NCT07462858

Brief 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. the finding were improved biomarker level(IL-6) and lab investigations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

February 25, 2026

Last Update Submit

March 5, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Interleukin (IL-6)

    anti inflammatory marker

    3months

  • C- Reactive Protein(CRP)

    anti-inflammatory marker

    3months

  • Cardiac Kinase(CK)

    Cardiac enzymes

    3months

Secondary Outcomes (4)

  • BMI(Body Mass Index)

    3 months

  • Fasting Basal Sugar

    3-months

  • Total Cholesterol

    3-months

  • Triglycerides

    3-months

Study Arms (1)

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

Dietary Supplement: tuna based nuggets

Interventions

tuna based nuggetsDIETARY_SUPPLEMENT

tuna based nugget(5g) having recommended selenium amount and herbs without frying process.

Also known as: non
tuna fish nuggets

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed ICMP patients post-myocardial infarction
  • Type 2 diabetic patients
  • Age range between 35 to 70 years
  • Overweight individuals (BMI \> 25 kg/m²)

You may not qualify if:

  • Chronic renal failure
  • Hepatic failure
  • Connective tissue disorders
  • Respiratory failure
  • Hypertrophic cardiomyopathy
  • Heart failure with preserved ejection fraction (EF \> 40%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

punjab institute of cardiology, Lahore

Lahore, Pakistan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity, Metabolically Benign

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
there was no masking because participants were counselled for that they were receiving in dietary intervention and researcher either as dietician had to guide participants.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 10, 2026

Study Start

September 15, 2025

Primary Completion

January 15, 2026

Study Completion

January 25, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations