The Effect of Flaxseed Consumption on Biochemical Parameters and Quality of Life in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 主要终点
- Evaluation of the effect of flaxseed on fasting blood glucose (mg/dL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evaluation of the effect of flaxseed on fasting blood glucose (mg/dL)
时间窗: From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on LDL-cholesterol (mg/dL)
时间窗: From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on HbA1c (%)
时间窗: From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on total triglyceride (mg/dL)
时间窗: From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on quality of life
时间窗: From enrollment to the end of intervention at 12 weeks
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.
Evaluation of the effect of flaxseed on total cholesterol (mg/dL)
时间窗: From enrollment to the end of intervention at 12 weeks
Evaluation of the effect of flaxseed on HDL-cholesterol (mg/dL)
时间窗: From enrollment to the end of intervention at 12 weeks
次要结局
- 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)
研究者
YASEMİN ERTAŞ ÖZTÜRK
Assist. Prof.
Ondokuz Mayıs University