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NCT06911060
Flaxseed Consumption on Biochemical and Quality of Life in Type 2 Diabetes
Conditions: Type 2 Diabetes Mellitus (T2DM)
Sex: All
Ages: 19 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 46
Sponsor: Ondokuz Mayıs University
Location: Omü Suvam Samsun
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06911060). StuddyBuddy aggregates publicly available trial information.