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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 12, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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