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

NCT03924089 | Completed

• 1 other identifier: PI18/01041
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

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).

Conditions

Malnutrition; End Stage Renal Disease

Outcome Measures

Primary Outcomes (4)

• Change in weight

  Weight in kg

  Baseline and 6 months

• Change in fat free body mass

  Fat free body mass in kg assessed by bioelectrical impedance analysis

  Baseline and 6 months

• Change in serum albumin concentration

  Serum albumin in g/dl

  Baseline and 6 months

• Change in serum prealbumin concentration

  Serum prealbumin in mg/dl

  Baseline and 6 months

Secondary Outcomes (5)

• 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

• Changes in plasma levels of 8-iso-prostaglandina F2 α (8-iso-PGF2-α)

  Baseline and 6 months

Study Arms (3)

Oral nutritional supplement with probiotics

EXPERIMENTAL

Oral nutritional supplement specifically developed for undernourished hemodialysis patients enriched with functional nutrients (extra virgin olive oil, omega 3 fatty acids, whey protein, antioxidants, carnitine), with probiotics. Physical activity recommendations.

Dietary Supplement: Oral nutritional supplement with probiotics

Oral nutritional supplement without probiotics

EXPERIMENTAL

Oral nutritional supplement specifically developed for undernourished hemodialysis patients enriched with functional nutrients (extra virgin olive oil, omega 3 fatty acids, whey protein, antioxidants, carnitine), without probiotics. Physical activity recommendations.

Dietary Supplement: Oral nutritional supplement without probiotics

Individualized dietary recommendations

ACTIVE COMPARATOR

Individualized dietary recommendations. Physical activity recommendations.

Other: Dietary recommendations

Interventions

Oral nutritional supplement with probiotics DIETARY_SUPPLEMENT

Oral nutritional supplement specifically developed for undernourished hemodialysis patients enriched with functional nutrients (extra virgin olive oil, omega 3 fatty acids, whey protein, antioxidants and carnitine), with probiotics.

Also known as: Physical activity recommendations.

Oral nutritional supplement with probiotics

Oral nutritional supplement without probiotics DIETARY_SUPPLEMENT

Oral nutritional supplement specifically developed for undernourished hemodialysis patients enriched with functional nutrients (extra virgin olive oil, omega 3 fatty acids, whey protein, antioxidants and carnitine), without probiotics.

Also known as: Physical activity recommendations.

Oral nutritional supplement without probiotics

Dietary recommendations OTHER

Dietary recommendations

Also known as: Physical activity recommendations.

Individualized dietary recommendations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Written informed consent obtained.

You may not qualify if:

• 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.
• 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.
• Pregnant women.
• No informed consent obtained.
• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead

Study Sites (3)

Hospital Universitario Rey Juan Carlos

Móstoles, Madrid, Spain

Location

Hospital San Cecilio

Granada, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, 29009, Spain

Location

Related Publications (3)

• Cooper TE, Khalid R, Chan S, Craig JC, Hawley CM, Howell M, Johnson DW, Jaure A, Teixeira-Pinto A, Wong G. Synbiotics, prebiotics and probiotics for people with chronic kidney disease. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD013631. doi: 10.1002/14651858.CD013631.pub2.

  PMID: 37870148 DERIVED

• Hevilla F, Padial M, Blanca M, Barril G, Jimenez-Salcedo T, Ramirez-Ortiz M, Nogueira A, Gentile A, Garcia-Escobar E, Romero-Zerbo SY, Olveira G. 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". Front Nutr. 2023 Feb 3;10:1107869. doi: 10.3389/fnut.2023.1107869. eCollection 2023.

  PMID: 36819685 DERIVED

• Nishioka N, Luo Y, Taniguchi T, Ohnishi T, Kimachi M, Ng RC, Watanabe N. Carnitine supplements for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013601. doi: 10.1002/14651858.CD013601.pub2.

  PMID: 36472884 DERIVED

MeSH Terms

Conditions

Malnutrition; Kidney Failure, Chronic

Interventions

Dietary Supplements; Probiotics

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Gabriel Olveira, MD, PhD

  Instituto de Investigación biomédica de Málaga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Open to the intake of ONS or diet, but double-blind to the intake of probiotics
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, multicenter, parallel-group trial.

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 23, 2019
• Study Start: April 15, 2019
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: June 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)