Contribution of L-Tyrosine to Human Decision Making in Stressful Situations
TYRO-STRESS
2 other identifiers
interventional
17
1 country
1
Brief Summary
L-tyrosine is a chemical precursor of dopamine. Under specific conditions, tyrosine administration can increase brain dopamine levels and therefore several studies have explored whether tyrosine supplementation can have a beneficial effect on cognitive and behavioural performance that is dependent on dopaminergic function. However, the effects of tyrosine supplementation are mixed: some studies show positive effects while others do not. Stress leads to an increase in dopaminergic activity and turnover in the brain, resulting in a decrease in brain dopamine levels. We propose to study the contribution of tyrosine to decision making and more particularly to the processes of response selection (mediated by the prefrontal cortex and under the influence of the dopaminergic system) in stressful situations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2020
CompletedFirst Posted
Study publicly available on registry
August 19, 2020
CompletedStudy Start
First participant enrolled
November 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 7, 2022
CompletedNovember 25, 2022
November 1, 2022
5 months
August 15, 2020
November 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reaction Time
Reaction Time at the cognitive tasks
At day 9 (9 days after enrollment)
Number of incorrect responses
Number of incorrect responses at the cognitive tasks
At day 9
Secondary Outcomes (4)
Error negativity
At day 9
Correlation coefficient between anxiety level and tyrosinemia
At day 9
Correlation coefficient between anxiety level and plasma tyrosine
At day 9
Correlation coefficient between cortisolaemia and melatoninaemia
At day 9
Study Arms (4)
Tyrosine - Test
EXPERIMENTAL4 similar visits (day 0, day 3, day 6, day 9): Administration of L-tyrosine No stress exposure
Tyrosine - Stress
EXPERIMENTAL4 similar visits (day 0, day 3, day 6, day 9): Administration of L-tyrosine Stress exposure
Placebo - Test
EXPERIMENTAL4 similar visits (day 0, day 3, day 6, day 9): Administration of Placebo No stress exposure
Placebo - Stress
EXPERIMENTAL4 similar visits (day 0, day 3, day 6, day 9): Administration of Placebo Stress exposure
Interventions
A blood sample will be collected before and after treatment administration
The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route
The participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route
The participants will perform cognitive decision-making tasks: Simon task and masking task after treatment administration
Unpleasant but not painful skin stimulations will be administered to the participants at variable intervals on the left leg during the cognitive tasks
Spielberger's State Trait Anxiety Inventory (STAI) will be filled by the participants before and after cognitive tasks
Electromyography measurements will be performed during cognitive tasks.
Electroencephalography measurements will be performed during cognitive tasks.
Eligibility Criteria
You may qualify if:
- From 18 to 65 years of age
You may not qualify if:
- Tyrosine intake within the previous 15 days
- History of neurological or psychiatric disorder
- History of nephrological or endocrine disorder or liver failure
- Hereditary tyrosinemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, 91223, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The pharmacist, carrying out the packaging and labelling of the treatment units, will ensure the blinding. Neither the participant nor the investigator will know what treatment is being administered.
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2020
First Posted
August 19, 2020
Study Start
November 18, 2021
Primary Completion
April 7, 2022
Study Completion
April 7, 2022
Last Updated
November 25, 2022
Record last verified: 2022-11