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

This study has been completed.
Sponsor:
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT00124852
First received: July 26, 2005
Last updated: January 11, 2011
Last verified: January 2011

July 26, 2005
January 11, 2011
October 2005
December 2006   (final data collection date for primary outcome measure)
  • Cognitive function
  • Depression
Same as current
Complete list of historical versions of study NCT00124852 on ClinicalTrials.gov Archive Site
Quality of life
Same as current
Not Provided
Not Provided
 
The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People
The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People: a Double-blind Placebo-controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Cognitive Impairment
  • Depression
Behavioral: n-3 Fatty Acid Supplementation
  • Placebo Comparator: High Oleic Sunflower Oil
    Intervention: Behavioral: n-3 Fatty Acid Supplementation
  • Active Comparator: 400 mg EPA+DHA/day
    low dose fish oil
    Intervention: Behavioral: n-3 Fatty Acid Supplementation
  • Active Comparator: 1800 mg EPA+DHA/day
    high dose fish oil
    Intervention: Behavioral: n-3 Fatty Acid Supplementation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
302
July 2007
December 2006   (final data collection date for primary outcome measure)

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
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00124852
2005_05/08, 6100.0004
No
Prof Dr Lisette CPGM de Groot, Wageningen University
ZonMw: The Netherlands Organisation for Health Research and Development
Not Provided
Study Director: Lisette de Groot, Dr Ir Project leader
Study Director: Marianne Geleijnse, Dr Project leader
Wageningen University
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP