Walnuts for Cardiorenal Protection in Adults With Chronic Kidney Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorInstitut Investigacio Sanitaria Pere Virgili
About this trial
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.
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Daily Walnut Consumption
Other interventionParticipants 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Daily Walnut ConsumptionExperimental treatment 1 intervention
Group B: Control: MedDiet-based dietary counselingNo intervention 0 interventions
Trial outcomes
Primary outcomes
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.
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.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.
Time frame
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.
Time frame
CKD remission will be evaluated at the end of the 6-month follow-up period.Secondary outcomes
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.
Time frame
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 period2
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.
Time frame
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.
Time frame
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.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov