Effects of Docosahexaenoic Acid (DHA) on Heart Rate Variability in Elderly Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Supplementation With Algal Triacylglycerols Versus Placebo on Heart Rate Variability in Elderly Patients

Conditions
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Arrhythmia

Intervention / Treatment
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* Dietary Supplement: Docosahexaenoic acid (DHA)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 65 years Exclusion Criteria: Treatment with or allergy to polyunsaturated fatty acids Diagnosis of arrhythmia or antiarrhythmic therapy Anticoagulant therapy (except acetylsalicylic acid) Pacemaker Bleeding diathesis Recent cerebral hemorrhage (less than 6 months) Thyroid dysfunction

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Dietary Supplement: Docosahexaenoic acid (DHA)<br> <br> |
| Placebo Comparator: 2<br> | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability (HRV) |  | basal - 12 weeks - 30 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DHA, Heart rate variability, Docosahexaenoic acid, Long chain fatty acids, Long chain polyunsaturated fatty acids, Algal fatty acids, Schizochytrium, Omega 3, Death, Sudden, Cardiac, Arrhythmias, Cardiac