Flaxseed Consumption on Biochemical and Quality of Life in Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Flaxseed, Diet.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus (T2DM). Basic parameters: 19 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Flaxseed Consumption on Biochemical Parameters and Quality of Life in Patients With Type 2 Diabetes
Overview
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.
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.
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 outcome measures
- Evaluation of the effect of flaxseed on fasting blood glucose (mg/dL) [Time frame: 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]
- Evaluation of the effect of flaxseed on total triglyceride (mg/dL) [Time frame: 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]
- Evaluation of the effect of flaxseed on HDL-cholesterol (mg/dL) [Time frame: 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]
- Evaluation of the effect of flaxseed on quality of life [Time frame: From enrollment to the end of intervention at 12 weeks]
Secondary outcome measures (3)
- Evaluation of the effect of flaxseed on BMI (kg/m2) [Time frame: 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]
- Evaluation of the effect of flaxseed on waist/hip ratio [Time frame: From enrollment to the end of intervention at 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06911060 · BAP08-2025-5797 · BAP08-2025-5797