Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05183737 |
| Other study ID # |
DeniseMafra13 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 7, 2022 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Universidade Federal Fluminense |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Oxidative stress and inflammation are correlated with Chronic Kidney Disease (CKD), in a way
that they bring several harms to patients, including an increased risk of cardiovascular
disease and mortality. Adjuvant therapeutic options such as bioactive compounds present in
some foods seem to mitigate inflammation. Turmeric and propolis are foods that have compounds
with antioxidant and anti-inflammatory capacity, as they promote the activation of nuclear
erythroid transcription factor 2 (Nrf2 - responsible for the synthesis of antioxidant
enzymes) and inhibit the activity of nuclear factor Kappa B (NF-κB - which increases the
synthesis of inflammatory cytokines). This work aims to evaluate the effects of
supplementation of associated propolis and turmeric microcapsules on inflammatory markers in
patients with CKD undergoing hemodialysis (HD).
Description:
The so-called Chronic Non-Communicable Diseases (NCDs) have been increasing in incidence.
Among these, one can mention Chronic Kidney Disease (CKD). CKD is considered a public health
problem and is characterized by an irreversible syndrome resulting from changes in the
function or structure of the kidney, which has a progressive evolution.
Oxidative stress is one of the most potent inducers of inflammation, being an imbalance
between the production of reactive oxygen species (ROS) and cellular antioxidant capacity, so
that such imbalance can influence the activation of the nuclear factor kB (NF-κB),
inflammation-associated interleukins, and tumor necrosis factor alpha 4 (TNF-α), which are
promoters of cell damage and organic molecules. Patients with CKD on HD showed increased
expression of NF-κB and reduced expression of Nrf2, so it is important to perform studies
that propose ways to increase the performance of Nrf2, as well as reduce the activation of
NF-κB. the performance of propolis and turmeric.
The study aims to evaluate the effects of supplementation of propolis and turmeric
microcapsules on inflammatory markers and clinical parameters in patients with chronic kidney
disease undergoing hemodialysis.
Sample calculation was performed using the G-Power 3.1 software, with a test power of 80%,
considering the expression of NF-κB as the main outcome, significance level of 5%
(two-tailed), effect size of 1, 32. The sample obtained consisted of 34 patients (17 in each
group).
The proposed clinical study is a longitudinal randomized and double-blind (randomized
controlled trial - RCT) where patients will receive capsules containing microencapsulated
turmeric and propolis, twice a day, for 12 weeks. The mixture of microcapsules of propolis
and turmeric will be distributed to participants in the form of hard gelatine capsules. The
placebo group will receive the same amount of capsules, at the same times, containing gum
arabic and corn starch. Randomization will be computerized in a 1:1 ratio.
- Anthropometric assessments, food intake, blood collections will be performed at the
beginning of the follow-up and in subsequent consultations;
- The analysis of possible adverse effects will be collected through a separate analysis
form;
- The assessment of food intake will be performed through the 3-day 24-hour recall;
- The assessment of nutritional status will be performed using anthropometric data;
- Blood samples will be collected in the morning, after fasting for 12 hours, before the
dialysis procedure;
- NF-κB expression will be analyzed by means of peripheral blood nuclear cells (PBMCs)
using real-time quantitative polymerase chain reaction (qPCR);
- For the measurement of inflammatory cytokines IL-6 and TNF-α, commercial ELISA kits will
be used;
- C-reactive protein (CRP) will be determined by chemiluminescence;
- Lipid peroxidation will be estimated by determining thiobarbituric acid reactive
substances (TBARS), including MDA, using the modified Ohkawa method;
- The evaluation of the total antioxidant capacity of the plasma will be determined by
ELISA;
The effect of supplementation (∆) on each variable will be defined as the subject of the
difference between the variable at the end of supplementation with propolis and turmeric and
the value of the variable at the end of placebo administration. Statistical analyzes will be
performed using SPSS version 22.0.
