The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People
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ClinicalTrials.gov Identifier: NCT00124852 |
Recruitment Status :
Completed
First Posted : July 28, 2005
Last Update Posted : January 12, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cognitive Impairment Depression | Behavioral: n-3 Fatty Acid Supplementation | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 302 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People: a Double-blind Placebo-controlled Trial |
Study Start Date : | October 2005 |
Actual Primary Completion Date : | December 2006 |
Actual Study Completion Date : | July 2007 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: High Oleic Sunflower Oil |
Behavioral: n-3 Fatty Acid Supplementation |
Active Comparator: 400 mg EPA+DHA/day
low dose fish oil
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Behavioral: n-3 Fatty Acid Supplementation |
Active Comparator: 1800 mg EPA+DHA/day
high dose fish oil
|
Behavioral: n-3 Fatty Acid Supplementation |
- Cognitive function
- Depression
- Quality of life

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124852
Netherlands | |
Wageningen University | |
Wageningen, Gelderland, Netherlands, 6700 EV |
Study Director: | Lisette de Groot, Dr Ir | Project leader | |
Study Director: | Marianne Geleijnse, Dr | Project leader |
Responsible Party: | Prof Dr Lisette CPGM de Groot, Wageningen University |
ClinicalTrials.gov Identifier: | NCT00124852 |
Other Study ID Numbers: |
2005_05/08 6100.0004 |
First Posted: | July 28, 2005 Key Record Dates |
Last Update Posted: | January 12, 2011 |
Last Verified: | January 2011 |
cognition depression elderly |
Depression Behavioral Symptoms |