Effects of Maqui Supplementation on Gut Microbiota, Inflammation, and Oxidative Stress in Patients With Chronic Kidney Disease

NCT07776925 | Not Yet Recruiting DMC

• 1 other identifier: 0671UM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease (Stage 3-4)

Keywords

berries; gut microbiota; inflamation; oxidative stress; chronic kidney disease

Outcome Measures

Primary Outcomes (4)

• inflamation

  High-sensitivity C-reactive protein (hs-CRP) , Serum concentration of hs-CRP, measured by ELISA and reported in mg/L

  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.

  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

  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.

  baseline and 3 months

Secondary Outcomes (8)

• Gut microbiota alpha diversity

  basal and final (3 months)

• Gut microbiota beta diversity

  beseline and 3 months

• Relative abundance of gut microbial taxa

  baseline and 3 months

• Plasma antioxidant capacity

  basal and final (3 months)

• Protein carbonylation

  baseline and 3 month

Other Outcomes (3)

• Waist circumference

  basal and final (3 months)

• Body fat percentage

  baseline and 3 months

• Dietary Inflammatory Index

  baseline and 3 monts

Study Arms (2)

control group

PLACEBO COMPARATOR

placebo = maltodextrin

Dietary Supplement: PLA

Intervention group

EXPERIMENTAL

maqui

Dietary Supplement: maqui supplementation

Interventions

maqui supplementation DIETARY_SUPPLEMENT

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.

Intervention group

PLA DIETARY_SUPPLEMENT

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.

control group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women.
• Age between 40 and 75 years.
• Normal weight or overweight nutritional status.
• Regular attendance at healthcare follow-up visits.
• CKD stage 3-4 (eGFR 59-15)

You may not qualify if:

• 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.
• Pregnancy.
• Current use of dietary supplements containing maqui.
• Cancer.
• Current antibiotic treatment or antibiotic use within the two weeks preceding the intervention.

Sponsors & Collaborators

• Universidad Mayor: lead

Study Sites (1)

Santiago

Santiago, Santiago Metropolitan, 7770093, Chile

Location

Related Publications (2)

• Tiscornia C, Tapia V, Aguila D, Lorca-Ponce E, Aicardi V, Vasquez F. Maqui and Chronic Kidney Disease: A Narrative Review on the Potential Nephroprotective Role of Anthocyanins. Nutrients. 2025 Mar 18;17(6):1058. doi: 10.3390/nu17061058.

  PMID: 40292440 BACKGROUND

• Alvarenga L, Salarolli R, Cardozo LFMF, Santos RS, de Brito JS, Kemp JA, Reis D, de Paiva BR, Stenvinkel P, Lindholm B, Fouque D, Mafra D. Impact of curcumin supplementation on expression of inflammatory transcription factors in hemodialysis patients: A pilot randomized, double-blind, controlled study. Clin Nutr. 2020 Dec;39(12):3594-3600. doi: 10.1016/j.clnu.2020.03.007. Epub 2020 Mar 13.

  PMID: 32204978 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Francisca FP Peña, PI

CONTACT

+569 96997318; francisca.pena@umayor.cl

Marcell ML Leonario, CoI

CONTACT

+569 37681326; marcell.leonario@umayor.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 20, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: August 20, 2026

Record last verified: 2026-08

Locations

CL (1)