- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06286735
Effects of Cinnamomum Supplementation in Chronic Kidney Disease Patients
Effects of Cinnamomum Supplementation on Inflammation, Oxidative Stress, and Intestinal Microbiota in Patients With CKD.
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patients with CKD undergoing conservative treatment stages G3a-G4
- patient in stage 5 (GFR < 15 mL/min), undergoing hemodialysis for more than 6 months and having an arteriovenous fistula (AVF) as vascular access.
Exclusion Criteria:
- pregnant, lactating, smoker patients
- patients using antibiotics in the last 3 months, antioxidant supplements and habitual cinnamon intake
- patients with autoimmune and infectious diseases, cancer, liver disease and AIDS, illiterate people and people with disabilities (visual, hearing)
- patients who are allergic or intolerant to the components of the capsules.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention
60 capsules of 500 mg of powdered cinnamomum bark (cinnamomum verum; 40% polyphenols) each.
Participants in this group will be instructed to consume two capsules per day, one after lunch and the other after dinner for 3 months.
|
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 one after dinner for 3 months.
|
Placebo Comparator: Placebo
60 capsules with 500 mg of corn starch each.
Participants in this group will be instructed to consume two capsules per day, one after lunch and the other after dinner for 3 months.
|
60 capsules with 500 mg of corn starch per month, until the end of the three months of intervention.
Participants in this group will be instructed to consume two capsules per day, one after lunch and the other after dinner for 3 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of Nuclear factor kappa B (NF-KB)
Time Frame: 3 months
|
Inflammation transcription factor
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DeniseMafra18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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