enrollment to the end of intervention at 12 weeks

  3. Evaluation of the effect of flaxseed on waist/hip ratio

    Time frame: From enrollment to the end of intervention at 12 weeks

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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