Resveratrol, Cardiovascular Risk Markers And Cognitive Performance In Patients With Schizophrenia
Resveratrol supplementation may improve cardiovascular risk factors and cognitive parameters in patients with schizophrenia taking antipsychotics?
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effects of Reveratrol on Cardiovascular Risk Markers and Cognitive Performance in Patients With Schizophrenia: a Randomized Clinical Trilal|
- Assessment of cardiovascular risk will be realized by measurement of cytokine levels, C-reactive protein and cholesterol levels. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Assessment of cardiovascular risk will be realized by measurement of cytokine levels (IL-12p70, IL-6, IL-10, IL-1b, IL-8 and TNF-α), C-reactive protein and cholesterol levels (total cholesterol, LDL, HDL, triglycerides) in patients with schizophrenia before and after supplementation with resveratrol or placebo.
- Cognitive performance will be assessed with a battery of cognitive tests and BPRS (brief psychiatric rating scale) to assess symptoms. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Cognitive performance will be assessed with a battery of cognitive tests (Hopkins, for verbal memory; Stroop: for executive function; Digits WAIS-III, for attention; and Sequence numbers and letters for verbal memory and attention) and BPRS (brief psychiatric rating scale) to assess symptoms.
- Nutritional evaluation will be conducted by anthropometric data and food intake by 24-hour Recall Survey. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Nutritional evaluation will be conducted by anthropometric data (weight, height, waist and hip circumference, body fat percentage) and food intake by 24-hour Recall Survey (24HR).
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||April 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: resveratrol||
Placebo Comparator: corn starch
(10 patients) 100mg 2x/day
Randomized, double-blind, placebo-controlled trial comparing supplementation with resveratrol or placebo in patients diagnosed with schizophrenia.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02062190
|Contact: Karine Zortéaemail@example.com|
|Porto Alegre, RS, Brazil, 90035-903|
|Contact: Karine Zortéa, MD 84296901 firstname.lastname@example.org|
|Principal Investigator: Karine Zortéa, MD|