Safety of phosphatidylserine containing omega-3 fatty acids in non-demented elderly: a double-blind placebo-controlled trial followed by an open-label extension
2011

Safety of Omega-3 Fatty Acids in Elderly with Memory Complaints

Sample size: 157 publication Evidence: moderate

Author Information

Author(s): Vakhapova Veronika, Richter Yael, Cohen Tzafra, Herzog Yael, Korczyn Amos D

Primary Institution: Tel-Aviv Sourasky Medical Center

Hypothesis

The study evaluates the safety profile of a novel phosphatidylserine preparation with omega-3 fatty acids in non-demented elderly individuals with memory complaints.

Conclusion

Consumption of PS-DHA is safe and well tolerated, showing no negative effects on the tested safety parameters.

Supporting Evidence

  • 131 participants completed the double-blind phase with no significant safety differences between groups.
  • 121 participants continued into the open-label phase, showing a reduction in resting diastolic blood pressure.
  • The treatment was well tolerated with gastrointestinal discomfort being the most common mild symptom.

Takeaway

Older people with memory issues can safely take a new supplement made from fish oil without getting sick.

Methodology

157 non-demented elderly participants were randomized to receive either PS-DHA or placebo for 15 weeks, followed by an open-label extension for 15 weeks.

Potential Biases

Potential bias due to funding from Enzymotec Ltd, the manufacturer of the PS-DHA supplement.

Limitations

The study did not assess long-term effects beyond 30 weeks and relied on self-reported adverse events.

Participant Demographics

Non-demented elderly individuals aged 50 to 90 with memory complaints.

Digital Object Identifier (DOI)

10.1186/1471-2377-11-79

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