NCT03924089: RENACARE

Oral Nutritional Supplement on Nutritional and Functional Status, and Biomarkers in Malnourished Hemodialysis Patients.

Completed NA Last updated 23 June 2021

What this trial tests

NA trial testing Oral nutritional supplement with probiotics in Malnutrition in 54 participants. Completed in 15 June 2021.

Timeline

15 April 2019

Primary endpoint
15 June 2021

15 June 2021

Quick facts

Lead sponsor	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	54
Start date	15 April 2019
Primary completion	15 June 2021
Estimated completion	15 June 2021
Sites	3 locations across Spain

Drugs / interventions tested

• Oral nutritional supplement with probiotics
• Oral nutritional supplement without probiotics
• Dietary recommendations

Conditions studied

• Malnutrition — all drugs for Malnutrition →
• End Stage Renal Disease — all drugs for End Stage Renal Disease →

Sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud — full company profile →

Who can join

18 and older, any sex, with Malnutrition or End Stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Synbiotics, prebiotics and probiotics for people with chronic kidney disease.
   Cooper TE, Khalid R, Chan S, Craig JC, et al · · 2023 · cited 35× · PMID 37870148 · DOI 10.1002/14651858.cd013631.pub2
2. Dietary advice with or without oral nutritional supplements for disease-related malnutrition in adults.
   Baldwin C, de van der Schueren MA, Kruizenga HM, Weekes CE. · · 2021 · cited 24× · PMID 34931696 · DOI 10.1002/14651858.cd002008.pub5
3. Effect on nutritional status and biomarkers of inflammation and oxidation of an oral nutritional supplement (with or without probiotics) in malnourished hemodialysis patients. A multicenter randomized clinical trial "Renacare Trial".
   Hevilla F, Padial M, Blanca M, Barril G, et al · · 2023 · cited 13× · PMID 36819685 · DOI 10.3389/fnut.2023.1107869
4. Let-7i-5p Regulation of Cell Morphology and Migration Through Distinct Signaling Pathways in Normal and Pathogenic Urethral Fibroblasts.
   Zhang K, Yang R, Chen J, Qi E, et al · · 2020 · cited 11× · PMID 32478052 · DOI 10.3389/fbioe.2020.00428
5. Psychobiotic Protection of Nutritional Supplements and Probiotics in Patients Undergoing Hemodialysis: A Randomized Trial.
   Climent E, Hevilla F, Padial M, Barril-Cuadrado G, et al · · 2025 · cited 5× · PMID 40004979 · DOI 10.3390/nu17040652
6. Modulation of miR-29a and miR-29b Expression and Their Target Genes Related to Inflammation and Renal Fibrosis by an Oral Nutritional Supplement with Probiotics in Malnourished Hemodialysis Patients.
   Sasso CV, Lhamyani S, Hevilla F, Padial M, et al · · 2024 · cited 5× · PMID 38256206 · DOI 10.3390/ijms25021132
7. Modulation of miR-29a and miR-29b Expression by an Oral Nutritional Supplement Similar to the Mediterranean Diet Pattern with Probiotics in Malnourished Hemodialysis Patients
   Sasso CV, Lhamyani S, Hevilla F, Padial M, et al · · 2023 · DOI 10.20944/preprints202312.1566.v1