Effects of Jaboticaba (Plinia Cauliflora) Supplementation in Chronic Kidney Disease Patients

NCT06394531 | Not Yet Recruiting

• 1 other identifier: DeniseMafra20
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Kidney Diseases

Keywords

chronic kidney diseases; jaboticaba; inflammation; oxidative stress; microbitoa

Outcome Measures

Primary Outcomes (3)

• 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)

  4 weeks

• Inflammatory biomarker

  Get blood samples to evaluate the supplementation effects in inflammatory biomarker- factor nuclear kappa B (NFkB)

  4 weeks

• Microbiota Composition

  Get fecal samples to evaluate the supplementation effects in microbiota composition.

  4 weeks

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Jaboticaba Peel Extract DIETARY_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.

Intervention

Placebo OTHER

Placebo. Patients will ingest 4 capsules/day of placebo (corn starch), providing 3.3g of placebo, for one month.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Denise Mafra

Rio de Janeiro, Rio de Janeiro, 22260050, Brazil

Location

Related Publications (1)

• 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.

  PMID: 37761200 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Inflammation

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

Study Officials

• Denise Mafra, Phd

  Universidade Federal Fluminense

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Mafra, Phd

CONTACT

+55 21 985683003; dmafra30@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossover Assignment

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 1, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)