Development and Efficacy Assessment of Tuna-based (Thunnus Albacares) Nuggets on Cardio-metabolic Risk Factors in Ischemic Cardiomyopathy Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Interleukin (IL-6)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Chronic renal failure
- •Hepatic failure
- •Connective tissue disorders
- •Respiratory failure
- •Hypertrophic cardiomyopathy
- •Heart failure with preserved ejection fraction (EF > 40%)
研究组 & 干预措施
tuna fish nuggets
tuna fish nugget having 5g weight each for 12 weeks on daily basis. one nugget per day constitute 55micro gram selenium
干预措施: tuna based nuggets (Dietary Supplement)
结局指标
主要结局
Interleukin (IL-6)
时间窗: 3months
anti inflammatory marker
C- Reactive Protein(CRP)
时间窗: 3months
anti-inflammatory marker
Cardiac Kinase(CK)
时间窗: 3months
Cardiac enzymes
次要结局
- BMI(Body Mass Index)(3 months)
- Fasting Basal Sugar(3-months)
- Total Cholesterol(3-months)
- Triglycerides(3-months)
研究者
Wajeeha Bashir Baig
PhD
University of Lahore Hospital (ULH)