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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversidade Federal Fluminense

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients pregnant

Smokers

Using antibiotics in the last 3 months

Autoimmune diseases

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: InterventionActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
4 weeks
2

Inflammatory biomarker

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

Time frame
4 weeks
3

Microbiota Composition

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

Time frame
4 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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