Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: 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.
Brief Summary: 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).


Options:
A: Arm Label: Corn Starch; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Corn starch | Arm Label: Fiber; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Fiber | Intervention Type: DIETARY_SUPPLEMENT; Name: Fiber; Assigned to Arm(s): Fiber | Intervention Type: DIETARY_SUPPLEMENT; Name: Corn starch; Assigned to Arm(s): Corn Starch
B: Arm Label: probiotic; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Probiotic | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Probiotic; Assigned to Arm(s): probiotic | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): placebo
C: Arm Label: Oral nutritional supplement with probiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Oral nutritional supplement with probiotics | Arm Label: Oral nutritional supplement without probiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Oral nutritional supplement without probiotics | Arm Label: Individualized dietary recommendations; Type: ACTIVE_COMPARATOR; Interventions: Other: Dietary recommendations | Intervention Type: DIETARY_SUPPLEMENT; Name: Oral nutritional supplement with probiotics; Assigned to Arm(s): Oral nutritional supplement with probiotics | Intervention Type: DIETARY_SUPPLEMENT; Name: Oral nutritional supplement without probiotics; Assigned to Arm(s): Oral nutritional supplement without probiotics | Intervention Type: OTHER; Name: Dietary recommendations; Assigned to Arm(s): Individualized dietary recommendations
D: Arm Label: Probiotic; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Probiotic | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Probiotic; Assigned to Arm(s): Probiotic

Answer: C