Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06286735 |
| Other study ID # |
DeniseMafra18 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 22, 2024 |
| Est. completion date |
December 22, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Universidade Federal Fluminense |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 1:1 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.
