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Completed

NCT Number: NCT00124852

The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People

The efficacy of EPA-DHA supplementation will be assessed in a randomized placebo-controlled trial with cognitive decline and early signs of depression as primary outcome measures.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University

Wageningen, Gelderland, 6700 EV, Netherlands

About this study

The efficacy of EPA-DHA supplementation will be assessed in a randomized placebo-controlled trial with cognitive decline and early signs of depression as primary outcome measures. In this study 300 elderly people will be randomly allocated to one of three treatments. Two groups will receive fish oil capsules with different doses EPA/DHA (a normal dose or a high dose) and the third group will receive placebo capsules. At the start and at the end of the intervention period cognitive function, the occurrence of depression, quality of life, anthropometric values and biochemical indicators will be measured.

After completion of the trial a workshop will be organized in which the outcomes of the proposed study will be presented to representatives of several key areas concerning mental health of elderly people.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women
  • Aged 65 years and over
  • Informed consent signed

Exclusion criteria

  • A score of > 16 on the CES-D (Centre for Epidemiological Studies-Depression Scale
  • A score of < 21 points on MMSE (Mini-Mental State Examination)
  • Current or recent (<4 weeks) use of fish oil supplements or intake of more than 4 times fish as judged by a fish consumption questionnaire
  • Current use of pharmacological antidepressants
  • Current use of dementia (Alzheimer) medication
  • Serious liver disease
  • Use of more than 4 glasses of alcohol per day
  • Unable to participate as judged by the responsible medical physician
  • Allergy to fish(oil)
  • Swallowing problems
  • Participation in another clinical trial less than 2 months before the start of the trial or at the same time

Treatment and study plan

n-3 Fatty Acid Supplementation

Behavioral

Primary outcomes

  1. Cognitive function

  2. Depression

Secondary outcomes

  1. Quality of life

Sponsors and collaborators

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Other

Registry information

Official study title

The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People: a Double-blind Placebo-controlled Trial

Important dates

Study start
2005
Primary completion
2006
Study completion
2007
First posted
Jul 28, 2005
Registry last updated
Jan 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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