Completed

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

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What is being tested

Docosahexaenoic acid (DHA)

+ Placebo

Dietary Supplement
Who is being recruted

Arrhythmias, Cardiac+6

+ Cardiovascular Diseases

+ Death

Over 65 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 2 & 3
Interventional
Study Start: June 2008
See protocol details

Summary

Principal SponsorCampus Bio-Medico University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2008

Actual date on which the first participant was enrolled.

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.

Official TitleEffects of Supplementation With Algal Triacylglycerols Versus Placebo on Heart Rate Variability in Elderly Patients
NCT00749307
Principal SponsorCampus Bio-Medico University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacCardiovascular DiseasesDeathDeath, SuddenHeart ArrestHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDeath, Sudden, Cardiac

Criteria

1 inclusion criteria required to participate
Age above 65 years

7 exclusion criteria prevent from participating
Treatment with or allergy to polyunsaturated fatty acids

Diagnosis of arrhythmia or antiarrhythmic therapy

Anticoagulant therapy (except acetylsalicylic acid)

Pacemaker

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

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

Rome, ItalyOpen IRCCS San Raffaele Pisana. Department of Medical Sciences. Cardiovascular Research Unit. in Google Maps
CompletedOne Study Center