Omega-3 Supplementation on Serum Fetuin-A Levels

NCT05661994 | Completed

• 1 other identifier: 66175679-514.11.01-E.290378
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Fetuin-A; Omega-3 fatty acid; Coronary artery disease; Nutrient intake

Outcome Measures

Primary Outcomes (13)

• 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)

  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.

  8 weeks

• Analysis of serum adiponectin (µg/mL)

  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.

  8 weeks

• Analysis of serum C-reactive protein (CRP) (mg/L)

  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.

  8 weeks

• Analysis of serum fasting insulin (µIU/mL)

  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.

  8 weeks

• Analysis of serum high-sensitivity troponin T (hs) -TnT) (ng/mL)

  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.

  8 weeks

• Analysis of serum fetuin-A (ng/mL)

  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.

  8 weeks

• Homeostatic model assessment-insulin resistance (HOMA-IR)

  Homeostatic model assessment-insulin resistance (HOMA-IR) values were calculated according to the formula: fasting insulin (mIU/mL) × fasting glucose (mg/dL)/405.

  8 weeks

• Nutritional assessment

  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.

  8 weeks

• Body weight analysis

  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.

  8 weeks

• Height and waist circumferences (cm) measurement

  The height and waist circumferences (cm) of the participants were measured by using a non-elastic tape measure.

  8 weeks

• Body mass index calculation

  Body mass indexes were calculated by applying 'body weight/height2 (kg/m2)' equation.

  8 weeks

• Body fat percentage (%) and body water percentage (%) analysis

  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.

  8 weeks

• Body muscle mass analysis

  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.

  8 weeks

Secondary Outcomes (1)

• Personal Information Form

  8 weeks

Study Arms (2)

Omega-3 Group

EXPERIMENTAL

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.

Dietary Supplement: Omega-3 fatty acid supplementation

Control Group

NO INTERVENTION

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.

Interventions

Omega-3 fatty acid supplementation DIETARY_SUPPLEMENT

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.

Omega-3 Group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amasya University: lead
• Gazi University: collaborator

Study Sites (1)

Gazi University Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• Icer MA, Yildiran H, Sahinarslan A, Topal S. Effects of Omega-3 Fatty Acid Supplementation on Serum Fetuin-A Levels in Patients With Coronary Artery Disease. Food Sci Nutr. 2025 Jun 18;13(6):e70460. doi: 10.1002/fsn3.70460. eCollection 2025 Jun.

  PMID: 40538988 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: December 22, 2022
• Study Start: December 18, 2020
• Primary Completion: October 11, 2021
• Study Completion: April 8, 2022
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)