Ischemic Cardiomyopathy, Obesity, Metabolically Benign
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTtuna based nuggets
tuna based nugget(5g) having recommended selenium amount and herbs without frying process.
Sponsors
University of Lahore Hospital (ULH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * Hepatic failure * Connective tissue disorders * Respiratory failure * Hypertrophic cardiomyopathy * Heart failure with preserved ejection fraction (EF \> 40%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin (IL-6) | 3months | anti inflammatory marker |
| C- Reactive Protein(CRP) | 3months | anti-inflammatory marker |
| Cardiac Kinase(CK) | 3months | Cardiac enzymes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI(Body Mass Index) | 3 months | Anthropometric measurements |
| Fasting Basal Sugar | 3-months | levels below 100mg/dL in samples are considered normal |
| Total Cholesterol | 3-months | In blood sample normal value should be less than 200mg/dL. Total cholesterol: \<200mg/dL |
| Triglycerides | 3-months | In triglycerides, blood test should be between 10-150mg/dL |
Countries
Pakistan
Outcome results
None listed