Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
IRCCS San Raffaele
DSM Nutritional Products, Inc.
Pharmanutra s.r.l.
Information provided by:
Campus Bio-Medico University Identifier:
First received: September 8, 2008
Last updated: November 24, 2009
Last verified: November 2009
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.

Condition Intervention Phase
Dietary Supplement: Docosahexaenoic acid (DHA)
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Supplementation With Algal Triacylglycerols Versus Placebo on Heart Rate Variability in Elderly Patients

Further study details as provided by Campus Bio-Medico University:

Primary Outcome Measures:
  • Heart rate variability (HRV) [ Time Frame: basal - 12 weeks - 30 weeks ]

Estimated Enrollment: 50
Study Start Date: June 2008
Study Completion Date: November 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: Docosahexaenoic acid (DHA)
Placebo Comparator: 2 Dietary Supplement: Placebo

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.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00749307

IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit.
Rome, RM, Italy, 00163
Sponsors and Collaborators
Campus Bio-Medico University
IRCCS San Raffaele
DSM Nutritional Products, Inc.
Pharmanutra s.r.l.
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.
  More Information

Responsible Party: Francesco Maria Serino, Campus Bio-Medico University Identifier: NCT00749307     History of Changes
Other Study ID Numbers: ALFAHRV01
EudraCT number 2008-005715-18
Study First Received: September 8, 2008
Last Updated: November 24, 2009

Keywords provided by Campus Bio-Medico University:
Heart rate variability
Docosahexaenoic acid
Long chain fatty acids
Long chain polyunsaturated fatty acids
Algal fatty acids
Omega 3
Death, Sudden, Cardiac
Arrhythmias, Cardiac processed this record on April 26, 2017