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

NCT06911060 | Not Yet Recruiting

• 1 other identifier: BAP08-2025-5797
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Type 2 diabetes mellitus; flaxseed; quality of life; glycemic control

Outcome Measures

Primary Outcomes (7)

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

  From enrollment to the end of intervention at 12 weeks

• Evaluation of the effect of flaxseed on HbA1c (%)

  From enrollment to the end of intervention at 12 weeks

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

  From enrollment to the end of intervention at 12 weeks

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

  From enrollment to the end of intervention at 12 weeks

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

  From enrollment to the end of intervention at 12 weeks

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

  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.

  From enrollment to the end of intervention at 12 weeks

Secondary Outcomes (3)

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

  From enrollment to the end of intervention at 12 weeks

• Evaluation of the effect of flaxseed on waist circumference (cm)

  From enrollment to the end of intervention at 12 weeks

• Evaluation of the effect of flaxseed on waist/hip ratio

  From enrollment to the end of intervention at 12 weeks

Study Arms (2)

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.

Dietary Supplement: Flaxseed; Behavioral: Diet

Diet

EXPERIMENTAL

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

Behavioral: Diet

Interventions

Flaxseed DIETARY_SUPPLEMENT

30 g/day for 12 weeks

Diet+Flaxseed

Diet BEHAVIORAL

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

Diet; Diet+Flaxseed

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linseed Oil; Diet

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 4, 2025
• Study Start: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): May 12, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08