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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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00749307
Enrollment
50
Registered
2008-09-09
Start date
2008-06-30
Completion date
2009-11-30
Last updated
2009-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia

Keywords

Heart rate variability, Docosahexaenoic acid, DHA, Long chain fatty acids, Long chain polyunsaturated fatty acids, Algal fatty acids, Schizochytrium, Omega 3, Death, Sudden, Cardiac, Arrhythmias, Cardiac

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTDocosahexaenoic acid (DHA)
DIETARY_SUPPLEMENTPlacebo

Sponsors

IRCCS San Raffaele
CollaboratorOTHER
DSM Nutritional Products, Inc.
CollaboratorINDUSTRY
Pharmanutra s.r.l.
CollaboratorUNKNOWN
Campus Bio-Medico University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Heart rate variability (HRV)basal - 12 weeks - 30 weeks

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026