Ischemic CardiomyopathyICMPNCT07462858
Tuna Based Nuggets and Ischemic Cardiomyopathy
A study testing tuna based nuggets in people with Ischemic Cardiomyopathy and Obesity, Metabolically Benign, run by University of Lahore Hospital (ULH) at 1 site in Pakistan.
Trial summary
the study is to evaluate the effect of tuna-based nuggets on cardiomyopathy patients. participants were recruited from cardiology hospital and selenium dose in form of nuggets were given to patients that were enrolled in treatment group for three months. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Cardiomyopathy, Obesity, Metabolically Benign
- What is being tested?
- tuna based nuggets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2025to 25 Jan 2026
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed ICMP patients post-myocardial infarction
- Type 2 diabetic patients
- Age range between 35 to 70 years
- Overweight individuals (BMI > 25 kg/m²)
- Presence of dyslipidemia Exclusion Criteria
- Chronic renal failure
Show all 11Show fewer
- Hepatic failure
- Connective tissue disorders
- Respiratory failure
- Hypertrophic cardiomyopathy
- Heart failure with preserved ejection fraction (EF > 40%)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Efficacy Assessment of Tuna-based (Thunnus Albacares) Nuggets on Cardio-metabolic Risk Factors in Ischemic Cardiomyopathy Patients
the study is to evaluate the effect of tuna-based nuggets on cardiomyopathy patients. participants were recruited from cardiology hospital and selenium dose in form of nuggets were given to patients that were enrolled in treatment group for three months. the finding were improved biomarker level(IL-6) and lab investigations.
Read the detailed description
this study aims to assess the effect of a nutritional interventional with tuna based nugget with diet plan on BMI, dietary habits and anti-inflammatory level in blood. as tuna is taken as best source of selenium that is effective for cardiomyopathy patients. Eligible participants received dietary counselling with one slice of fish nugget daily foe 12 weeks. anthropometric measurements, biochemical and anti-inflammatory test was done before and after completion of study. Out of 120 participants, 60 were enrolled as treatment and other 60 as control group with no intervention.
- Being tested
- tuna based nuggets
- Medical subject headings
- Obesity, Metabolically Benign
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tuna based nuggetsDietary supplement
Also called non
tuna based nugget(5g) having recommended selenium amount and herbs without frying process.
| Study group | Role | What they receive |
|---|---|---|
| tuna fish nuggets | Experimental | tuna fish nugget having 5g weight each for 12 weeks on daily basis. one nugget per day constitute 55micro gram selenium Receives: Dietary Supplement: tuna based nuggets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin (IL-6)
anti inflammatory marker
Measured: 3months
C- Reactive Protein(CRP)
anti-inflammatory marker
Measured: 3months
Cardiac Kinase(CK)
Cardiac enzymes
Measured: 3months
Secondary outcomes (4)
BMI(Body Mass Index)
Anthropometric measurements
Measured: 3 months
Fasting Basal Sugar
levels below 100mg/dL in samples are considered normal
Measured: 3-months
Total Cholesterol
In blood sample normal value should be less than 200mg/dL. Total cholesterol: <200mg/dL
Measured: 3-months
Triglycerides
In triglycerides, blood test should be between 10-150mg/dL
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start15 Sep 2025
- Primary completion15 Jan 2026
- Study completion25 Jan 2026
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 Ischemic CardiomyopathyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- in this model screened participants are randomly assigned to two groups at a same time. one treatment group and one is placebo group. treatment group takes nutritional interventions for three month. at the end both groups were compared for analysis and conclusion was drawn.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore Hospital (ULH)
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Wajeeha Bashir Baig, University of Lahore Hospital (ULH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462858
- Sponsor's protocol ID
- 123456
- Acronym
- ICMP
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luo Y, He X, Hu L, Zhao J, Su K, Lei Y, Li Y. The Relationship Between Plasma Selenium, Antioxidant Status, Inflammatory Responses and Ischemic Cardiomyopathy: A Case-Control Study Based on Matched Propensity Scores. J Inflamm Res. 2022 Oct 10;15:5757-5765. doi: 10.2147/JIR.S383476. eCollection 2022.
PubMed 36238760
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Efficacy Assessment of Tuna-based (Thunnus Albacares) Nuggets on Cardio-metabolic Risk Factors in Ischemic Cardiomyopathy Patients
- ClinicalTrials.gov ID
- NCT07462858
- Acronym / sponsor ID
- ICMP / 123456
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Lahore Hospital (ULH)Research network
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 25 Jan 2026 (actual)
- First posted
- 10 Mar 2026 (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.
the study is to evaluate the effect of tuna-based nuggets on cardiomyopathy patients. participants were recruited from cardiology hospital and selenium dose in form of nuggets were given to patients that were enrolled in treatment group for three months. the finding were improved biomarker level(IL-6) and lab investigations.
Detailed description
this study aims to assess the effect of a nutritional interventional with tuna based nugget with diet plan on BMI, dietary habits and anti-inflammatory level in blood. as tuna is taken as best source of selenium that is effective for cardiomyopathy patients. Eligible participants received dietary counselling with one slice of fish nugget daily foe 12 weeks. anthropometric measurements, biochemical and anti-inflammatory test was done before and after completion of study. Out of 120 participants, 60 were enrolled as treatment and other 60 as control group with no intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- in this model screened participants are randomly assigned to two groups at a same time. one treatment group and one is placebo group. treatment group takes nutritional interventions for three month. at the end both groups were compared for analysis and conclusion was drawn.
| Arm | Type | Receives |
|---|---|---|
| tuna fish nuggets | Experimental | Dietary Supplement: tuna based nuggetstuna fish nugget having 5g weight each for 12 weeks on daily basis. one nugget per day constitute 55micro gram selenium |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosed ICMP patients post-myocardial infarction
- Type 2 diabetic patients
- Age range between 35 to 70 years
- Overweight individuals (BMI > 25 kg/m²)
- Presence of dyslipidemia Exclusion Criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| tuna based nuggetsAlso: nontuna based nugget(5g) having recommended selenium amount and herbs without frying process. | Dietary supplement | tuna fish nuggets |
Primary outcome
Interleukin (IL-6)
Time frame: 3months
anti inflammatory marker
C- Reactive Protein(CRP)
Time frame: 3months
anti-inflammatory marker
Cardiac Kinase(CK)
Time frame: 3months
Cardiac enzymes
4 secondary outcomes
BMI(Body Mass Index)
Time frame: 3 months
Fasting Basal Sugar
Time frame: 3-months
Total Cholesterol
Time frame: 3-months
Triglycerides
Time frame: 3-months
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 10 Mar 2026.
- Results publication: PubMed 36238760Luo Y, He X, Hu L, Zhao J, Su K, Lei Y, Li Y. The Relationship Between Plasma Selenium, Antioxidant Status, Inflammatory Responses and Ischemic Cardiomyopathy: A Case-Control Study Based on Matched Propensity Scores. J Inflamm Res. 2022 Oct 10;15:5757-5765. doi: 10.2147/JIR.S383476. eCollection 2022.
- 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 tuna based nuggets in people with Ischemic Cardiomyopathy and Obesity, Metabolically Benign, run by University of Lahore Hospital (ULH) at 1 site in Pakistan.
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 11 inclusion and 0 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 10 Mar 2026. 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 Pakistan. 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?
Interleukin (IL-6) (time frame: 3months). The study lists 3 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 NCT07462858, 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 10 Mar 2026.