Resveratrol, Cardiovascular Risk Markers And Cognitive Performance In Patients With Schizophrenia
Effects of Reveratrol on Cardiovascular Risk Markers and Cognitive Performance in Patients With Schizophrenia: a Randomized Clinical Trilal
2 other identifiers
interventional
19
1 country
1
Brief Summary
Resveratrol supplementation may improve cardiovascular risk factors and cognitive parameters in patients with schizophrenia taking antipsychotics?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 schizophrenia
Started Mar 2014
Shorter than P25 for phase_2 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2014
CompletedFirst Posted
Study publicly available on registry
February 13, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedDecember 8, 2015
December 1, 2015
10 months
January 15, 2014
December 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of cardiovascular risk will be realized by measurement of cytokine levels, C-reactive protein and cholesterol levels.
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.
1 month
Secondary Outcomes (1)
Cognitive performance will be assessed with a battery of cognitive tests and BPRS (brief psychiatric rating scale) to assess symptoms.
1 month
Other Outcomes (1)
Nutritional evaluation will be conducted by anthropometric data and food intake by 24-hour Recall Survey.
1 month
Study Arms (2)
resveratrol
ACTIVE COMPARATORcorn starch
PLACEBO COMPARATOR(10 patients) 100mg 2x/day 1 month
Interventions
100mg 2x/day 1 month
Eligibility Criteria
You may qualify if:
- Men 18-65 years old, diagnosed with schizophrenia according to DSM-IV and ICD-10, which are in clozapine medication for at least 6 months.
You may not qualify if:
- Patients will be excluded from the study:
- Have a diagnosis of diabetes
- Use other antipsychotic drugs, clozapine beyond
- Using medicines for diabetes or dyslipidaemia
- Accept not participate in any stage of the research.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HCPA
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Related Publications (1)
Zortea K, Franco VC, Francesconi LP, Cereser KM, Lobato MI, Belmonte-de-Abreu PS. Resveratrol Supplementation in Schizophrenia Patients: A Randomized Clinical Trial Evaluating Serum Glucose and Cardiovascular Risk Factors. Nutrients. 2016 Jan 29;8(2):73. doi: 10.3390/nu8020073.
PMID: 26840331DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master
Study Record Dates
First Submitted
January 15, 2014
First Posted
February 13, 2014
Study Start
March 1, 2014
Primary Completion
January 1, 2015
Study Completion
May 1, 2015
Last Updated
December 8, 2015
Record last verified: 2015-12