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

Sponsor

Campus Bio-Medico University (Other)

Overall Status

Completed

CT.gov ID

NCT00749307

Collaborator

IRCCS San Raffaele (Other), DSM Nutritional Products, Inc. (Industry), Pharmanutra s.r.l. (Other)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmia	Dietary Supplement: Docosahexaenoic acid (DHA) Dietary Supplement: Placebo	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Dietary Supplement: Docosahexaenoic acid (DHA)

Placebo Comparator: 2

Dietary Supplement: Placebo

Outcome Measures

Primary Outcome Measures

Heart rate variability (HRV) [basal - 12 weeks - 30 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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.

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.