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

November 24, 2009 updated by: Campus Bio-Medico University

Effects of Supplementation With Algal Triacylglycerols Versus Placebo 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00163
        • IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Dietary supplement: Docosahexaenoic acid (DHA)
Placebo Comparator: 2
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bio-Medico University

Collaborators

IRCCS San Raffaele
DSM Nutritional Products, Inc.
Pharmanutra s.r.l.

Investigators

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

September 8, 2008

First Submitted That Met QC Criteria

September 8, 2008

First Posted (Estimate)

September 9, 2008

Study Record Updates

Last Update Posted (Estimate)

November 25, 2009

Last Update Submitted That Met QC Criteria

November 24, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALFAHRV01
  • EudraCT number 2008-005715-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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