Coronary Artery DiseaseNCT05661994
Omega-3 Supplementation on Serum Fetuin-A Levels
A study testing Omega-3 fatty acid supplementation in people with Coronary Artery Disease, run by Amasya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years, men only
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Omega-3 fatty acid supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Dec 2020to 8 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male volunteer patients aged 35-75 years
- Patients with newly diagnosed with coronary artery disease by conventional coronary angiography
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Training and Research Hospital
Ankara
About this study
Official title: Effects of Omega-3 Fatty Acid Supplementation on Serum Fetuin-A Levels in Patients With Coronary Artery Disease
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Omega-3 fatty acid supplementation
- Keywords
- Fetuin-A, Omega-3 fatty acid, Coronary artery disease, Nutrient intake
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acid supplementationDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Body mass index calculation
Body mass indexes were calculated by applying 'body weight/height2 (kg/m2)' equation.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (1)
Personal Information Form
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start18 Dec 2020
- Primary completion11 Oct 2021
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Mehmet Arif Icer, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661994
- Sponsor's protocol ID
- 66175679-514.11.01-E.290378
- Status last verified
- Dec 2022
- First submitted
- 31 Oct 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40538988
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Omega-3 Fatty Acid Supplementation on Serum Fetuin-A Levels in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05661994
- Acronym / sponsor ID
- 66175679-514.11.01-E.290378
- Conditions
- Coronary Artery Disease
- Keywords
- Fetuin-A, Omega-3 fatty acid, Coronary artery disease, Nutrient intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 11 Oct 2021 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Group | Experimental | Dietary Supplement: Omega-3 fatty acid supplementationWhile 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. |
| 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. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male volunteer patients aged 35-75 years
- Patients with newly diagnosed with coronary artery disease by conventional coronary angiography
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acid supplementationPatients 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. | Dietary supplement | Omega-3 Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Body mass index calculation
Time frame: 8 weeks
Body mass indexes were calculated by applying 'body weight/height2 (kg/m2)' equation.
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.
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.
1 secondary outcome
Personal Information Form
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Derived from this study: PubMed 40538988Icer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 fatty acid supplementation in people with Coronary Artery Disease, run by Amasya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 8 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05661994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.