Recruiting

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

ClinicalTrials.gov IDNCT06911060

PhaseNA

Enrollment46

SponsorOndokuz Mayıs University

Age19 Years – 65 Years

SexALL

I'm interested View official listing

Conditions studied

Type 2 Diabetes Mellitus (T2DM)

About this study

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.

Interventions

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.

Primary outcomes

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 (From enrollment to the end of intervention at 12 weeks)

Eligibility information

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 locations

Omü Suvam, Samsun, Turkey (Türkiye)

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-27.