Cognitive EnhancementFINSNCT01951937
Fish Intervention and Learning Abilities
A study testing Fish Meals in people with Cognitive Enhancement, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
In the FINS study we test - in a randomized non blinded intervention study- the hypothesis that increased intake of salmon will improve cognitive performance of children aged 4 years to 6 years in the Munich area (Germany), who habitually consume little fish. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Enhancement
- What is being tested?
- Fish Meals
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Dec 2019
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 4-6 years
Who cannot join
- severe illness
- child dislikes fish
Trial locations and contacts
1 site in 1 country.
Germany1 site
Div. Metabolic and Nutritional Medicine Dr. von Hauner Children's Hospital Univ. of Munich Medical Centre
Munich, Bavaria, 80337
About this study
Official title: Fish Intervention and Learning Abilities in German Youths
In the FINS study we test - in a randomized non blinded intervention study- the hypothesis that increased intake of salmon will improve cognitive performance of children aged 4 years to 6 years in the Munich area (Germany), who habitually consume little fish.
Read the detailed description
Long chain polyunsaturated fatty acids (LC-PUFA) of the n-3 series, eicosapentaenoic acid (EPA) and most prominently docosahexaenoic acid (DHA), are considered important for neural development during pre- and postnatal development.
- Conditions
- Cognitive Enhancement
- Being tested
- Fish Meals, Placebo
- Keywords
- Cognitive Test, Omega-3 Fatty acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish MealsDietary supplement
Meals containing salmon
PlaceboDietary supplement
No fish meals
| Study group | Role | What they receive |
|---|---|---|
| Fish Meals | Active comparator | 3 Fish meals per week for 4 months Receives: Dietary Supplement: Fish Meals |
| Placebo | Placebo comparator | Habitual diet Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Performance
Measured: Change from baseline at 4 months later
Secondary outcomes (3)
Change of cheek cell glycerophospholipids docosahexaenoic and eicosapentaenoic percentage
Measured: Change from baseline at 4 months later
Change of red blood cell fatty acids (omega-3 index),plasma phospholipid species and plasma vitamin D3
Measured: Change from baseline at 4 months later
Change of iodine levels in urine
Measured: Change from baseline at 4 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startSep 2014
- Primary completionNov 2015
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive EnhancementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nutrition and Seafood Research, Norway
- Responsible party
- Principal investigator, Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich
- Investigators
- Berthold Koletzko, Dr med habil, Study director, Head, Div. Metabolic and Nutritional Medicine Dr. von Hauner Children's Hospital Univ. of Munich Medical Centre - Klinikum d. Univ. München Lindwurmstr. 4, D-80337 Muenchen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951937
- Sponsor's protocol ID
- FINS-547
- Acronym
- FINS
- Status last verified
- Aug 2022
- First submitted
- 20 Sep 2013
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Demmelmair H, Oyen J, Pickert T, Rauh-Pfeiffer A, Stormark KM, Graff IE, Lie O, Kjellevold M, Koletzko B. The effect of Atlantic salmon consumption on the cognitive performance of preschool children - A randomized controlled trial. Clin Nutr. 2019 Dec;38(6):2558-2568. doi: 10.1016/j.clnu.2018.11.031. Epub 2018 Dec 22.
PubMed 30598384
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fish Intervention and Learning Abilities in German Youths
- ClinicalTrials.gov ID
- NCT01951937
- Acronym / sponsor ID
- FINS / FINS-547
- Conditions
- Cognitive Enhancement
- Keywords
- Cognitive Test, Omega-3 Fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- National Institute of Nutrition and Seafood Research, Norway
- Study start
- Sep 2014 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 27 Sep 2013 (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.
In the FINS study we test - in a randomized non blinded intervention study- the hypothesis that increased intake of salmon will improve cognitive performance of children aged 4 years to 6 years in the Munich area (Germany), who habitually consume little fish.
Detailed description
Long chain polyunsaturated fatty acids (LC-PUFA) of the n-3 series, eicosapentaenoic acid (EPA) and most prominently docosahexaenoic acid (DHA), are considered important for neural development during pre- and postnatal development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish Meals | Active comparator | Dietary Supplement: Fish Meals3 Fish meals per week for 4 months |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboHabitual diet |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 4-6 years
Key exclusion criteria (2 listed)
- severe illness
- child dislikes fish
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 |
|---|---|---|
| Fish MealsMeals containing salmon | Dietary supplement | Fish Meals |
| PlaceboNo fish meals | Dietary supplement | Placebo |
Primary outcome
Change in Cognitive Performance
Time frame: Change from baseline at 4 months later
3 secondary outcomes
Change of cheek cell glycerophospholipids docosahexaenoic and eicosapentaenoic percentage
Time frame: Change from baseline at 4 months later
Change of red blood cell fatty acids (omega-3 index),plasma phospholipid species and plasma vitamin D3
Time frame: Change from baseline at 4 months later
Change of iodine levels in urine
Time frame: Change from baseline at 4 months later
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 22 Aug 2022.
- Results publication: PubMed 30598384Demmelmair H, Oyen J, Pickert T, Rauh-Pfeiffer A, Stormark KM, Graff IE, Lie O, Kjellevold M, Koletzko B. The effect of Atlantic salmon consumption on the cognitive performance of preschool children - A randomized controlled trial. Clin Nutr. 2019 Dec;38(6):2558-2568. doi: 10.1016/j.clnu.2018.11.031. Epub 2018 Dec 22.
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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.
Berthold Koletzko, Dr med habil study director
Head, Div. Metabolic and Nutritional Medicine Dr. von Hauner Children's Hospital Univ. of Munich Medical Centre - Klinikum d. Univ. München Lindwurmstr. 4, D-80337 Muenchen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Meals in people with Cognitive Enhancement, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 2 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 22 Aug 2022. 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 Germany. 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?
Change in Cognitive Performance (time frame: Change from baseline at 4 months later). 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 NCT01951937, which also lists 1 linked publication.
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 22 Aug 2022.