Primary objective of this study is to evaluate the short term (6 months) and long term (12 months and maybe 24 months) effects of a krill oil based omega-3 supplement on learning, cognitive performance and behavior.Secundary goal of this study is to…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Geen; het onderzoek heeft geen betrekking op een aandoening. Het betreft gezonde deelnemers. Uiteindelijk wordt wel gekeken naar de verandering in cognitieve prestatie en mentaal welbevinden
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Academic achievement (grade point average for Dutch, English, and
mathematics)
2. Cognitive performance
Speed of information processing(Symbol Digit Modalities Test, Trail Making
Test)
Attention (D2 Test of Attention)
Working memory (N-back Taak)
3. Behavior
Absenteeism (schools will provide a list)
Motivation (MSLQ)
Goal orientation (Achievement Goal Questionnaire)
Mood (CES-D)
Self-esteem (Rosenberg Self-esteem Scale)
Secondary outcome
Perceptual processing measured with eye tracking (in sub-sample only)
Background summary
Previous research in (unborn) babies, children with a disorder, and elderly
suggest that fish fatty acids / omega-3 fatty acids play a role in brain
functioning. The period of adolescence was, until recently, for the most part
neglected though it has been shown that the brain of adolescents, and
especially the prefrontal cortex, continues to mature until their late
twenties. Because of the continuing brain development during adolescence, it is
important to take into account the role of the omega-3 fatty acids, also
because the omega-3 fatty acids DHA and EPA are important structural components
of the neural cell membranes and influence in this respect membrane fluidity
and signal transduction and finally learning, cognition, and behaviour.
Therefore in the current study the effect of one year supplementation with
omega-3 fatty acids from krill oil will be investigated in healthy 14-15 years
old adolescents from lower vocational training on learning, cognitive
performance, and behaviour.
This study answers the question whether omega-3 fatty acid supplementation from
krill oil is useful to improve school performance.
Study objective
Primary objective of this study is to evaluate the short term (6 months) and
long term (12 months and maybe 24 months) effects of a krill oil based omega-3
supplement on learning, cognitive performance and behavior.
Secundary goal of this study is to investigate the effect of above-mentioned
supplement on visual processing measured by eye tracking.
We expect that in the intervention group the omega-3 status will increase
significantly and will result in increments in learning, cognitive performance,
and behavior.
Study design
A double-blind randomized controlled dietary intervention trial will be set up.
350 participants with low omega-3 index will be ad random allocated to an
intervention or placebo group. After 6, 12, and (maybe) 24 months the effects
on cognitive performance (performance on several neurocognitive tests) behavior
(absenteeism, motivation, goal orientation, mood, and self-esteem) and in a
sub-group visual processing by means of eye tracking will be determined.
At baseline, after 3 months and 12 months blood by finger prick is collected to
determine fatty acid status. In case necessary dose adjustments will be made.
In addition at baseline a saliva sample will be collected. Recent studies
indicate that the reaction on a fatty acid supplement may be dependent from the
ApoE status. In case of a null finding ApoE status in saliva will be
determined.
Intervention
Participants will be randomly allocated to a placebo or an intervention group.
Participants in the intervention group will consume 2 g of krill oil a day.
This will result in the intake of the recommended daily amount of 450 mg of
EPA/DHA per day.
The placebo has a fatty acid composition resembling the average European diet
Study burden and risks
Participation in the study will bring minimal or no risks. Participants are
asked to take a daily Krill oil supplement together with the main course. In
addition they are asked to complete several neuropsychological tests and
questionnaires. This takes place in the class room in regular school time (4
times 1 lesson (50 min) per calendar year). In addition a subgroup of 60
students is asked to invest three times 25 minutes to participate in the
sub-study regarding eye tracking.
All participants are asked to provide one saliva sample and four times blood
from a finger prick.
Valkenburgerweg 177
Heerlen 6419 AT
NL
Valkenburgerweg 177
Heerlen 6419 AT
NL
Listed location countries
Age
Inclusion criteria
Healthy adolescents
14-15 years old
Mother tongue is Dutch
Participating in lower general secondary education (it represents a group with a lower socio economic status and in this way it is assumed that we preselect a group with a low omega-3 index which might benefit most from a supplement like ours).
Only the first 350 students with an omega-3 index < 5% at baseline will be allocated to participate in the intervention study.
Exclusion criteria
Medical disorders associated with learning deficits such as ADHD, dyslexia, or autism.
Fish consumption higher than twice a week.
Use of fish oil supplements
Seafood allergy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45803.096.13 |
| Other | NTR15155, maar dit is enkele dagen geleden gebeurd en het officiele nummer moet nog worden toegekend |