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

Sponsor
Universidade Federal Fluminense
Study ID
NCT06394531
Status
Not Yet Recruiting

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Conditions

  • Chronic Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
May 1, 2024
Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

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

Primary Outcome Measure

Primary Outcome Measure [ Time Frame: 4 weeks ]

Central Contacts

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