Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT06911060
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-12
First Post:
2025-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flaxseed Consumption on Biochemical and Quality of Life in Type 2 Diabetes
Sponsor:
Ondokuz Mayıs University
Organization:
Study Overview
Official Title:
The Effect of Flaxseed Consumption on Biochemical Parameters and Quality of Life in Patients With Type 2 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| BAP08-2025-5797 | OTHER_GRANT | Ondokuz Mayıs University Scientific Research Project | View |