Ignite Creation Date:
2024-05-06 @ 6:26 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05661994
Status:
COMPLETED
Last Update Posted:
2022-12-22
First Post:
2022-10-31
Brief Title:
Omega-3 Supplementation on Serum Fetuin-A Levels
Sponsor:
Amasya University
Organization:
Amasya University
Study Overview
Official Title:
Effects of Omega-3 Fatty Acid Supplementation on Serum Fetuin-A Levels in Patients With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n16 and Control Group n18 Low-fat diet principles were explained to both groups at baseline While 1560 mgday 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
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 n16 and Control Group n18 Low-fat diet principles were explained to both groups at baseline While 1560 mgday 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 andor vitaminmineral supplements or statin group drugs been BMI 185 and 40 kgm2 been fasting blood glucose 126 mgdL 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 66175679-5141101-E290378 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 n16 and Control Group n18 to evaluate the effects of omega-3 FA supplementation on biochemical parameters especially serum fetuin-A anthropometric measurements and nutritional status 1560 mgday 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
Patients with CAD were divided into the Omega-3 Group n16 and Control Group n18 to evaluate the effects of omega-3 FA supplementation on biochemical parameters especially serum fetuin-A anthropometric measurements and nutritional status 1560 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None