Effects of Docosahexaenoic Acid (DHA) on Heart Rate Variability in Elderly Patients
The purpose of this study is to test the hypothesis that dietary supplementation with an algal source of docosahexaenoic acid (DHA) can improve the heart rate variability in elderly patients.
Dietary Supplement: Docosahexaenoic acid (DHA)
Dietary Supplement: Placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effects of Supplementation With Algal Triacylglycerols Versus Placebo on Heart Rate Variability in Elderly Patients|
- Heart rate variability (HRV) [ Time Frame: basal - 12 weeks - 30 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||November 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
|Experimental: 1||Dietary Supplement: Docosahexaenoic acid (DHA)|
|Placebo Comparator: 2||Dietary Supplement: Placebo|
In western countries, sudden cardiac death (SCD) represents the most common form of cardiovascular death. SCD is often caused by ventricular arrhythmias in patients with a known history of ischemic heart disease but it may also occurs in healthy persons.
In the last years has been extensively studied the protective role of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) against SCD both in healthy persons and in patients affected by coronary artery disease.
The hypothesis that these evidences could be ascribed to an antiarrhythmic effect of n-3 LCPUFA, has been corroborated by the observation of a direct relationship between the dietary intake of these nutrients and a better cardiac autonomic control.
This pathway, in particular, has been confirmed by the analysis of changes in heart rate variability.
Most studies in this field used n-3 LCPUFA derived from fish oil, composed by a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). At our knowledge there are few studies available evaluating the isolated role of DHA, derived from alternative sources of n-3 LCPUFA, as the microalgae, in the prevention of fatal arrhythmias.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749307
|IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.|
|Rome, RM, Italy, 00163|
|Study Director:||Raffaele Antonelli Incalzi, MD||Campus Bio-Medico University|
|Study Director:||Giuseppe Rosano, MD||IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.|
|Principal Investigator:||Francesco M Serino, MD||Campus Bio-Medico University|
|Principal Investigator:||Marco Miceli, MD||IRCCS San Raffaele Pisana. Department of Sciences. Cardiovascular Research Unit.|