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NCT Number: NCT05661994

Omega-3 Supplementation on Serum Fetuin-A Levels

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.

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Key information

Conditions

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

Age range

35 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University Training and Research Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

    Time frame: 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.

  2. Analysis of serum adiponectin (µg/mL)

    Time frame: 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.

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

    Time frame: 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.

  4. Analysis of serum fasting insulin (µIU/mL)

    Time frame: 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.

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

    Time frame: 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.

  6. Analysis of serum fetuin-A (ng/mL)

    Time frame: 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.

  7. Homeostatic model assessment-insulin resistance (HOMA-IR)

    Time frame: 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.

  8. Nutritional assessment

    Time frame: 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.

  9. Body weight analysis

    Time frame: 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.

  10. Height and waist circumferences (cm) measurement

    Time frame: 8 weeks

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

  11. Body mass index calculation

    Time frame: 8 weeks

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

  12. Body fat percentage (%) and body water percentage (%) analysis

    Time frame: 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.

  13. Body muscle mass analysis

    Time frame: 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.

Secondary outcomes

  1. Personal Information Form

    Time frame: 8 weeks

    The data of the study were collected using a face-to-face interview technique through a questionnaire. Descriptive information about the individuals (age, gender, marital status, education level, physical activity, smoking, alcohol and drug use) and nutritional habits were questioned with the questionnaire form.

Sponsors and collaborators

Lead sponsor

Amasya University

Other

Collaborators

  • Gazi University

Registry information

Official study title

Effects of Omega-3 Fatty Acid Supplementation on Serum Fetuin-A Levels in Patients With Coronary Artery Disease

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 22, 2022
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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