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OpenTrials
Completed

NCT Number: NCT00749307

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.

Rome, RM, 00163, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Docosahexaenoic acid (DHA)

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Heart rate variability (HRV)

    Time frame: basal - 12 weeks - 30 weeks

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Collaborators

  • IRCCS San Raffaele
  • Pharmanutra s.r.l.
  • dsm-firmenich Switzerland AG

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 9, 2008
Registry last updated
Nov 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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