NCT02962089已完成不适用
Do Branched Chain Amino Acids Counteract Protein Energy Wasting Through Gut Microbiota Changes in Hemodialysis Patients ?
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 10
- 主要终点
- Gut microbiota function by 16-S high throughput sequencing
研究概览
简要总结
Oral supplementation with branched chain amino acids (BCAA) increases the levels of circulating BCAA, stimulates BCAA uptake in muscles, and decreases amino acid release from muscle, eventually promoting muscle anabolism. However, uptake of oral BCAA by muscle is not complete, pointing out that non-muscular tissues, as the splanchnic bed and gut microbiota, may play a role in BCAA metabolism.
This protocol aims at studying the impact of protein-energy wasting (PEW) and of refeeding with branched chain amino acids (BCAA), on gut barrier including gut microbiota, in chronic hemodialysis (HD) patients. The investigators speculate that:
- HD patients with PEW have altered composition and function of gut microbiota, increased permeability of epithelial gut barrier, increased systemic inflammation but decreased fecal immunoglobulin A (IgA), and a dysbalance of plasma appetite mediators in favor of anorexigenic mediators, compared to HD patients without PEW, non dialyzed patients with chronic kidney disease and well-nourished non obese subjects,
- BCAA supplementation of HD patients with PEW reverses these changes, thereby improving nutritional state, physical function, quality of life and resistance to infections.
详细描述
General description :
This protocol is multicenter (University Hospitals of Geneva (HUG), Lausanne University Hospital (CHUV), Hospital of Sion (HVS), dialysis center of the Champel clinic in Geneva and dialysis center of the Cécil clinic in Lausanne) and encompasses two parts, a cross-sectional and a longitudinal study:
- Cross-sectional study: It is performed to differentiate the respective impact of uremia and protein-energy wasting (PEW) on gut barrier and gut microbiota. It will compare gut barrier of hemodialysis (HD) patients with PEW, with gut barrier of age-matched HD well-nourished patients, non dialyzed patients with chronic kidney disease (CKD), and healthy non obese volunteers (10 in each group). This study part is essential for interpretation of the changes occurring in the longitudinal study.
- Longitudinal double blind randomized crossover study: HD patients with PEW (36 patients), receive, in a randomized double-blind order, either BCAA or an isocaloric isonitrogenous placebo for 4 months each, with a wash-out period of 1 month.
Randomization :
- Cross-sectional study: No randomization will be performed. HD patients without PEW, non dialyzed patients with CKD and healthy non obese volunteers will be included if matched for gender and age with the included HD patients with PEW. Age-matching will allow a discrepancy of +/- 5 years compared to the HD patient.
- Longitudinal study: Sequence assignment will be randomized separately in each center to ensure an equal percentage of each sequence in both centers. For this purpose, the investigators will generate 2 lists of randomization with the method of randomly permuted blocks with random block sizes of 2 and 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Maintenance hemodialysis for at least 3 months.
- •Fasting predialysis plasma albumin < 38 g/l in the absence of any known acute infection during the last 2 weeks or body weight loss > 5% of estimated dry body weight over 3 months
- •Dietary intakes (24h dietary recall) between 20-30 kcal/kg/d and < 1 g protein/kg/d on one occasion, during screening. These intakes will not include the intake of oral nutritional supplements, as intakes below 20 kcal/kg/d request artificial nutrition
- •Absence of any systematic antibiotic treatment for an acute infection in the month preceding the inclusion
排除标准
- •Known psychiatric or cognitive disorder, precluding protocol compliance.
- •Life expectancy below 1 year.
- •Inadequate dialysis (Kt/V<1.2 on 3 consecutive occasions, for HD patients only), if applicable.
- •Enteral or parenteral nutrition.
- •Drugs or oral nutritional supplements containing fibers since ≤ 1 month.
- •Known reasons for decreased plasma albumin levels as liver failure or exudative enteropathy.
- •Drugs influencing body composition, ≤ 1 month : systemic corticosteroids, anabolic drugs as insulin or testosterone, post-menopausal hormone therapy, injectable contraceptives.
- •Known endocrinological disorders potentially leading to hypo- or hypermetabolism, untreated or treated since ≤ 1 month : disorders of thyroid gland, adrenal glands...
- •Pregnancy and breast-feeding.
结局指标
主要结局
Gut microbiota function by 16-S high throughput sequencing
时间窗: Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9)
Gut microbiota composition by 16-S high throughput sequencing
时间窗: Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9)
次要结局
- Systemic inflammation by fasting level of plasma interleukin 10(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Appetite by fasting level of plasma neuropeptide Y(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Epithelial gut barrier function by fasting level of plasma glucagon-like peptide-2(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Appetite by fasting level of plasma endocannabinoids(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Physical activity level by 7-day pedometry(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Handgrip strength by dynamometer(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Quality of life score by Short Form Health Survey (SF-36)(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Appetite by fasting level of plasma cholecystokinin(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Appetite by fasting level of plasma leptin(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Appetite by fasting level of plasma glucagon-like peptide-1(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Calorie and protein intakes by 3-day food diary(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Resting energy expenditure (REE) by indirect calorimetry(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Epithelial gut barrier function by fasting level of plasma lipopolysaccharide(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Intestinal immunity by level of fecal IgA(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Systemic inflammation by fasting level of plama interleukin 6(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Systemic inflammation by fasting level of plama tumor necrosis factor alpha(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Appetite by fasting level of plasma peptide YY(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Body composition by dual-energy x-rax absorptiometry (DEXA)(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Appetite by fasting level of plasma ghrelin(Changes between baseline and end of each treatment (i.e.changes between Month 0 and Month 4 and between Month 5 and Month 9))
- Body composition by bioelectrical impedance analysis(Changes between baseline and end of each treatment (i.e.changes between Month 0,2, and Month 4 and between Month 5,7 and Month 9))
研究者
Genton Graf Laurence
Associate Physician at Clinical Nutrition Unit
University Hospital, Geneva
研究点 (10)
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