NCT00852020已完成不适用
Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in CHF and COPD Patients. A Randomised, Double-blind and Controlled Pilot Study.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- compliance to nutrition therapy
研究概览
简要总结
To test the compliance, tolerance, safety and to get preliminary insights into the efficacy of a new oral nutritional supplement (containing n-3 fatty acids, amino acids and antioxidants) designed to prevent or delay cachexia and anorexia in patients with chronic heart failure (CHF) or chronic obstructive pulmonary disease (COPD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of CHF or COPD
- •current body weight less than 6 months ago
- •BMI >=20 and <=30 kg/m2
- •CHF: LVEF >=45% measured within the past 6 months
- •symptom status equivalent to NYHA class II to IV
- •biochemical abnormalities for total cholesterol, serum uric acid, abnormal high CRP
- •on standard therapy of CHF including ACE inhibitors and beta blockers
- •COPD: symptom status equivalent to GOLD standard class II to IV
- •FEV1 < 80%
- •FEV1/FEV < 70%
排除标准
- •significant oedema in the time of screening and randomisation
- •concomitant inflammatory diseases
- •active infections including HIV and AIDS
- •liver failure
- •chronic renal failure (sCr>1.5mg/dL) or cardiac pacemaker
- •acute or chronic infections
- •insulin treated diabetes mellitus
- •patient with established diagnosis of cachexia
- •life expectancy of less than 6 months in the opinion of the investigator
- •medications that impair sex hormone synthesis, secretion or function
- •patients with psychiatric diseases
- •body weight loss > 5% during the last 6 months or > 10% during the last 10 months
- •suspected allergy to any component of the investigational product(s)
- •fish oil supplementation within 3 months prior to the study entry
- •taking vitamin supplements in doses greater than the Recommended Daily Allowances
研究组 & 干预措施
1
Experimental
oral nutritional supplement containing n-3-fatty acids, amino acids and antioxidants
干预措施: oral nutrition supplement, food for special medical purposes (Dietary Supplement)
2
Placebo Comparator
oral nutritional supplement (isocaloric, isonitrogenous)
干预措施: oral nutrition supplement, food for special medical purposes (Dietary Supplement)
结局指标
主要结局
compliance to nutrition therapy
时间窗: baseline, months 1, 2, 3, 4
次要结局
- Gastrointestinal syndrome score (GIS)(baseline, months 1, 2, 3, 4)
- body cell mass(baseline, months 1, 2, 3, 4)
- hand grip strength(baseline, months 1, 2, 3, 4)
- patient global assessment (PGA)(baseline, months 2, 4)
- anorexia questionnaire(baseline, months 1, 2, 3, 4)
- weight change(baseline, months 1, 2, 3, 4)
研究者
研究点 (4)
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