Comparing nutrient intake, functional capacity and quality of life in adults with COPD, given either an oral nutritional protein supplement with dietary counselling or receiving dietary counselling alone
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the effects of an oral nutritional supplement ONS taken with dietary counseling vs dietary counseling among COPD patients
研究概览
简要总结
Almost 90% of COPD deaths occur in low- and middle-income countries, where effective strategies for prevention and control are not always implemented or accessible. Several key aspects of managing nutritional complications in COPD must be addressed, from assessing nutritional needs to implementing dietary strategies. Regular assessment of weight, BMI, and dietary intake is crucial for identifying and addressing nutritional issues early. This study will explore and inform the development of appropriate nutrition intervention strategies to improve the nutritional status, functional capacity, and thus QoL of patients with COPD. The primary objective is to compare the effects of an oral nutritional supplement (ONS) taken with dietary counseling vs. dietary counseling alone on Protein consumption. The secondary objective is to to compare the effects of an oral nutritional supplement (ONS) taken with dietary counseling vs. dietary counseling alone on Energy Consumption, Total food intake, Serum Total Protein, Serum Albumin: Globulin (A/G) ratio, Quality of life, Change in BMI, Change in Body weight, Hand grip strength will be assessed using a dynamometer at baseline and the end of the study and Distance walked 6 mins (or 12 mins) at baseline and the end of the study. PI Max and PE Max will be measured to assess lung function and will be recorded using spirometry. The Energy, protein intake will be assessed at baseline, weeks 4, 8 and 12 using a food diary distributed by study personnel Blood drawn at baseline and at the end of the study will be used to assess serum protein and ratio of serum albumin to globulin. Quality of life and COPD severity will be assessed at baseline, weeks 4, 8 and 12 using SF-36questionnaire.Compliance will be calculated as the amount of ONS consumed in proportion to prescribed calories and Safety will be assessed at baseline and at each visit until the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •COPD stage 2, stage 3, stage 4
- •Medium to high degree of malnourishment according to MUST.
- •Subject must be able to eat and drink.
- •Subject must be free living.
- •Subject must be able to provide informed consent.
排除标准
- •Subjects with Liver, Heart or Kidney failure.
- •Subjects with Malignancy
- •Subjects with fever or pulmonary disease in addition to COPD.
- •Subjects with dysphagia
- •Subjects with poorly controlled diabetes.
- •Subjects with any disease state resulting in abnormal (high) A/G ratio.
- •Subjects receiving end of life care.
- •Subjects with known allergies to Milk and Collagen.
- •Subjects who are unable to provide informed consent.
- •Subjects with already taking health supplements.
结局指标
主要结局
To compare the effects of an oral nutritional supplement ONS taken with dietary counseling vs dietary counseling among COPD patients
时间窗: Day 0, Day 1, Day 28, Day 56. Day 84
1.Protein consumption
时间窗: Day 0, Day 1, Day 28, Day 56. Day 84
次要结局
- To compare the effects of an oral nutritional supplement (ONS) taken with dietary counseling vs. dietary counseling among COPD patients(1. Energy Consumption)
研究者
Dr J Mohanakrishnan
Apollo Speciality Hospitals Ayanambakkam Chennai
