Trial | NCT00749307  Report issue

Title

Effects of Docosahexaenoic Acid (DHA) on Heart Rate Variability in Elderly Patients
Effects of Supplementation With Algal Triacylglycerols Versus Placebo on Heart Rate Variability in Elderly Patients

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    50
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.
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.
Study Started
Jun 30
2008
Primary Completion
Sep 30
2009
Study Completion
Nov 30
2009
Last Update
Nov 25
2009
Estimate

Dietary Supplement Docosahexaenoic acid (DHA)

Dietary Supplement Placebo

1 Experimental

2 Placebo Comparator

Criteria 

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
No Results Posted