Finding studies
Finding studies
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Lead
Universidade Federal Fluminense
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.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
