Evaluation of the Clinical Effectiveness of Nutritional Supplements in Pulmonary Cachexia: A Quasi-Experimental Trial of n-3 PUFAs and Vitamin D
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Body Mass Index (BMI)
研究概览
简要总结
Pulmonary cachexia, observed in individuals with chronic obstructive pulmonary disease (COPD) is a multifactorial syndrome characterized by disruptions in energy metabolism, increased protein degradation, and an impaired capacity to preserve muscle mass. These metabolic disturbances not only exacerbate the underlying respiratory condition but also significantly contribute to elevated mortality rates among affected individuals.
Current therapeutic strategies for managing cachexia primarily emphasize pharmacological treatments, nutritional interventions, and multimodal approaches. Among the nutritional interventions, various supplements have shown potential in mitigating the catabolic processes associated with cachexia. Notably, supplementation with n-3 polyunsaturated fatty acids (n-3 PUFAs) and vitamin D has emerged as a promising intervention, likely due to their involvement in key pathological mechanisms underlying the disease.
While previous studies have investigated the combined effects of these supplements through oral nutritional supplementation, this study aims to evaluate and compare the clinical effectiveness of n-3 PUFAs and vitamin D as distinct therapeutic interventions for managing pulmonary cachexia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide both written and verbal consent.
- •Clinically diagnosed with chronic obstructive pulmonary disease (COPD).
- •Diagnosis of pulmonary cachexia according to Cachexia Consensus Conference criteria
排除标准
- •Patients experiencing acute exacerbations of COPD.
- •Patients with co-morbid chronic diseases that can also cause cachexia, including cancer, HIV/AIDS, heart failure, chronic renal failure, liver cirrhosis, and rheumatoid arthritis
- •Pregnant women and patients with abnormal liver and/or renal function tests.
- •Patients who have taken n-3 PUFAs, Vitamin D, or any intervention for cachexia in the past four weeks.
- •Patients on oral or parenteral corticosteroids for more than four weeks.
- •Patients with a history of allergies to fish-derived products, n-3 polyunsaturated fatty acids (PUFAs), or Vitamin D.
- •Patients with a metabolic disorder that can lead to changes in body composition.
研究组 & 干预措施
Vitamin D
干预措施: Vitamin D (Dietary Supplement)
Control
N-3 Polyunsaturated Fatty Acids (PUFA)
干预措施: N-3 Polyunsaturated Fatty Acids (PUFA) (Dietary Supplement)
结局指标
主要结局
Change in Body Mass Index (BMI)
时间窗: Baseline and Week 6
Change in BMI from baseline (pre-intervention), measured using a calibrated weight and height scale, and expressed in kg/m².
Fat-Free Mass Index (FFMI)
时间窗: Baseline and week 6
Change in FFMI from baseline (pre-intervention), measured using bioelectrical impedance analysis, and expressed in kg/m².
Fat Mass Index (FMI)
时间窗: Baseline and week 6
Change in FFM from baseline (pre-intervention), measured using bioelectrical impedance analysis, and expressed in kg/m².
Handgrip Strength (HGS)
时间窗: Baseline and week 6
Change from baseline HGS measured in kilograms using a calibrated dynamometer.
Mid-Arm Muscle Circumference (MAMC)
时间窗: Baseline and week 6
Change in MAMC from baseline (pre-intervention), calculated using the formula: MAMC = Mid-Arm Circumference (MAC) - (π × Triceps Skinfold (TSF)), expressed in centimeters (cm). The Mid-Arm Circumference (MAC) is measured using a flexible tape measure at the midpoint of the upper arm, and Triceps Skinfold (TSF) is measured using skinfold caliper.
Simplified Nutritional Appetite Questionnaire (SNAQ) - Anorexia
时间窗: Baseline and week 6
Change in SNAQ score from baseline (pre-intervention). SNAQ is a brief, four-item screening tool used to assess anorexia with a score of 14 or below indicates poor appetite.
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
时间窗: Baseline and week 6
Change in FACIT-F score from baseline (pre-intervention). FACIT-F is a 13-item scale used to assess the severity of fatigue in patients with chronic illnesses, with a scale range of 0 to 52. Higher scores indicate less fatigue (better functional status), while lower scores indicate more severe fatigue (worse functional status).
Edmonton Symptom Assessment System (ESAS) - Symptom Burden
时间窗: Baseline and week 6
Change in ESAS score from baseline (pre-intervention). ESAS is a multi-item scale used to assess symptom burden in patients. The scale ranges from 0 to 100, with higher scores indicating greater symptom severity and lower scores indicating less severe symptoms
次要结局
- Medication Adherence(Week 6)
- Adverse Effects(Eight weeks)
研究者
Safeer Khan
Principal Investigator
University of Lahore