Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286735
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-02-11
Brief Title:
Effects of Cinnamomum Supplementation in Chronic Kidney Disease Patients
Sponsor:
Universidade Federal Fluminense
Organization:
Universidade Federal Fluminense
Study Overview
Official Title:
Effects of Cinnamomum Supplementation on Inflammation Oxidative Stress and Intestinal Microbiota in Patients With CKD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
Patients with chronic kidney disease CKD experience many complications related to inflammation and oxidative stress that are closely related to the progression of kidney failure and increased mortality Furthermore these patients may have intestinal dysbiosis associated with persistent uremia generating greater production of uremic toxins arising from the metabolism of intestinal bacteria and also helping to maintain the inflammatory process and oxidative stress In this context some nutritional strategies have been proposed as an adjuvant therapeutic alternative to modulate inflammation and improve the antioxidant response of patients with CKD and even more so to modulate the intestinal microbiota Based on the consolidated knowledge of the role of nutrients and bioactive compounds on the expression of genes related to inflammation oxidative stress and also the modulation of the intestinal microbiota cinnamon a member of the Lauraceae family has been widely used as a spice and traditional herbal medicine for centuries and has indicated beneficial benefits in cardiovascular diseases obesity diabetes The bioactive compounds in cinnamomum such as cinnamaldehyde cinnamic acid and cinnamate can attenuate oxidative stress inflammation hyperglycemia intestinal dysbiosis and dyslipidemia which are common complications in CKD patients Therefore the present project proposes a longitudinal clinical trial study that aims to evaluate the effects of cinnamomum on transcription factors and inflammatory markers oxidative stress and modulation of intestinal health in patients with CKD on hemodialysis
Detailed Description:
This is a longitudinal study of the randomized double-blind placebo-controlled clinical trial type randomized controlled trial - RCT where patients will be allocated into two groups intervention group 15 patients on conservative treatment and 15 patients on hemodialysis and placebo group 15 patients on conservative treatment and 15 patients on hemodialysis In the intervention group participants will receive a capsule containing 60 capsules of 500 mg of powdered cinnamomum bark cinnamomum verum 40 polyphenols Participants in this group will be instructed to consume two capsules per day one after lunch and the other after dinner for 3 months and every month the research team will provide a bottle containing 60 capsules of 500 mg of cinnamomum bark powder Cinnamomum verum 40 polyphenols The placebo group will receive 60 capsules with 500 mg of cornstarch per month until the end of the three months of intervention and the guidelines will be the same as those given to the intervention group
Randomization will be performed after inclusion and exclusion criteria are verified Eligible patients will be assigned 11 to both study arms according to a computer-generated list of treatment codes An independent appropriately trained statistician will assign participants to intervention and placebo groups at random Randomization and allocation will be concealed from researchers and participants until main analyzes are completed
Blood tests assessment of food intake and anthropometric measurements will be carried out at the beginning of the follow-up and at the end of three months of treatment with no additional need for the patient to travel to the collection sites This will be carried out on hemodialysis days or pre-scheduled routine appointments If extra travel is necessary the patient will be reimbursed for transportation costs Each month researchers will go to the hemodialysis clinic to check adherence to treatment by counting capsules and subsequently delivering new pots for use in the following month until the three months of study are completed In addition researchers will contact participants by phone weekly to monitor possible side effects possible questions and adherence
Randomization will be performed after inclusion and exclusion criteria are verified Eligible patients will be assigned 11 to both study arms according to a computer-generated list of treatment codes An independent appropriately trained statistician will assign participants to intervention and placebo groups at random Randomization and allocation will be concealed from researchers and participants until main analyzes are completed
Blood tests assessment of food intake and anthropometric measurements will be carried out at the beginning of the follow-up and at the end of three months of treatment with no additional need for the patient to travel to the collection sites This will be carried out on hemodialysis days or pre-scheduled routine appointments If extra travel is necessary the patient will be reimbursed for transportation costs Each month researchers will go to the hemodialysis clinic to check adherence to treatment by counting capsules and subsequently delivering new pots for use in the following month until the three months of study are completed In addition researchers will contact participants by phone weekly to monitor possible side effects possible questions and adherence
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