MalnutritionRENACARENCT03924089
Oral Nutritional Supplement on Nutritional and Functional Status, and Biomarkers in Malnourished Hemodialysis Patients.
A study testing Oral nutritional supplement with probiotics, Oral nutritional supplement without probiotics and Dietary recommendations in people with Malnutrition and End Stage Renal Disease, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, End Stage Renal Disease
- What is being tested?
- Oral nutritional supplement with probiotics, Oral nutritional supplement without probiotics and Dietary recommendations
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesSpain
- Study dates
- 15 Apr 2019to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 23Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital San Cecilio
Granada
Hospital Regional Universitario de Málaga
Málaga, 29009
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid
About this study
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.
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.
Read more
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).
Read the 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:
- 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.
- Functional status assessed by the "Barthel" test, the "Short Physical Performance Battery" and the "International Physical Activity Questionnaire".
- 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:
- Inflammatory markers.
- Oxidative markers.
- Gut microbiota.
- 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:
- Hospital Regional Universitario de Málaga (Spain).
- Hospital San Cecilio. Granada (Spain).
- 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:
- ONS with probiotics. Dietary and physical activity recommendations.
- ONS without probiotics. Dietary and physical activity recommendations.
- 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).
- Conditions
- Malnutrition, End Stage Renal Disease
- Being tested
- Oral nutritional supplement with probiotics, Oral nutritional supplement without probiotics, Dietary recommendations
- Medical subject headings
- Malnutrition, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutritional supplement with probioticsDietary supplement
Also called Physical activity recommendations.
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.
Oral nutritional supplement without probioticsDietary supplement
Also called Physical activity recommendations.
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.
Dietary recommendationsOther
Also called Physical activity recommendations.
Dietary recommendations
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Oral nutritional supplement without probiotics |
| Individualized dietary recommendations | Active comparator | Individualized dietary recommendations. Physical activity recommendations. Receives: Other: Dietary recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Weight in kg
Measured: Baseline and 6 months
Change in fat free body mass
Fat free body mass in kg assessed by bioelectrical impedance analysis
Measured: Baseline and 6 months
Change in serum albumin concentration
Serum albumin in g/dl
Measured: Baseline and 6 months
Change in serum prealbumin concentration
Serum prealbumin in mg/dl
Measured: Baseline and 6 months
Secondary outcomes (5)
Change in handgrip strength
Handgrip strength in kg, measured by the jamar hydraulic hand dynamometer.
Measured: Baseline and 6 months
Change in the score of the "Barthel" test.
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.
Measured: Baseline and 6 months
Change in the score of the Hospital Anxiety and Depression Scale (HADS).
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.
Measured: Baseline and 6 months
Changes in plasma levels of high sensitivity C reactive protein (hs-CRP)
Plasma levels of high sensitivity C reactive protein (hs-CRP) in mg/dl
Measured: Baseline and 6 months
Changes in plasma levels of 8-iso-prostaglandina F2 α (8-iso-PGF2-α)
Plasma levels of 8-iso-prostaglandina F2 α (8-iso-PGF2-α) in pg/ml
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start15 Apr 2019
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, multicenter, parallel-group trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Olveira, MD, PhD, Principal investigator, Instituto de Investigación biomédica de Málaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924089
- Sponsor's protocol ID
- PI18/01041
- Acronym
- RENACARE
- Status last verified
- Feb 2021
- First submitted
- 8 Apr 2019
- Last updated
- 23 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be published when the trial will be finished.
Publications
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.
PubMed 37870148Hevilla 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.
PubMed 36819685Nishioka 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.
PubMed 36472884
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03924089
- Acronym / sponsor ID
- RENACARE / PI18/01041
- Conditions
- Malnutrition, End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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:
- 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.
- Functional status assessed by the "Barthel" test, the "Short Physical Performance Battery" and the "International Physical Activity Questionnaire".
- 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:
- Inflammatory markers.
- Oxidative markers.
- Gut microbiota.
- 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:
- Hospital Regional Universitario de Málaga (Spain).
- Hospital San Cecilio. Granada (Spain).
- 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:
- ONS with probiotics. Dietary and physical activity recommendations.
- ONS without probiotics. Dietary and physical activity recommendations.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, multicenter, parallel-group trial.
| Arm | Type | Receives |
|---|---|---|
| Oral nutritional supplement with probiotics | Experimental | Dietary Supplement: Oral nutritional supplement with probioticsOral 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. |
| Oral nutritional supplement without probiotics | Experimental | Dietary Supplement: Oral nutritional supplement without probioticsOral 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. |
| Individualized dietary recommendations | Active comparator | Other: Dietary recommendationsIndividualized dietary recommendations. Physical activity recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (23 listed)
- Type 1 diabetes mellitus or type 2 diabetes mellitus with HbA1c>9%.
- Unstable dry weight.
- Limb amputation.
- Significant edema.
- Active malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral nutritional supplement with probioticsAlso: Physical activity recommendations.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. | Dietary supplement | Oral nutritional supplement with probiotics |
| Oral nutritional supplement without probioticsAlso: Physical activity recommendations.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. | Dietary supplement | Oral nutritional supplement without probiotics |
| Dietary recommendationsAlso: Physical activity recommendations.Dietary recommendations | Other | Individualized dietary recommendations |
Primary outcome
Change in weight
Time frame: Baseline and 6 months
Weight in kg
Change in fat free body mass
Time frame: Baseline and 6 months
Fat free body mass in kg assessed by bioelectrical impedance analysis
Change in serum albumin concentration
Time frame: Baseline and 6 months
Serum albumin in g/dl
Change in serum prealbumin concentration
Time frame: Baseline and 6 months
Serum prealbumin in mg/dl
5 secondary outcomes
Change in handgrip strength
Time frame: Baseline and 6 months
Change in the score of the "Barthel" test.
Time frame: Baseline and 6 months
Change in the score of the Hospital Anxiety and Depression Scale (HADS).
Time frame: Baseline and 6 months
Changes in plasma levels of high sensitivity C reactive protein (hs-CRP)
Time frame: Baseline and 6 months
Changes in plasma levels of 8-iso-prostaglandina F2 α (8-iso-PGF2-α)
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Derived from this study: PubMed 37870148Cooper 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.
- Derived from this study: PubMed 36819685Hevilla 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.
- Derived from this study: PubMed 36472884Nishioka 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.
- Individual participant dataSharing planned: No. The data will be published when the trial will be finished.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Olveira, MD, PhD principal investigator
Instituto de Investigación biomédica de Málaga
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral nutritional supplement with probiotics, Oral nutritional supplement without probiotics and Dietary recommendations in people with Malnutrition and End Stage Renal Disease, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: Baseline and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03924089, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.