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CKD - Chronic Kidney DiseaseNutReCardNCT07851454

Walnuts for Cardiorenal Protection in Adults With Chronic Kidney Disease

A study testing Daily Walnut Consumption in people with CKD - Chronic Kidney Disease and Renal Function, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To date, no rigorous randomized controlled trials have demonstrated a protective effect of daily moderate walnut consumption on kidney function or chronic kidney disease (CKD) progression in individuals with CKD. Read more about this study

Who is it for?
Ages 45 to 75 years
What is being tested?
Daily Walnut Consumption
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteSpain
Study dates
4 Aug 2026to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women with stable mild to moderate chronic kidney disease [CKD] (stage G3a-b (estimated glomerular filtration rate [eGFR] 30-<60mL/min/1.73 m²) and albuminuria stages A1-3 (UACR from < 30mg/g to ≥ 300 mg/g))
  • 45-75 years old at screening
  • Overweight/obesity (Body Mass Index [BMI] ≥25 and ≤40 kg/m²)
  • Meet at least one of the following conditions:
  • Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, or use of antihypertensive agents (ii) Triglycerides ≥150 mg/dL, LDL cholesterol ≥160 mg/dL, HDL cholesterol ≤40 mg/dL in men or ≤50 mg/dL in women, or use of lipid-modifying medication (iii) Prediabetes or type 2 diabetes according to the American Diabetes Association (ADA) Standards, or use of glucose-lowering medication.

Who cannot join

  • Inability to give written informed consent
  • CKD caused by polycystic kidney disease, chronic pyelonephritis, and renal dysplasia
  • CKD on renal replacement therapy (hemodialysis, peritoneal dialysis, and kidney transplant recipients)
  • Acute exacerbation of CKD, whether due to extrarenal causes (decompensated heart failure, infectious disease or sepsis, surgical intervention) or due to an outbreak of underlying glomerular or systemic renal pathology, with changes in treatment in the last 2 months.
  • Nut allergy
  • Alcoholism (>50 g/day) or drug abuse
Show all 9Show fewer
  • Treatment with immunosuppressant drugs or cytotoxic agents
  • Any other medical condition that interferes with the completion of the protocol (pregnancy/breastfeeding, history of inflammatory bowel disease, liver failure, cancer or active neoplasms, psychiatric problems)
  • Institutionalization of the participant.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrés Díaz López, PhD contact

+34 977759372

andres.diaz@urv.cat

Verónica Ruíz García, PhD contact

+34 677150430

vruiz.hj23.ics@gencat.cat

Spain1 site, 1 recruiting
  • Unit for Public Health and Nutritional Epidemiology, Faculty of Medicine and Health Sciences, Universitat Rovira i Virgili

    Reus, Tarragona, 43201

    Andrés Díaz López, PhD, +34 977759372, andres.diaz@urv.cat

    Verónica Ruíz García, PhD, +34 677150430, vruiz.hj23.ics@gencat.cat

    Recruiting

Other trials in Spain

About this study

Official title: Impact of Walnut Consumption on Renal Function and Classical and Emerging Biomarkers of Cardiovascular Risk in Adults With Chronic Kidney Disease: The NutReCard Study

To date, no rigorous randomized controlled trials have demonstrated a protective effect of daily moderate walnut consumption on kidney function or chronic kidney disease (CKD) progression in individuals with CKD.

Objective: To determine the effect of walnut supplementation (30 g/day of raw walnuts) within a Mediterranean diet (MedDiet) based dietary counseling program, compared with the same MedDiet counseling program without walnut supplementation, on kidney function, CKD progression and regression, and classical and emerging cardiovascular risk markers in individuals with CKD. Secondary objectives focus on assessing whether regular walnut consumption as a healthy snack has a positive impact on inflammation, oxidative stress, endothelial dysfunction, and intestinal dysbiosis, conditions intrinsically linked to CKD that play a pathophysiological role in promoting/exacerbating its progression and the development of comorbidities in this vulnerable group of subjects.

Read more

Methodology: A 6-month randomized controlled trial will be conducted in 150 men and women aged 45 to 75 years with stable mild to moderate CKD (stage G3a-b), overweight or obesity, and high cardiometabolic risk. The study will compare the effect of two interventions assessed at 3 and 6 months on the following outcomes:

  1. Primary outcomes: a) changes in kidney function assessed by the Estimated Glomerular Filtration Rate based on creatinine and cystatin C (eGFRcr-cys); b) CKD progression; and c) CKD remission
  2. Secondary outcomes: a) urinary albumin-to-creatinine ratio (UACR); b) mineral and bone metabolism parameters, c) anthropometry and body composition (Dual-Energy X-ray Absorptiometry, DXA); d) bone mineral density (DXA); e) diet quality; f) physical activity; g) medication use; h) psychological well-being; i) quality of life; j) classic cardiovascular risk markers; k) iron status and hepatic function; l) inflammation, endothelial function, and oxidation markers; m) gut microbiota
Being tested
Daily Walnut Consumption
Keywords
Nuts, Walnut, Mediterranean diet, Kidney function, Chronic kidney disease, Inflammation, Intestinal dysbiosis
Medical subject headings
Renal Insufficiency, Chronic, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daily Walnut ConsumptionOther

    Participants in the intervention group will consume 30 g/day of raw walnuts for 6 months in addition to receiving a Mediterranean diet (MedDiet)-based dietary counseling program.

Study groups in NCT07851454
Study groupRoleWhat they receive
Daily Walnut ConsumptionExperimentalParticipants in the intervention group will consume 30 g/day of raw walnuts in addition to receiving a Mediterranean diet (MedDiet)-based dietary counseling program. To ensure and facilitate adherence, participants will receive two educational leaflets: one providing practical guidance on following a MedDiet and another containing MedDiet-compatible recipes incorporating walnuts. They will also receive written guidance on optimizing phosphorus and potassium intake within a Mediterranean dietary pattern, including information on food sources, hidden additives, and cooking techniques that may reduce mineral content. Walnuts will be provided free of charge and distributed at baseline and at each follow-up visit.
Receives: Other: Daily Walnut Consumption
Control: MedDiet-based dietary counselingNo interventionParticipants in the control group will receive the same MedDiet-based dietary counseling without walnut supplementation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in renal function

    Renal function will be estimated using the estimated glomerular filtration rate (eGFR) calculated from serum creatinine (eGFRcr), cystatin-C (eGFRcys), or both (eGFRcr-cys), applying the CKD-Epidemiology Collaboration 2021 equation. Serum creatinine and cystatin C concentrations will be obtained from routine biochemical analyses performed as part of the participants' standard clinical care at the hospital.

    Measured: Participants will be followed for 6 months, with renal function assessments conducted at baseline, at the 3-month follow up period, and at the end of the 6-month follow-up period.

  2. Chronic Kidney Disease (CKD) Progression

    CKD progression will be assessed using eGFRcr-cys and defined as the first occurrence, during the 6-month intervention period, of any of the following criteria: (i) a decline in eGFRcr-cys of >2.5 mL/min/1.73 m² from baseline; (ii) a relative decline in eGFRcr-cys of >10% from baseline; or (iii) progression to a more advanced stage of kidney function impairment, defined as a transition from G3a to G3b or from G3b to G4 or higher.

    Measured: CKD progression will be evaluated at the end of the 6-month follow-up period.

  3. Chronic Kidney Disease (CKD) remission

    CKD remission will be assessed using eGFRcr-cys and defined as the first occurrence, during the 6-month intervention period, of any of the following criteria: (i) an increase in eGFRcr-cys of >2.5 mL/min/1.73 m² from baseline; or (ii) improvement to a less advanced stage of kidney function impairment, defined as a transition from G3b to G3a or from G3a to G2 or lower.

    Measured: CKD remission will be evaluated at the end of the 6-month follow-up period.

Secondary outcomes (24)
  1. Change from baseline in urinary albumin-to-creatinine ratio (UACR)

    The urinary albumin-to-creatinine ratio (UACR, mg/g) will be calculated from urinary albumin and creatinine concentrations measured in first-morning urine samples collected during routine clinical follow-up at the hospital by qualified healthcare personnel, following standard collection and laboratory procedures.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, at the 3-month follow-up period, and at the end of the 6-month follow-up period

  2. Change from baseline in mineral and bone metabolism markers

    Mineral and bone metabolism markers, including potassium, phosphorus, calcium, vitamin D, and parathyroid hormone, will be measured using standardized methods as part of routine fasting blood biochemical analyses.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, at the 3-month follow-up period, and at the end of the 6-month follow-up period.

  3. Change from baseline in body weight

    Body weight will be measured in kilograms (kg) by trained personnel using a calibrated scale, with participants lightly dressed and barefoot.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, at the 3-month follow-up period, and at the end of the 6-month follow-up period.

  4. Change from baseline in waist circumference

    Waist circumference will be measured in centimeters (cm) by trained personnel at the midpoint between the lowest rib and the iliac crest, using a non-stretchable anthropometric tape.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, at the 3-month follow-up period, and at the end of the 6-month follow-up period.

  5. Change from baseline in Body Mass Index (BMI)

    Body weight and height will be used to calculate body mass index (BMI), expressed in kg/m².

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, at the 3-month follow-up period, and at the end of the 6-month follow-up period.

  6. Change from baseline in body composition

    Body composition will be assessed using dual-energy X-ray absorptiometry (DXA), including measures of general adiposity, such as total fat mass in grams and total body fat percentage, and regional adiposity, including trunk, leg, android, and gynoid fat mass in grams.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, and at the end of the 6-month follow-up period.

  7. Change from baseline in bone mineral density

    Bone mineral density will be assessed using dual-energy X-ray absorptiometry (DXA).

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, and at the end of the 6-month follow-up period.

  8. Change from baseline in diet quality

    Diet will be assessed using a validated 143-item semiquantitative food frequency questionnaire and the 14-item Mediterranean Diet Adherence Screener (MEDAS). The Mediterranean Diet Adherence Screener score ranges from 0 to 14, with higher scores indicating greater adherence to the Mediterranean diet.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, at the 3-month follow-up period, and at the end of the 6-month follow-up period.

  9. Change from baseline in physical activity

    Physical activity will be assessed using the validated Registre Gironí del Cor (REGICOR) questionnaire, which estimates energy expenditure in total leisure-time physical activity and according to intensity, including light, moderate, and vigorous activity. Physical activity will be expressed in metabolic equivalents (METs), with higher values indicating greater levels of physical activity.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, and at the end of the 6-month follow-up period.

  10. Change from baseline in medication use affecting glomerular hemodynamics

    Medication use will be assessed by administering a general questionnaire by trained personnel, and from the patient's medical history.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, at the 3-month follow up period, and at the end of the 6-month follow-up period.

  11. Change from baseline in severity of depressive symptoms

    Severity of depressive symptoms will be evaluated using the self-administered Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a validated and widely used tool, composed of nine items scored from 0 to 3 (max. 27), which correspond to the DSM-IV criteria and allow depression to be classified as minimal, mild, moderate, moderately severe and severe. Higher scores indicate greater severity of depressive symptoms.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, and at the end of the 6-month follow-up period.

  12. Change from baseline in severity of anxiety symptoms

    Severity of anxiety symptoms will be evaluated using the self-administered Generalized Anxiety Disorder-7 (GAD-7) questionnaire, a brief seven-item scale in which each item is scored from 0 to 3, with a total score from 0 to 21. Higher scores indicate greater severity of anxiety symptoms.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, and at the end of the 6-month follow-up period.

  13. Change from baseline in quality of life

    Quality of life will be assessed using the Kidney Disease Quality of Life-36 (KDQOL-36) questionnaire, a validated instrument for individuals with mild-to-moderate chronic kidney disease that includes the 12-Item Short Form Health Survey (SF-12) and kidney disease-specific subscales: Symptoms and Problems, Effects of Kidney Disease, and Burden of Kidney Disease. Scores for each domain range from 0 to 100, with higher scores indicating better health-related quality of life and a lower perceived burden of disease.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, and at the end of the 6-month follow-up period.

  14. Change from baseline in fasting glucose

    Fasting blood glucose will be measured in mg/dL using standardized methods as part of routine fasting blood biochemical analyses.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, at the 3-month follow up period, and at the end of the 6-month follow-up period.

  15. Change from baseline in glycated hemoglobin

    Glycated Hemoglobin (%) will be measured using standardized methods as part of routine fasting blood biochemical analyses.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, at the 3-month follow-up period, and at the end of the 6-month follow-up period.

  16. Changes from baseline in lipid profile

    Total cholesterol, LDL-cholesterol, HDL-cholesterol, non-HDL-C, triglycerides and lipoprotein A will be measured in mg/dL, using standardized methods as part of routine fasting blood biochemical analyses.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, at the 3-month follow-up period, and at the end of the 6-month follow-up period.

  17. Change from baseline in blood pressure

    Systolic and diastolic blood pressure (mmHg) will be determined after 5 minutes of rest by trained personnel, in triplicate using a semi-automatic oscillometric blood pressure monitor. The participant will be seated and will use their non-dominant arm.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, at the 3-month follow-up period, and at the end of the 6-month follow-up period.

  18. Change from baseline in iron status markers

    Iron status markers (serum iron, ferritin, transferrin, and transferrin saturation), will be measured using standardized methods as part of routine fasting blood biochemical analyses.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, at the 3-month follow up period, and at the end of the 6-month follow-up period.

  19. Change from baseline in hepatic function markers

    Hepatic function markers (AST, ALT, and GGT) will be measured using standardized methods as part of routine fasting blood biochemical analyses.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, at the 3-month follow up period, and at the end of the 6-month follow-up period.

  20. Change from baseline in lipoprotein profile (particle composition and size)

    Lipoprotein profile, including VLDL, LDL, and HDL subfractions composition and size, will be analyzed in fasting blood samples stored at -80 °C in the Biobank using the Advanced Lipoprotein Profile Liposcale® test, based on proton nuclear magnetic resonance (H-NMR) spectroscopy.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, and at the end of the 6-month follow-up period.

  21. Change from baseline in oxidative markers

    Oxidative stress markers, including oxidized low-density lipoprotein (LDL-ox) and malondialdehyde (MDA), will be measured in fasting blood samples stored at -80 °C in the Biobank using commercially available enzyme-linked immunosorbent assays (ELISAs).

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, and at the end of the 6-month follow-up period.

  22. Change from baseline in inflammatory markers

    Inflammatory markers, including interleukin-1 beta (IL-1β), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), tumor necrosis factor-alpha (TNF-α), adiponectin, and leptin, will be measured in fasting blood samples stored at -80 °C in the Biobank using a multiplex immunoassay.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, and at the end of the 6-month follow-up period.

  23. Change from baseline in endothelial function markers

    Endothelial function markers (VCAM-1, ICAM-1, E-selectin, and P-selectin) will be assessed in fasting blood samples stored at -80 °C in the Biobank using a multiplex immunoassay.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, and at the end of the 6-month follow-up period.

  24. Change from baseline in gut microbiota composition

    Gut microbiota composition will be assessed by shotgun metagenomic sequencing following DNA extraction, with subsequent taxonomic characterization of microbial diversity and functional potential using established bioinformatics pipelines. Participants will receive instructions and a collection kit for stool sample collection. Samples will be submitted frozen, processed, aliquoted, and stored at -80 °C in the Biobank until analysis.

    Measured: Participants will be followed for 6 months. Measurements will be done at baseline, and at the end of the 6-month follow-up period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2026
  2. Study start4 Aug 2026
  3. Primary completionFeb 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

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
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07851454
Sponsor's protocol ID
PI25/01680
Acronym
NutReCard
Status last verified
Sep 2026
First submitted
27 Aug 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Daily Walnut Consumption in people with CKD - Chronic Kidney Disease and Renal Function, run by Institut Investigacio Sanitaria Pere Virgili at 1 site 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrés Díaz López, PhD (+34 977759372, andres.diaz@urv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in renal function (time frame: Participants will be followed for 6 months, with renal function assessments conducted at baseline, at the 3-month follow up period, and at the end of the 6-month follow-up period.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 1 Oct 2026.

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