Clinical trial NCT05661994: Omega-3 Supplementation on Serum Fetuin-A Levels
Official title: Effects of Omega-3 Fatty Acid Supplementation on Serum Fetuin-A Levels in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Fetuin-A
Omega-3 fatty acid
Coronary artery disease
Nutrient intake
Lead sponsor: Amasya University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2022-12-22
Enrollment: 34
Sex: MALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male volunteer patients aged 35-75 years
* Patients with newly diagnosed with coronary artery disease by conventional coronary angiography

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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)
timeFrame: 8 weeks
measure: Analysis of serum adiponectin (µg/mL)
timeFrame: 8 weeks
measure: Analysis of serum C-reactive protein (CRP) (mg/L)
timeFrame: 8 weeks
measure: Analysis of serum fasting insulin (µIU/mL)
timeFrame: 8 weeks
measure: Analysis of serum high-sensitivity troponin T (hs) -TnT) (ng/mL)
timeFrame: 8 weeks
measure: Analysis of serum fetuin-A (ng/mL)
timeFrame: 8 weeks
measure: Homeostatic model assessment-insulin resistance (HOMA-IR)
timeFrame: 8 weeks
measure: Nutritional assessment
timeFrame: 8 weeks
measure: Body weight analysis
timeFrame: 8 weeks
measure: Height and waist circumferences (cm) measurement
timeFrame: 8 weeks
measure: Body mass index calculation
timeFrame: 8 weeks
measure: Body fat percentage (%) and body water percentage (%) analysis
timeFrame: 8 weeks
measure: Body muscle mass analysis
timeFrame: 8 weeks
Secondary outcomes:
measure: Personal Information Form
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Training and Research Hospital
Study officials:
References: