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

Chronic Kidney Diseases Clinical Trial

Official title:

Jaboticaba (Plinia Cauliflora) as a Strategy to Modulate Inflammation, Oxidative Stress, and Gut Dysbiosis in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06394531
• Other study ID #: DeniseMafra20
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2027

Study information

• Verified date: April 2024
• Source: Universidade Federal Fluminense
• Contact: Denise Mafra, Phd
• Phone: +55 21 985683003
• Email: dmafra30[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Jaboticaba Peel Extract
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.

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

Locations

Country	Name	City	State
Brazil	Denise Mafra	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Inflammatory biomarker	Get blood samples to evaluate the supplementation effects in inflammatory biomarker- factor nuclear kappa B (NFkB)	4 weeks
Primary	Microbiota Composition	Get fecal samples to evaluate the supplementation effects in microbiota composition.	4 weeks