Effects of Oral Citrulline Supplementation on Fat-free Mass in COPD Patients With Malnutrition
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Fat Free Mass Index
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is complicated by malnutrition in 20-70% of cases. In COPD, low fat-free mass is associated with a higher risk of morbidity and mortality. L-citrulline is a non-protein amino acid that has a direct effect on muscle protein synthesis. Oral supplementation with L-citrulline (10 g/day) in malnourished patients has shown to increase fat-free mass. The effects of L-citrulline supplementation in malnourished COPD patients are unknown.
The main objective of this prospective, single-centre, randomised, double-blind, placebo-controlled study will be to determine the impact of 45 days of nutritional supplementation with L-citrulline (10 g/day) on lean body mass (fat-free mass index (in kg.m-2) measured by bioelectrical impedance analysis) in malnourished patients (BMI < 20 kg/m2 if < 70 years old or < 22 kg/m2 if ≥ 70 years old) with COPD at stages 3-4 of the GOLD classification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 50 and over
- •COPD stage 3 or 4 according to GOLD criteria
- •BMI < 20 kg/m2 if < 70 years old or < 22 kg/m2 if ≥ 70 years old
- •Suspicion of sarcopenia marked by a score of 4 or more on the SARC-F questionnaire
- •Absence of severe COPD exacerbation for at least 3 months
排除标准
- •Main respiratory disease other than COPD
- •Daily long-term use of systemic corticosteroids (>6 months per year, whatever the dose)
- •Severe and end-stage renal insufficiency (creatinine clearance <30ml/min)
- •Patient with severe hypotension, uncontrolled hypertension (at investigator's discretion)
- •Contraindication to L-citrulline intake: VKA and/or cancer chemotherapy
- •Osmotic diarrhoea
- •Severe and/or uncontrolled progressive pathology likely to be life-threatening
- •Psychiatric pathology (schizophrenia, dementia, severe bipolar/psychotic disorders, severe depressive syndrome)
- •Pacemaker or other implanted electronic device
研究组 & 干预措施
Citrulline
The experimental product is 100% L-citrulline. Each pod will contain 10 grams of L-citrulline. Ten grams of L-citrulline provide 2.4 g of nitrogen.
干预措施: L-citrulline (Drug)
Standard care
The active comparator is a mixture of the six non-essential amino acids. In order for the active comparator to be iso-nitrogenated compared with the experimental product, it will provide 2.4 g of nitrogen per pod. The active comparator will combine 13.2 % alanine, 19.8 % aspartate, 11.2 % glycine, 17.1 % proline, 15.6 % serine and 23.1 % histidine, for a total of 13 g of amino acids per pod.
干预措施: L-citrulline (Drug)
结局指标
主要结局
Fat Free Mass Index
时间窗: baseline, 45+/-5 day and 1 year +/- 2 weeks
Fat Free Mass Index (in kg.m-2) measured by bioelectrical impedance analysis
次要结局
- Quality of life questionnaires(baseline, 45+/-5 day and 1 year +/- 2 weeks)
- 6-minute walk test(baseline, 45+/-5 day and 1 year +/- 2 weeks)
- Grip strength(baseline, 45+/-5 day and 1 year +/- 2 weeks)
- Maximum quadriceps strength(baseline, 45+/-5 day and 1 year +/- 2 weeks)
- Number of steps walked daily measured by actigraphy(baseline, 45+/-5 day and 1 year +/- 2 weeks)
- BODE index(baseline, 45+/-5 day and 1 year +/- 2 weeks)
- Visual Simplified Respiratory Questionnaire (VSRQ)(baseline, 45+/-5 day and 1 year +/- 2 weeks)
- DIsability RElated to COPD Tool (DIRECT)(baseline, 45+/-5 day and 1 year +/- 2 weeks)
- Flow-mediated dilation(baseline, 45+/-5 day and 1 year +/- 2 weeks)
- COPD Assessment Test (CAT)(baseline, 45+/-5 day and 1 year +/- 2 weeks)
- mMRC dyspnea scale(baseline, 45+/-5 day and 1 year +/- 2 weeks)