Cognitive ImpairmentNCT00124852
The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People
A study testing n-3 Fatty Acid Supplementation in people with Cognitive Impairment and Depression, run by ZonMw: The Netherlands Organisation for Health Research and Development at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Depression
- What is being tested?
- n-3 Fatty Acid Supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 302 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2005to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women
- Aged 65 years and over
- Informed consent signed
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Cognitive Impairment, Depression
- Being tested
- n-3 Fatty Acid Supplementation
- Keywords
- cognition, depression, elderly
- Medical subject headings
- Cognitive Dysfunction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-3 Fatty Acid SupplementationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| High Oleic Sunflower Oil | Placebo comparator | Not described Receives: Behavioral: n-3 Fatty Acid Supplementation |
| 400 mg EPA+DHA/day | Active comparator | low dose fish oil Receives: Behavioral: n-3 Fatty Acid Supplementation |
| 1800 mg EPA+DHA/day | Active comparator | high dose fish oil Receives: Behavioral: n-3 Fatty Acid Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Depression
Secondary outcomes (1)
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2005 (estimated)
- Study startOct 2005
- Primary completionDec 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZonMw: The Netherlands Organisation for Health Research and Development
- Sponsor type
- University, hospital or other
- Investigators
- Lisette de Groot, Dr Ir, Study director, Project leaderMarianne Geleijnse, Dr, Study director, Project leader
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124852
- Sponsor's protocol ID
- 2005_05/08
- Other IDs
- 6100.0004
- Status last verified
- Jan 2011
- First submitted
- 26 Jul 2005
- Last updated
- 12 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Bouwens M, van de Rest O, Dellschaft N, Bromhaar MG, de Groot LC, Geleijnse JM, Muller M, Afman LA. Fish-oil supplementation induces antiinflammatory gene expression profiles in human blood mononuclear cells. Am J Clin Nutr. 2009 Aug;90(2):415-24. doi: 10.3945/ajcn.2009.27680. Epub 2009 Jun 10.
PubMed 19515734van de Rest O, Geleijnse JM, Kok FJ, van Staveren WA, Hoefnagels WH, Beekman AT, de Groot LC. Effect of fish-oil supplementation on mental well-being in older subjects: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2008 Sep;88(3):706-13. doi: 10.1093/ajcn/88.3.706.
PubMed 18779287
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People: a Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00124852
- Acronym / sponsor ID
- 2005_05/08
- Conditions
- Cognitive Impairment, Depression
- Keywords
- cognition, depression, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- ZonMw: The Netherlands Organisation for Health Research and DevelopmentUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 28 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Oleic Sunflower Oil | Placebo comparator | Behavioral: n-3 Fatty Acid Supplementation |
| 400 mg EPA+DHA/day | Active comparator | Behavioral: n-3 Fatty Acid Supplementationlow dose fish oil |
| 1800 mg EPA+DHA/day | Active comparator | Behavioral: n-3 Fatty Acid Supplementationhigh dose fish oil |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Men and women
- Aged 65 years and over
- Informed consent signed
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| n-3 Fatty Acid Supplementation | Behavioural | 1800 mg EPA+DHA/day, 400 mg EPA+DHA/day, High Oleic Sunflower Oil |
Primary outcome
Cognitive function
Depression
1 secondary outcome
Quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2011.
- Derived from this study: PubMed 19515734Bouwens M, van de Rest O, Dellschaft N, Bromhaar MG, de Groot LC, Geleijnse JM, Muller M, Afman LA. Fish-oil supplementation induces antiinflammatory gene expression profiles in human blood mononuclear cells. Am J Clin Nutr. 2009 Aug;90(2):415-24. doi: 10.3945/ajcn.2009.27680. Epub 2009 Jun 10.
- Derived from this study: PubMed 18779287van de Rest O, Geleijnse JM, Kok FJ, van Staveren WA, Hoefnagels WH, Beekman AT, de Groot LC. Effect of fish-oil supplementation on mental well-being in older subjects: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2008 Sep;88(3):706-13. doi: 10.1093/ajcn/88.3.706.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisette de Groot, Dr Ir study director
Project leader
Marianne Geleijnse, Dr study director
Project leader
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing n-3 Fatty Acid Supplementation in people with Cognitive Impairment and Depression, run by ZonMw: The Netherlands Organisation for Health Research and Development at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00124852, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2011.