Effect of an Oral Nutritional Supplement on Nutritional and Functional Status, Biological Markers (Inflammation and Oxidative Stress, Intestinal Microbiota, Circulating microRNA and Its Target Genes) in Malnourished Hemodialysis Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Change in weight
研究概览
简要总结
Malnutrition in hemodialysis patients is frequent and it is associated with a reduction in muscular mass, strength, functional capacity and quality of life, with an increment in inflammatory and oxidative markers, and with a dysregulation of circulating miRNAs and its target genes.
Animal and human studies have reported that some dietary components (macronutrients, micronutrients and other bioactive substances) might restore these altered features.
Thus, we hypothesized that the intake of an oral nutritional supplement (ONS) specifically developed for malnourished hemodialysis patients enriched with functional nutrients (extra virgin olive oil, omega 3 fatty acids, whey protein, antioxidants, carnitine, and with or without probiotics) vs. individualized diet recommendations might:
- Improve nutritional status (visceral proteins, muscular mass), functional capacity and quality of life.
- Reduce inflammatory and oxidative markers, and modulate the circulating levels of some miRNAs and the expression of its target genes on cells. miRNAs may be useful biomarkers to check the response to a nutritional intervention in malnourished hemodialysis patients.
The present study is a randomized, multicenter, parallel-group trial with 3 groups, open to the intake of ONS or individualized diet recommendations, but double-blind to the intake of probiotics. Inclusion criteria comprised adult subjects (>18 y/o) undergoing hemodialysis more than 6 months previous at inclusion and at least one of these caloric malnutrition criteria: a) involuntary weight loss >5% in 3 months or >10% in 6 months; b) serum albumin < 3.5 g/dl or prealbumin <28 mg/dl; c) body mass index (BMI) < 23 kg/m2; d) muscular mass loss >5% in 3 months or >10% in 6 months.
The study duration is 6 months, and comprises 4 visits (screening, basal, 3 months and 6 months). A nutritional examination that included anthropometric measurements, handgrip strength measured by a hand dynamometer, body composition assessed by bioelectrical impedance analysis (BIA) and a 5 days dietary record; quality of life evaluation by the "12-item short form health survey"; the presence of symptoms of depression and anxiety (Hospital Anxiety and Depression Scale); assessment of functional status by the "Barthel" test, the "Short Physical Performance Battery" and the "International Physical Activity Questionnaire"; and blood and stool samples will be obtained for each participant in each study visit (except screening visit).
详细描述
Hypothesis:
The intake of an oral nutritional supplement (ONS) specifically developed for malnourished hemodialysis patients enriched with functional nutrients (extra virgin olive oil, omega 3 fatty acids, whey protein, antioxidants, carnitine, and with or without probiotics) vs. individualized diet recommendations might:
- Improve nutritional status (visceral proteins, muscular mass), functional capacity and quality of life.
- Reduce inflammatory and oxidative markers, and modulate the circulating levels of some miRNAs and the expression of its target genes on cells. miRNAs may be useful biomarkers to check the response to a nutritional intervention in undernourished hemodialysis patients.
Aims:
To evaluate:
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)
盲法说明
Open to the intake of ONS or diet, but double-blind to the intake of probiotics
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
- •Adult subjects (>18 y/o) undergoing hemodialysis more than 6 months previous at inclusion.
- •At least one of these caloric malnutrition criteria: a) involuntary weight loss >5% in 3 months or >10% in 6 months; b) serum albumin < 3.5 g/dl or prealbumin <28 mg/dl; c) body mass index (BMI) < 23 kg/m2; d) muscular mass loss >5% in 3 months or >10% in 6 months.
- •Standard hemodialysis therapy (3 days/week, 240 min, high permeability dialyzer, blood flow >250 ml/min and dialysate flow 500 ml/min) or on-line hemodialysis therapy that was not modified in the last 3 months previous to the inclusion.
- •Written informed consent obtained.
排除标准
- •Type 1 diabetes mellitus or type 2 diabetes mellitus with HbA1c>9%.
- •Unstable dry weight.
- •Limb amputation.
- •Significant edema.
- •Active malignancy.
- •Hospital admissions in the last 3 months.
- •Acute gastrointestinal disease in the 2 weeks before the inclusion.
- •Gastrectomy, gastroparesis or abnormal gastric emptying.
- •Acute heart failure grade IV.
- •Severe hepatic insufficiency (men gamma glutamyl transferase -GGT- >150 U/l, women >120 U/l).
- •Alcohol or other drugs abuse.
- •Participants enrolled in other research study at inclusion.
- •Pregnant women.
- •No informed consent obtained.
- •Patients who received any oral nutritional supplement (specific for hemodialysis patients or not) in the 4 weeks before the inclusion.
- •Patients receiving enteral tube feeding.
- •Galactosemia, fructosemia, or requirement of a no fiber diet.
- •Allergy or hypersensitivity to any ingredient of the oral nutritional supplement.
- •Ongoing treatment with glucocorticoids.
- •Patients who received any oral fatty acids omega-3 supplement in the 4 weeks before the inclusion.
- •Patients who received intradialytic parenteral nutrition in the 3 months before the inclusion.
- •Patients who received any probiotics or prebiotics (not as part of the diet) in the 3 months before the inclusion.
- •Anemia (Hemoglobin < 10 g/dl) or Epoetin resistance.
结局指标
主要结局
Change in weight
时间窗: Baseline and 6 months
Weight in kg
Change in serum prealbumin concentration
时间窗: Baseline and 6 months
Serum prealbumin in mg/dl
Change in serum albumin concentration
时间窗: Baseline and 6 months
Serum albumin in g/dl
Change in fat free body mass
时间窗: Baseline and 6 months
Fat free body mass in kg assessed by bioelectrical impedance analysis
次要结局
- Changes in plasma levels of 8-iso-prostaglandina F2 α (8-iso-PGF2-α)(Baseline and 6 months)
- Change in handgrip strength(Baseline and 6 months)
- Change in the score of the "Barthel" test.(Baseline and 6 months)
- Change in the score of the Hospital Anxiety and Depression Scale (HADS).(Baseline and 6 months)
- Changes in plasma levels of high sensitivity C reactive protein (hs-CRP)(Baseline and 6 months)