HealthyNCT00615277
The Effect of Long-Chain Polyunsaturated Fatty Acids on Cognitive Performance and Mood
A study testing Omega-3 fatty acids in people with Healthy, run by University of Ulm.
Trial summary
The study investigates whether dietary intake of omega-3 long-chain polyunsaturated fatty acids affects learning and mood of healthy young adults. Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Omega-3 fatty acids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Jan 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 16 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy young adults
Who cannot join
- Coagulation disorder
About this study
Official title: The Effect of Long-Chain Polyunsaturated Fatty Acids on Cognitive Performance and Mood of Healthy Young Adults
The study investigates whether dietary intake of omega-3 long-chain polyunsaturated fatty acids affects learning and mood of healthy young adults.
Read the detailed description
The long-chain polyunsaturated fatty acids (LCPUFA) EPA (eicosapentaenoic acid), DHA (docosahexaenoic acid) of the omega-3 series and AA (arachidonic acid) of the omega-6 series are building blocks of all cell membranes and are found in high concentrations in retina and brain. Food sources of LA and ALA are vegetable oils, nuts and seeds. Since low conversion rates from ALA to DHA are a characteristic of human metabolism, adequate dietary provision with the long-chained omega-3 molecules depends primarily on individual eating habits. While AA is abundant in meat and dairy products, EPA and DHA are found in noteworthy concentrations only in certain species of fatty fish, such as salmon or mackerel.
The study investigates whether participants receiving an omega-3 supplement over a period of 4 month, perform better on a series of cognitive tests, than the participants allocated to the placebo group.
- Conditions
- Healthy
- Being tested
- Omega-3 fatty acids
- Keywords
- Young adults, Long-chain polyunsaturated fatty acids, Cognitive function, Mood, Supply with omega-3 fatty acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidsDietary supplement
600 mg EPA 120mg DHA daily, 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 1: omega-3 fatty acid supplement Receives: Dietary Supplement: Omega-3 fatty acids |
| 2 | Placebo comparator | 2: olive oil Receives: Dietary Supplement: Omega-3 fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition
Measured: Before intervention and after 16 weeks of intervention
Secondary outcomes (1)
Mood
Measured: Before intervention and after 16 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startOct 2006
- Primary completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Philipps University Marburg, Cognitive Drug Research Ltd
- Investigators
- Katharina A Widenhorn-Mueller, PhD, Principal investigator, University of UlmUlrike Weiland, MD, Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615277
- Sponsor's protocol ID
- 213/2005
- Other IDs
- 213/2005
- Status last verified
- Feb 2008
- First submitted
- 1 Feb 2008
- Last updated
- 14 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Long-Chain Polyunsaturated Fatty Acids on Cognitive Performance and Mood of Healthy Young Adults
- ClinicalTrials.gov ID
- NCT00615277
- Acronym / sponsor ID
- 213/2005
- Conditions
- Healthy
- Keywords
- Young adults, Long-chain polyunsaturated fatty acids, Cognitive function, Mood, Supply with omega-3 fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- Philipps University Marburg, Cognitive Drug Research Ltd
- Study start
- Oct 2006
- Primary completion
- Jan 2007 (actual)
- First posted
- 14 Feb 2008 (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 study investigates whether dietary intake of omega-3 long-chain polyunsaturated fatty acids affects learning and mood of healthy young adults.
Detailed description
The long-chain polyunsaturated fatty acids (LCPUFA) EPA (eicosapentaenoic acid), DHA (docosahexaenoic acid) of the omega-3 series and AA (arachidonic acid) of the omega-6 series are building blocks of all cell membranes and are found in high concentrations in retina and brain. Food sources of LA and ALA are vegetable oils, nuts and seeds. Since low conversion rates from ALA to DHA are a characteristic of human metabolism, adequate dietary provision with the long-chained omega-3 molecules depends primarily on individual eating habits. While AA is abundant in meat and dairy products, EPA and DHA are found in noteworthy concentrations only in certain species of fatty fish, such as salmon or mackerel.
The study investigates whether participants receiving an omega-3 supplement over a period of 4 month, perform better on a series of cognitive tests, than the participants allocated to the placebo group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Omega-3 fatty acids1: omega-3 fatty acid supplement |
| 2 | Placebo comparator | Dietary Supplement: Omega-3 fatty acids2: olive oil |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy young adults
Key exclusion criteria (1 listed)
- Coagulation disorder
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 |
|---|---|---|
| Omega-3 fatty acids600 mg EPA 120mg DHA daily, 16 weeks | Dietary supplement | 1, 2 |
Primary outcome
Cognition
Time frame: Before intervention and after 16 weeks of intervention
1 secondary outcome
Mood
Time frame: Before intervention and after 16 weeks of intervention
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 14 Feb 2008.
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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.
Katharina A Widenhorn-Mueller, PhD principal investigator
University of Ulm
Ulrike Weiland, MD principal investigator
University of Ulm
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 fatty acids in people with Healthy, run by University of Ulm.
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 1 inclusion and 1 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 14 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Cognition (time frame: Before intervention and after 16 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2008.