Chronic Kidney Disease (Stage 3-4)maquibiotaNCT07776925
Effects of Maqui Supplementation on Gut Microbiota, Inflammation, and Oxidative Stress in Patients With Chronic Kidney Disease
A study testing maqui supplementation and PLA in people with Chronic Kidney Disease (Stage 3-4), run by Universidad Mayor at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Chronic Kidney Disease (Stage 3-4)
- What is being tested?
- maqui supplementation and PLA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 10 Sep 2026to 15 Mar 2027
- 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.
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site
Santiago
Santiago, Santiago Metropolitan, 7770093
Francisca Peña-Dardaillon, 996997318, francisca.pena@umayor.cl
About this study
Official title: Effects of Maqui Supplementation on Gut Microbiota, Inflammation, and Oxidative Stress in Patients With Chronic Kidney Disease: A Gender-Based Approach
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease (Stage 3-4)
- Being tested
- maqui supplementation, PLA
- Keywords
- berries, gut microbiota, inflamation, oxidative stress, chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maqui supplementationDietary 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.
PLADietary 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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | placebo = maltodextrin Receives: Dietary Supplement: PLA |
| Intervention group | Experimental | maqui Receives: Dietary Supplement: maqui supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflamation
High-sensitivity C-reactive protein (hs-CRP) , Serum concentration of hs-CRP, measured by ELISA and reported in mg/L
Measured: 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.
Measured: 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
Measured: 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.
Measured: baseline and 3 months
Secondary outcomes (8)
Gut microbiota alpha diversity
Gut microbiota alpha diversity assessed by 16S rRNA gene sequencing of stool samples and reported using Shannon index.
Measured: 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.
Measured: 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 (%).
Measured: baseline and 3 months
Plasma antioxidant capacity
Plasma antioxidant capacity will be assessed using a colorimetric assay.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: baseline and 3 monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start10 Sep 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease (Stage 3-4)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Mayor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisca Peña, Universidad Mayor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776925
- Sponsor's protocol ID
- 0671UM
- Acronym
- maquibiota
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40292440Alvarenga 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.
PubMed 32204978
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Maqui Supplementation on Gut Microbiota, Inflammation, and Oxidative Stress in Patients With Chronic Kidney Disease: A Gender-Based Approach
- ClinicalTrials.gov ID
- NCT07776925
- Acronym / sponsor ID
- maquibiota / 0671UM
- Conditions
- Chronic Kidney Disease (Stage 3-4)
- Keywords
- berries, gut microbiota, inflamation, oxidative stress, chronic kidney disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad MayorUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Dietary Supplement: PLAplacebo = maltodextrin |
| Intervention group | Experimental | Dietary Supplement: maqui supplementationmaqui |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maqui supplementationParticipants 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. | Dietary supplement | Intervention group |
| PLAParticipants 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. | Dietary supplement | control group |
Primary outcome
inflamation
Time frame: basal and final (3 months)
High-sensitivity C-reactive protein (hs-CRP) , Serum concentration of hs-CRP, measured by ELISA and reported in mg/L
Inflamation
Time frame: Baseline and 3 months
Interleukin-6 (IL-6), Relative expression of IL-6, assessed by Western blot and reported as relative protein expression.
Renal function
Time frame: basal and final (3 months)
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
Time frame: baseline and 3 months
Urinary albumin-to-creatinine ratio (UACR), calculated from urinary albumin and urinary creatinine concentrations and reported in mg/g.
8 secondary outcomes
Gut microbiota alpha diversity
Time frame: basal and final (3 months)
Gut microbiota beta diversity
Time frame: beseline and 3 months
Relative abundance of gut microbial taxa
Time frame: baseline and 3 months
Plasma antioxidant capacity
Time frame: basal and final (3 months)
Protein carbonylation
Time frame: baseline and 3 month
Plasma indoxyl sulfate (IS) concentration
Time frame: baseline and 3 months
Plasma p-cresyl sulfate (p-CS) concentration
Time frame: baseline and 3 months
Plasma indole-3-acetic acid (IAA) concentration
Time frame: baseline and 3 monts
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 40292440Tiscornia 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.
- Background: PubMed 32204978Alvarenga 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maqui supplementation and PLA in people with Chronic Kidney Disease (Stage 3-4), run by Universidad Mayor at 1 site in Chile.
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 8 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: opening soon, as of the sponsor's last update on 20 Aug 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 Chile. 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. Some participants in this study may receive a placebo. 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 Francisca FP Peña, PI (+569 96997318, francisca.pena@umayor.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflamation (time frame: basal and final (3 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07776925, which also lists 2 linked publications.
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 20 Aug 2026.