An interventional study of maqui supplementation and PLA in Chronic Kidney Disease (Stage 3-4), sponsored by Universidad Mayor. Not yet recruiting at 1 site in Chile. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Universidad Mayor · Not applicable, Interventional, and Prevention
Chronic kidney disease (CKD) is a highly prevalent condition in Chile and worldwide and is associated with a substantial burden of morbidity, particularly cardiovascular morbidity. In the early stages of CKD, treatment aims to preserve kidney function and slow the progression of associated complications. Several conditions have been reported in association with CKD, including impaired antioxidant capacity, inflammation, and alterations in the gut microbiota (GM), which contribute, among other complications, to the loss of kidney function and cardiovascular damage. In the search for therapeutic approaches to modulate CKD-related complications, there is growing interest in complementary non-pharmacological interventions, including nutritional strategies within the "Food as Medicine" concept. In this context, maqui remains largely unexplored in CKD. Maqui contains phenolic compounds with bioactive properties and strong antioxidant activity, which have also been associated with anticancer, antimicrobial, and anti-inflammatory effects, as well as inhibition of enzymes involved in metabolic syndrome, making this fruit of particular interest for human health. To date, no studies have evaluated the therapeutic potential of maqui in relation to oxidative stress, inflammation, gut microbiota, and CKD progression, or whether these biomarkers and the response to maqui supplementation differ according to biological sex.
To evaluate the effects of maqui supplementation in men and women on the modulation of gut microbiota, inflammatory parameters, and oxidative stress in patients with stage 3 and 4 chronic kidney disease.
A longitudinal, randomized, double-blind clinical trial will be conducted in patients with CKD recruited from healthcare centers in the Metropolitan Region of Santiago, Chile. Participants will receive either a dietary supplement containing dried maqui extract in powder form, equivalent to 200 mg of Delphinol, or placebo for three months. At baseline and after three months of intervention, gut microbiota composition, uremic toxins, inflammatory and oxidative stress markers (plasma antioxidant capacity, urinary polyphenols, IL-6, high-sensitivity C-reactive protein [hs-CRP], NGAL, and uremic toxins), parameters of CKD progression, and anthropometric and dietary parameters will be assessed.
This is a three-month, randomized, double-blind, placebo-controlled pilot clinical trial designed to evaluate the effects of maqui supplementation in adults with stage 3-4 chronic kidney disease (CKD). The study focuses on biological pathways involved in CKD progression, particularly systemic inflammation, oxidative stress, gut microbiota alterations, and the generation of gut-derived uremic toxins. An exploratory component of the study will examine whether baseline characteristics and responses to the intervention differ according to biological sex.
Participants will be randomly assigned to receive either a powdered maqui supplement, providing an amount equivalent to 200 mg of Delphinol, or a maltodextrin placebo once daily for three months. Randomization will be balanced by sex and age and conducted independently from the research team. Study products will be identified using alphanumeric codes to maintain blinding of participants and the clinical and research teams throughout the intervention.
Clinical and biological assessments will be performed at baseline and after three months of supplementation. Blood and urine samples will be collected to characterize kidney function, systemic inflammation, oxidative status, and other biochemical parameters related to CKD progression. Stool samples will be collected at the same time points to evaluate gut microbiota composition and gut-derived uremic toxins. Gut microbiota will be characterized through sequencing of the V4 region of the 16S rRNA gene.
The study will also assess anthropometric and body composition parameters, blood pressure, and dietary intake. Dietary intake will be evaluated using three-day food records, which will also be used to estimate the Dietary Inflammatory Index. Participants will receive monthly follow-up by a nutritionist during the intervention to assess adherence and identify relevant changes in dietary intake or other factors that could influence the response to supplementation.
The study is intended to provide preliminary clinical and biological evidence regarding the potential effects of maqui supplementation in CKD and to generate data for the design of a larger clinical trial. Given the pilot nature of the study, analyses according to biological sex will be considered exploratory.
Exclusion Criteria:
placebo = maltodextrin
Dietary Supplement: PLA
maqui
Dietary Supplement: maqui supplementation
Participants will receive either a powdered maqui supplement (equivalent to 200 mg of Delphinol) or placebo (maltodextrin), administered orally once daily, dissolved in water or incorporated into breakfast.
Participants will receive either a powdered maqui supplement (equivalent to 200 mg of Delphinol) or placebo (maltodextrin), administered orally once daily, dissolved in water or incorporated into breakfast.
inflamation
High-sensitivity C-reactive protein (hs-CRP) , Serum concentration of hs-CRP, measured by ELISA and reported in mg/L
Time frame: basal and final (3 months)
Inflamation
Interleukin-6 (IL-6), Relative expression of IL-6, assessed by Western blot and reported as relative protein expression.
Time frame: Baseline and 3 months
Renal function
Estimated glomerular filtration rate (eGFR), calculated using the CKD-EPI equation based on serum creatinine and reported in mL/min/1.73 m²
Time frame: basal and final (3 months)
Renal function
Urinary albumin-to-creatinine ratio (UACR), calculated from urinary albumin and urinary creatinine concentrations and reported in mg/g.
Time frame: baseline and 3 months
Gut microbiota alpha diversity
Gut microbiota alpha diversity assessed by 16S rRNA gene sequencing of stool samples and reported using Shannon index.
Time frame: basal and final (3 months)
Gut microbiota beta diversity
Gut microbiota beta diversity assessed by 16S rRNA gene sequencing of stool samples and evaluated using a prespecified distance metric.
Time frame: beseline and 3 months
Relative abundance of gut microbial taxa
Relative abundance of gut microbial taxa will be assessed in stool samples by sequencing the V4 region of the 16S rRNA gene and reported as relative abundance (%).
Time frame: baseline and 3 months
Plasma antioxidant capacity
Plasma antioxidant capacity will be assessed using a colorimetric assay.
Time frame: basal and final (3 months)
Protein carbonylation
Plasma protein carbonylation assessed using the 2,4-dinitrophenylhydrazine (DNPH) method and reported as carbonyl group concentration relative to total protein
Time frame: baseline and 3 month
Plasma indoxyl sulfate (IS) concentration
Plasma concentration of indoxyl sulfate, measured by reverse-phase high-performance liquid chromatography with fluorescence detection and reported in mg/L
Time frame: baseline and 3 months
Plasma p-cresyl sulfate (p-CS) concentration
Plasma concentration of p-cresyl sulfate, measured by reverse-phase high-performance liquid chromatography with fluorescence detection and reported in mg/L.
Time frame: baseline and 3 months
Plasma indole-3-acetic acid (IAA) concentration
Plasma concentration of IAA, measured by reverse-phase high-performance liquid chromatography with fluorescence detection and reported in µg/L.
Time frame: baseline and 3 monts
Waist circumference
Waist circumference measured using a non-stretchable measuring tape and reported in centimeters (cm).
Time frame: basal and final (3 months)
Body fat percentage
Body fat percentage assessed by bioelectrical impedance analysis using the InBody 270 and reported as percentage (%)
Time frame: baseline and 3 months
Dietary Inflammatory Index
Dietary Inflammatory Index score calculated from dietary intake assessed using food records and reported as DII score.
Time frame: baseline and 3 monts
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