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.
Men and women.
Age between 40 and 75 years.
Normal weight or overweight nutritional status.
Regular attendance at healthcare follow-up visits.
Acute kidney injury within the three months preceding the intervention.
Inflammatory or infectious disease within the three months preceding the intervention.
Current smoking.
Use of oral anticoagulant therapy.
Parallel
maqui supplementation
Dietary supplementParticipants 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.
PLA
Dietary supplementParticipants 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
Inflamation
Interleukin-6 (IL-6), Relative expression of IL-6, assessed by Western blot and reported as relative protein expression.
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
Renal function
Urinary albumin-to-creatinine ratio (UACR), calculated from urinary albumin and urinary creatinine concentrations and reported in mg/g.
Gut microbiota alpha diversity
Gut microbiota alpha diversity assessed by 16S rRNA gene sequencing of stool samples and reported using Shannon index.
Gut microbiota beta diversity
Gut microbiota beta diversity assessed by 16S rRNA gene sequencing of stool samples and evaluated using a prespecified distance metric.
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 (%).
Plasma antioxidant capacity
Plasma antioxidant capacity will be assessed using a colorimetric assay.
Waist circumference
Waist circumference measured using a non-stretchable measuring tape and reported in centimeters (cm).
Body fat percentage
Body fat percentage assessed by bioelectrical impedance analysis using the InBody 270 and reported as percentage (%)
Dietary Inflammatory Index
Dietary Inflammatory Index score calculated from dietary intake assessed using food records and reported as DII score.
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