Chronic Kidney DiseasesNCT06394531
Effects of Jaboticaba (Plinia Cauliflora) Supplementation in Chronic Kidney Disease Patients
A study testing Jaboticaba Peel Extract in people with Chronic Kidney Diseases, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
The increase prevalence of chronic kidney disease (CKD) over the years represent a significant public health problem. The role of inflammation and oxidative stress in the pathophysiology of CKD, as well as progression and comorbidities, is already well consolidated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Jaboticaba Peel Extract
- 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 siteBrazil
- Study dates
- 1 Jul 2026to 1 Jul 2028
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years
- Clinical diagnosis of Chronic Kidney Disease
- Conservative treatment group: CKD stages 3 and 5 receiving nutritional treatment for at least 6 months
- Hemodialysis group: Hemodialysis patients for more than 6 months
Who cannot join
- Patients pregnant
- Smokers
- Using antibiotics in the last 3 months
- Autoimmune diseases
- Clinical diagnosis of infectious diseases
- Clinical diagnosis of Cancer
- Clinical diagnosis of AIDS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Jaboticaba (Plinia Cauliflora) as a Strategy to Modulate Inflammation, Oxidative Stress, and Gut Dysbiosis in Patients With Chronic Kidney Disease
The increase prevalence of chronic kidney disease (CKD) over the years represent a significant public health problem. The role of inflammation and oxidative stress in the pathophysiology of CKD, as well as progression and comorbidities, is already well consolidated. The gut microbiota composition imbalance may also be a risk factor contributing to the increased conditions mentioned above, and to uremic toxins release and endotoxemia. The literature has indicated the use of bioactive compounds as a nonpharmacological treatment strategies for the management of non-communicable diseases (NCDs), such as CKD and its complications. In this context, jaboticaba (Plinia Cauliflora) emerges as a potential therapeutic approach as it is a source of phenolic compounds, such as anthocyanins, flavonols, ellagitannins, and phenolic acids. Such phenolic compounds may have beneficial effects in patients with CKD, such as anti-inflammatory, antioxidant, modulation of the intestinal microbiota, hypotensive and hypoglycemic effects. These combined effects can help manage risk factors and CKD itself, and associated complications. Therefore, this research project aims to add scientific knowledge, providing a non-pharmacological therapeutic approach to be implemented in clinical practice and in the care of patients with CKD, with the aim of modulating inflammation, oxidative stress, microbiota composition, and improving the quality of life of these patients. Therefore, this study aims to evaluate the effects of jaboticaba (Plinia Cauliflora) supplementation on complications associated with CKD.
Read the detailed description
This is a chronic study, which consists of a longitudinal, randomized, double-blind, crossover clinical study, with a washout period and placebo-controlled trial. Thirty patients with CKD undergoing hemodialysis will be selected (according to sample calculation, considering p=0.05 and test power of 80%). Randomization will be computerized in a 1:1 ratio, with a block size of 15 (Jaboticaba and Control groups), to receive jaboticaba peel extract or placebo. Eligible patients of both genders, previously evaluated and authorized by the medical and nutritionist team, will be invited to participate in the research in person and verbally, during nutritional consultations at the Prodoctor Hemodialysis Clinic. The intervention consists of supplementing 4 capsules/day, providing 3.3g of jabuticaba peel extract daily, containing 600mg of phenolic compounds, or the same amount of placebo, corn starch, for one month. After the end of this first intervention, blood and fecal samples will be collected again. Followed by a 2-month washout period. After 2 months, blood and fecal samples will be collected again from these patients. The crossover will then begin, the second moment of supplementation in which the patients who received the jaboticaba peel extract in the first moment start to receive the placebo, and the patients who received the placebo initially began to receive jabuticaba peel extract supplementation for one month. At the end of the second supplementation period, blood and fecal samples will be collected.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Jaboticaba Peel Extract, Placebo
- Keywords
- chronic kidney diseases, jaboticaba, inflammation, oxidative stress, microbitoa
- Medical subject headings
- Renal Insufficiency, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaboticaba Peel ExtractDietary supplement
Jaboticaba peel extract. Patients will ingest 4 capsules/day of jaboticaba (Plinia Cauliflora) peel extract, providing 3.3g of jabuticaba peel extract daily, containing 600mg of phenolic compounds, for one month.
PlaceboOther
Placebo. Patients will ingest 4 capsules/day of placebo (corn starch), providing 3.3g of placebo, for one month.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Jaboticaba peel extract. Patients will ingest 4 capsules/day of jaboticaba (Plinia Cauliflora) peel extract, providing 3.3g of jabuticaba peel extract daily, containing 600mg of phenolic compounds, for one month. Receives: Dietary Supplement: Jaboticaba Peel Extract |
| Placebo | Placebo comparator | Placebo. Patients will ingest 4 capsules/day of placebo (corn starch), providing 3.3g of placebo, for one month. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Antioxidant and anti-inflammatory biomarker
Get blood samples to evaluate the supplementation effects in antioxidant and anti-inflammatory biomarker- nuclear receptor factor 2 (Nrf2)
Measured: 4 weeks
Inflammatory biomarker
Get blood samples to evaluate the supplementation effects in inflammatory biomarker- factor nuclear kappa B (NFkB)
Measured: 4 weeks
Microbiota Composition
Get fecal samples to evaluate the supplementation effects in microbiota composition.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denise Mafra, Phd, Principal investigator, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394531
- Sponsor's protocol ID
- DeniseMafra20
- Status last verified
- May 2026
- First submitted
- 27 Apr 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lima MDC, do Nascimento HMA, da Silva JYP, de Brito Alves JL, de Souza EL. Evidence for the Beneficial Effects of Brazilian Native Fruits and Their By-Products on Human Intestinal Microbiota and Repercussions on Non-Communicable Chronic Diseases-A Review. Foods. 2023 Sep 19;12(18):3491. doi: 10.3390/foods12183491.
PubMed 37761200
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jaboticaba (Plinia Cauliflora) as a Strategy to Modulate Inflammation, Oxidative Stress, and Gut Dysbiosis in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06394531
- Acronym / sponsor ID
- DeniseMafra20
- Conditions
- Chronic Kidney Diseases
- Keywords
- chronic kidney diseases, jaboticaba, inflammation, oxidative stress, microbitoa
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 1 May 2024 (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.
The increase prevalence of chronic kidney disease (CKD) over the years represent a significant public health problem. The role of inflammation and oxidative stress in the pathophysiology of CKD, as well as progression and comorbidities, is already well consolidated. The gut microbiota composition imbalance may also be a risk factor contributing to the increased conditions mentioned above, and to uremic toxins release and endotoxemia. The literature has indicated the use of bioactive compounds as a nonpharmacological treatment strategies for the management of non-communicable diseases (NCDs), such as CKD and its complications. In this context, jaboticaba (Plinia Cauliflora) emerges as a potential therapeutic approach as it is a source of phenolic compounds, such as anthocyanins, flavonols, ellagitannins, and phenolic acids. Such phenolic compounds may have beneficial effects in patients with CKD, such as anti-inflammatory, antioxidant, modulation of the intestinal microbiota, hypotensive and hypoglycemic effects. These combined effects can help manage risk factors and CKD itself, and associated complications. Therefore, this research project aims to add scientific knowledge, providing a non-pharmacological therapeutic approach to be implemented in clinical practice and in the care of patients with CKD, with the aim of modulating inflammation, oxidative stress, microbiota composition, and improving the quality of life of these patients. Therefore, this study aims to evaluate the effects of jaboticaba (Plinia Cauliflora) supplementation on complications associated with CKD.
Detailed description
This is a chronic study, which consists of a longitudinal, randomized, double-blind, crossover clinical study, with a washout period and placebo-controlled trial. Thirty patients with CKD undergoing hemodialysis will be selected (according to sample calculation, considering p=0.05 and test power of 80%). Randomization will be computerized in a 1:1 ratio, with a block size of 15 (Jaboticaba and Control groups), to receive jaboticaba peel extract or placebo. Eligible patients of both genders, previously evaluated and authorized by the medical and nutritionist team, will be invited to participate in the research in person and verbally, during nutritional consultations at the Prodoctor Hemodialysis Clinic. The intervention consists of supplementing 4 capsules/day, providing 3.3g of jabuticaba peel extract daily, containing 600mg of phenolic compounds, or the same amount of placebo, corn starch, for one month. After the end of this first intervention, blood and fecal samples will be collected again. Followed by a 2-month washout period. After 2 months, blood and fecal samples will be collected again from these patients. The crossover will then begin, the second moment of supplementation in which the patients who received the jaboticaba peel extract in the first moment start to receive the placebo, and the patients who received the placebo initially began to receive jabuticaba peel extract supplementation for one month. At the end of the second supplementation period, blood and fecal samples will be collected.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: Jaboticaba Peel ExtractJaboticaba peel extract. Patients will ingest 4 capsules/day of jaboticaba (Plinia Cauliflora) peel extract, providing 3.3g of jabuticaba peel extract daily, containing 600mg of phenolic compounds, for one month. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo. Patients will ingest 4 capsules/day of placebo (corn starch), providing 3.3g of placebo, for one month. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 to 75 years
- Clinical diagnosis of Chronic Kidney Disease
- Conservative treatment group: CKD stages 3 and 5 receiving nutritional treatment for at least 6 months
- Hemodialysis group: Hemodialysis patients for more than 6 months
Key exclusion criteria (7 listed)
- Patients pregnant
- Smokers
- Using antibiotics in the last 3 months
- Autoimmune diseases
- Clinical diagnosis of infectious diseases
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 |
|---|---|---|
| Jaboticaba Peel ExtractJaboticaba peel extract. Patients will ingest 4 capsules/day of jaboticaba (Plinia Cauliflora) peel extract, providing 3.3g of jabuticaba peel extract daily, containing 600mg of phenolic compounds, for one month. | Dietary supplement | Intervention |
| PlaceboPlacebo. Patients will ingest 4 capsules/day of placebo (corn starch), providing 3.3g of placebo, for one month. | Other | Placebo |
Primary outcome
Primary Outcome Measure
Time frame: 4 weeks
Antioxidant and anti-inflammatory biomarker Get blood samples to evaluate the supplementation effects in antioxidant and anti-inflammatory biomarker- nuclear receptor factor 2 (Nrf2)
Inflammatory biomarker
Time frame: 4 weeks
Get blood samples to evaluate the supplementation effects in inflammatory biomarker- factor nuclear kappa B (NFkB)
Microbiota Composition
Time frame: 4 weeks
Get fecal samples to evaluate the supplementation effects in microbiota composition.
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 15 May 2026.
- Background: PubMed 37761200Lima MDC, do Nascimento HMA, da Silva JYP, de Brito Alves JL, de Souza EL. Evidence for the Beneficial Effects of Brazilian Native Fruits and Their By-Products on Human Intestinal Microbiota and Repercussions on Non-Communicable Chronic Diseases-A Review. Foods. 2023 Sep 19;12(18):3491. doi: 10.3390/foods12183491.
- Individual participant dataSharing planned: No
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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.
Denise Mafra, Phd principal investigator
Universidade Federal Fluminense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jaboticaba Peel Extract in people with Chronic Kidney Diseases, run by Universidade Federal Fluminense at 1 site in Brazil.
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 4 inclusion and 7 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 15 May 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 Brazil. 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 Denise Mafra, Phd (+55 21 985683003, dmafra30@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 4 weeks). The study lists 3 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 NCT06394531, which also lists 1 linked publication.
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 15 May 2026.