Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394531
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-27
Brief Title:
Effects of Jaboticaba Plinia Cauliflora Supplementation in Chronic Kidney Disease Patients
Sponsor:
Universidade Federal Fluminense
Organization:
Universidade Federal Fluminense
Study Overview
Official Title:
Jaboticaba Plinia Cauliflora as a Strategy to Modulate Inflammation Oxidative Stress and Gut Dysbiosis in Patients With Chronic Kidney Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 p005 and test power of 80 Randomization will be computerized in a 11 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 capsulesday providing 33g 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None