This website is for US healthcare professionals

close-icon

Log In to Bolder Science

or

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

or
  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number
close-icon

Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

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

  • Clinicaltrials.gov identifier

    NCT03924089

  • Recruitment Status

    Recruiting

  • First Posted

    April 23, 2019

  • Last update posted

    May 1, 2019

Study Description

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:End Stage Renal Disease
    Malnutrition
  • Intervention/Treatment: Dietary Supplement: Oral nutritional supplement with probiotics
    Dietary Supplement: Oral nutritional supplement without probiotics
    Other: Dietary recommendations
  • Phase: N/A

Detailed Description

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: - The clinical response after the nutritional intervention: 1. Nutritional status: anthropometric measurements, handgrip strength measured by a jamar hand dynamometer, body composition assessed by bioelectrical impedance analysis (BIA), and a 5 days dietary record. 2. Functional status assessed by the "Barthel" test, the "Short Physical Performance Battery" and the "International Physical Activity Questionnaire". 3. Quality of life assessed by the "12-item short form health survey", and the presence of symptoms of depression and anxiety by the "Hospital Anxiety and Depression Scale". - The physiological response after the nutritional intervention: 1. Inflammatory markers. 2. Oxidative markers. 3. Gut microbiota. 4. Circulating miRNAs and the expression of its target genes on cells. Study design: - Randomized, multicenter, parallel-group trial with 3 groups, open to the intake of ONS or diet, but double-blind to the intake of probiotics. - Study centers: 1. Hospital Regional Universitario de Málaga (Spain). 2. Hospital San Cecilio. Granada (Spain). 3. Hospital Rey Juan Carlos. Móstoles, Madrid (Spain). - One-hundred and twenty patients will be included. Eligible subjects will be invited to participate, and written informed consent will be obtained before the inclusion. Participants will be randomly assigned to one of these three groups: 1. ONS with probiotics. Dietary and physical activity recommendations. 2. ONS without probiotics. Dietary and physical activity recommendations. 3. Dietary and physical activity recommendations. - The study duration is 6 months, and comprises 4 visits (screening, basal, 3 months and 6 months). Recruitment period: 12 months. - Inclusion criteria: 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. - A nutritional examination that included anthropometric measurements, handgrip strength measured by a jamar 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).

Study Design

  • Study Type: Interventional
  • 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)
  • 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 2019
  • Estimated Primary Completion Date: October 2020
  • Estimated Study Completion Date: October 2020

Arms and interventions

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

Outcome Measures

  • 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

Eligibility Criteria

  • 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) 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.

Contacts and Locations

Contacts

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

Locations

Spain, Madrid
Hospital Universitario Rey Juan Carlos
Móstoles

Spain
Hospital San Cecilio
Granada

Spain
Hospital Regional Universitario de Málaga
Málaga

Sponsors and Collaborators

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

Investigators

Principal Investigator: Gabriel Olveira, MD, PhD Instituto de Investigación biomédica de Málaga

More Information

  • 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.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Kidney Failure, Chronic Malnutrition