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Trial record 82 of 363 for:    transthyretin

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

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ClinicalTrials.gov Identifier: NCT03924089
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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).


Condition or disease Intervention/treatment Phase
Malnutrition End Stage Renal Disease Dietary Supplement: Oral nutritional supplement with probiotics Dietary Supplement: Oral nutritional supplement without probiotics Other: Dietary recommendations Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, multicenter, parallel-group trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Open to the intake of ONS or diet, but double-blind to the intake of probiotics
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral nutritional supplement with probiotics

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 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.
Other Name: Physical activity recommendations.

Experimental: Oral nutritional supplement without probiotics

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
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.
Other Name: Physical activity recommendations.

Active Comparator: Individualized dietary recommendations
Individualized dietary recommendations. Physical activity recommendations.
Other: Dietary recommendations
Dietary recommendations
Other Name: Physical activity recommendations.




Primary Outcome Measures :
  1. Change in weight [ Time Frame: Baseline and 6 months ]
    Weight in kg

  2. Change in fat free body mass [ Time Frame: Baseline and 6 months ]
    Fat free body mass in kg assessed by bioelectrical impedance analysis

  3. Change in serum albumin concentration [ Time Frame: Baseline and 6 months ]
    Serum albumin in g/dl

  4. Change in serum prealbumin concentration [ Time Frame: Baseline and 6 months ]
    Serum prealbumin in mg/dl


Secondary Outcome Measures :
  1. Change in handgrip strength [ Time Frame: Baseline and 6 months ]
    Handgrip strength in kg, measured by the jamar hydraulic hand dynamometer.

  2. Change in the score of the "Barthel" test. [ Time Frame: Baseline and 6 months ]
    The Barthel is a 10-item ordinal scale that measures functional independence in the domains of personal care and mobility. Specifically, it measures self-care, sphincter management, transfers and locomotion. The score ranges between 0 and 100 points. Scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, 91-99 indicates "slight" dependency, and 100 indicates independency.

  3. Change in the score of the Hospital Anxiety and Depression Scale (HADS). [ Time Frame: Baseline and 6 months ]
    Symptoms of depression and anxiety assessed by the Hospital Anxiety and Depression Scale (HADS). This questionnaire comprises two sub-scales, each one range from 0 to 21 points; one assesses the symptoms of depression, and the other one the symptoms of anxiety. At each sub-scale, a score below 7 is considered normal range, between 8 and 10 means probable presence of depression or anxiety respectively, and more than 11 suggests the presence of depression or anxiety respectively.

  4. Changes in plasma levels of high sensitivity C reactive protein (hs-CRP) [ Time Frame: Baseline and 6 months ]
    Plasma levels of high sensitivity C reactive protein (hs-CRP) in mg/dl

  5. Changes in plasma levels of 8-iso-prostaglandina F2 α (8-iso-PGF2-α) [ Time Frame: Baseline and 6 months ]
    Plasma levels of 8-iso-prostaglandina F2 α (8-iso-PGF2-α) in pg/ml



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924089


Contacts
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Contact: Gabriel Olveira, MD, PhD 0034951290343 gabrielm.olveira.sspa@juntadeandalucia.es

Locations
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Spain
Hospital Universitario Rey Juan Carlos Recruiting
Móstoles, Madrid, Spain
Contact: María Blanca Martínez Barbeito         
Hospital San Cecilio Recruiting
Granada, Spain
Contact: María Isabel Fernández Soto         
Hospital Regional Universitario de Málaga Recruiting
Málaga, Spain, 29009
Contact: Gabriel Olveira         
Sponsors and Collaborators
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Investigators
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Principal Investigator: Gabriel Olveira, MD, PhD Instituto de Investigación biomédica de Málaga

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Responsible Party: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier: NCT03924089     History of Changes
Other Study ID Numbers: PI18/01041
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will be published when the trial will be finished.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Malnutrition
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Nutrition Disorders
Antioxidants
Nutrients
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Growth Substances