Effects of Omega-3 Fatty Acid Supplementation on Serum Fetuin-A Levels in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Analysis of serum adiponectin (µg/mL)
研究概览
简要总结
Background and aims: One of the investigated possible modulators of serum fetuin-A, associated with the risk of developing coronary artery disease (CAD), is omega-3 fatty acids (FAs). This study aims to evaluate the effects of omega-3 FA supplementation on serum fetuin-A concentration in patients with CAD.
Methods: The study was carried out on 34 male volunteer patients aged 35-75 years, newly diagnosed with CAD by conventional coronary angiography. Patients with CAD were divided into the "Omega-3 Group (n:16)" and "Control Group (n:18)". Low-fat diet principles were explained to both groups at baseline. While 1.560 mg/day omega-3 FA supplementation was given to the patients in the omega-3 group for eight weeks, but not in the control group. Food intake was recorded using six-day food records.
详细描述
The study was carried out on 34 male volunteer patients aged 35-75 years, newly diagnosed with coronary artery disease (CAD) by conventional coronary angiography. The study did not include the individuals who have dieted in the last six months, been taking an omega-3 FA and/or vitamin/mineral supplements or statin group drugs, been BMI <18.5 and ≥40 kg/m2, been fasting blood glucose ≥ 126 mg/dL, had a systemic disease such as Type 1 and Type 2 diabetes, kidney diseases, liver diseases, cancer and neurological diseases, active athletes, regular exercisers. Gazi University Faculty of Medicine Clinical Research Ethics Committee approved the study on 26 November 2020 with approval number 810. In addition, the necessary approval was obtained from the Turkish Medicines and Medical Devices Agency with the decision numbered 66175679-514.11.01-E.290378. All participants gave signed informed consent and the study was conducted in accordance with Helsinki Declaration.
Patients with CAD were divided into the "Omega-3 Group (n:16)" and "Control Group (n:18)" to evaluate the effects of omega-3 FA supplementation on biochemical parameters, especially serum fetuin-A, anthropometric measurements, and nutritional status. 1.560 mg/day omega-3 FA supplementation was applied for 8 weeks to 16 participants with CAD included in the omega-3 group, and the principles of a low-fat diet were explained. The principles of the low-fat diet without omega-3 FA supplementation were explained to 18 participants with CAD in the control group. The data of the participants were collected at the beginning, every 15 days and at the end of the 8th week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male volunteer patients aged 35-75 years
- •Patients with newly diagnosed with coronary artery disease by conventional coronary angiography
排除标准
- •Individuals who have dieted in the last six months
- •Use of omega-3 fatty acid and/or vitamin/mineral supplements or statin group drugs
- •BMI <18.5 and ≥40 kg/m2
- •Fasting blood glucose ≥ 126 mg/dL
- •Presence of systemic diseases such as Type 1 and Type 2 diabetes, kidney diseases, liver diseases, cancer or neurological diseases
- •Active athletes and/or those who exercise regularly
结局指标
主要结局
Analysis of serum adiponectin (µg/mL)
时间窗: 8 weeks
The blood samples of the participants were taken by the nurse after 8 hours of fasting for the analysis of biochemical parameters. Adiponectin (µg/mL) concentrations in blood samples were analyzed in a private laboratory. For the analysis of adiponectin, blood samples taken into yellow-capped gel tubes were kept at room temperature for 30-45 minutes while the tubes were in an upright position, then centrifuged at 3,000 rpm for 15 min and the serum was frozen at -80°C until assayed.
Analysis of serum high-sensitivity troponin T (hs) -TnT) (ng/mL)
时间窗: 8 weeks
The blood samples of the participants were taken by the nurse after 8 hours of fasting for the analysis of biochemical parameters. The blood samples of the participants were analyzed at the beginning and at the end of the 8th week in the biochemistry laboratory of the Faculty of Medicine, Gazi University to determine serum high-sensitivity troponin T (hs) -TnT) (ng/mL) levels of the participants.
Analysis of serum fetuin-A (ng/mL)
时间窗: 8 weeks
The blood samples of the participants were taken by the nurse after 8 hours of fasting for the analysis of biochemical parameters. Fetuin-A (ng/mL) concentrations in blood samples were analyzed in a private laboratory. For the analysis of fetuin-A levels, blood samples taken into yellow-capped gel tubes were kept at room temperature for 30-45 minutes while the tubes were in an upright position, then centrifuged at 3,000 rpm for 15 min and the serum was frozen at -80°C until assayed.
Body mass index calculation
时间窗: 8 weeks
Body mass indexes were calculated by applying 'body weight/height2 (kg/m2)' equation.
Analysis of serum total cholesterol (mg/dL), low-density lipoprotein cholesterol (LDL-C) (mg/dL), high-density lipoprotein cholesterol (HDL-C) (mg/dL), triglyceride (mg/dL), fasting blood glucose (mg/dL), calcium (mg/dL) and phosphorus (mg/dL)
时间窗: 8 weeks
The blood samples of the participants were taken by the nurse after 8 hours of fasting for the analysis of biochemical parameters. The blood samples of the participants were analyzed at the beginning and at the end of the 8th week in the biochemistry laboratory of the Faculty of Medicine, Gazi University to determine total cholesterol (mg/dL), low-density lipoprotein cholesterol (LDL-C) (mg/dL), high-density lipoprotein cholesterol (HDL-C) (mg/dL), triglyceride (mg/dL), fasting blood glucose (mg/dL), calcium (mg/dL) and phosphorus (mg/dL) levels of the participants.
Analysis of serum fasting insulin (µIU/mL)
时间窗: 8 weeks
The blood samples of the participants were taken by the nurse after 8 hours of fasting for the analysis of biochemical parameters. The blood samples of the participants were analyzed at the beginning and at the end of the 8th week in the biochemistry laboratory of the Faculty of Medicine, Gazi University to determine serum fasting insulin (µIU/mL) levels of the participants.
Height and waist circumferences (cm) measurement
时间窗: 8 weeks
The height and waist circumferences (cm) of the participants were measured by using a non-elastic tape measure.
Body muscle mass analysis
时间窗: 8 weeks
The body muscle mass of the participants was analyzed at the beginning, every 15 days and at the end of the 8th week. The body muscle mass of the participants was analyzed through Tanita BC 601 bio-electric impedance device after 10-12 hours of hunger.
Homeostatic model assessment-insulin resistance (HOMA-IR)
时间窗: 8 weeks
Homeostatic model assessment-insulin resistance (HOMA-IR) values were calculated according to the formula: fasting insulin (mIU/mL) × fasting glucose (mg/dL)/405.
Body weight analysis
时间窗: 8 weeks
The body weight of the participants was analyzed at the beginning, every 15 days and at the end of the 8th week. The body weight of the participants was analyzed through Tanita BC 601 bio-electric impedance device after 10-12 hours of hunger.
Body fat percentage (%) and body water percentage (%) analysis
时间窗: 8 weeks
The body fat percentage and body water percentage of the participants were analyzed at the beginning, every 15 days and at the end of the 8th week. The body fat percentage and body water percentage of the participants were analyzed through Tanita BC 601 bio-electric impedance device after 10-12 hours of hunger.
Analysis of serum C-reactive protein (CRP) (mg/L)
时间窗: 8 weeks
The blood samples of the participants were taken by the nurse after 8 hours of fasting for the analysis of biochemical parameters. The blood samples of the participants were analyzed at the beginning and at the end of the 8th week in the biochemistry laboratory of the Faculty of Medicine, Gazi University to determine serum C-reactive protein (CRP) (mg/L) levels of the participants.
Nutritional assessment
时间窗: 8 weeks
A total of six-day food records (three-day food records with a 24-hour dietary recall method every 15 days and three consecutive-day food records at week 8.) were taken by the researcher for determining participants' daily dietary energy and nutrient intake. The energy and nutrient intake was calculated using the Nutrition Information System (BeBiS) program.
次要结局
- Personal Information Form(8 weeks)
研究者
Mehmet Arif Icer
Principal Investigator
Amasya University