Omega-3 Supplementation on Serum Fetuin-A Levels

NCT ID: NCT05661994

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-18

Study Completion Date

2022-04-08

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Omega-3 Group

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.

Group Type EXPERIMENTAL

Omega-3 fatty acid supplementation

Intervention Type 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.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Omega-3 fatty acid supplementation

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role collaborator

Amasya University

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Arif Icer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gazi University Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 40538988 (View on PubMed)

Other Identifiers

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66175679-514.11.01-E.290378

Identifier Type: -

Identifier Source: org_study_id