Stress, PsychologicalTYRO-STRESSNCT04518254
Contribution of L-Tyrosine to Human Decision Making in Stressful Situations
A study testing Blood collection, L-Tyrosine 500 Mg and Cognitive tasks in people with Stress, Psychological, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Blood collection, L-Tyrosine 500 Mg and Cognitive tasks
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2021to 7 Apr 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- From 18 to 65 years of age
Who cannot join
- Tyrosine intake within the previous 15 days
- History of neurological or psychiatric disorder
- History of nephrological or endocrine disorder or liver failure
- Hereditary tyrosinemia
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, 91223
About this study
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.
- Conditions
- Stress, Psychological
- Being tested
- Blood collection, L-Tyrosine 500 Mg, Placebo, Cognitive tasks, Stress exposure
- Keywords
- L-tyrosine
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionBiological
A blood sample will be collected before and after treatment administration
L-Tyrosine 500 MgDrug
The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route
PlaceboDrug
The participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route
Cognitive tasksBehavioural
The participants will perform cognitive decision-making tasks: Simon task and masking task after treatment administration
Stress exposureOther
Unpleasant but not painful skin stimulations will be administered to the participants at variable intervals on the left leg during the cognitive tasks
Anxiety scaleBehavioural
Spielberger's State Trait Anxiety Inventory (STAI) will be filled by the participants before and after cognitive tasks
Electromyography (EMG)Device
Electromyography measurements will be performed during cognitive tasks.
Electroencephalography (EEG)Device
Electroencephalography measurements will be performed during cognitive tasks.
| Study group | Role | What they receive |
|---|---|---|
| Tyrosine - Test | Experimental | 4 similar visits (day 0, day 3, day 6, day 9): Administration of L-tyrosine No stress exposure Receives: Biological: Blood collection; Drug: L-Tyrosine 500 Mg; Behavioral: Cognitive tasks; Behavioral: Anxiety scale; Device: Electromyography (EMG); Device: Electroencephalography (EEG) |
| Tyrosine - Stress | Experimental | 4 similar visits (day 0, day 3, day 6, day 9): Administration of L-tyrosine Stress exposure Receives: Biological: Blood collection; Drug: L-Tyrosine 500 Mg; Behavioral: Cognitive tasks; Other: Stress exposure; Behavioral: Anxiety scale; Device: Electromyography (EMG); Device: Electroencephalography (EEG) |
| Placebo - Test | Experimental | 4 similar visits (day 0, day 3, day 6, day 9): Administration of Placebo No stress exposure Receives: Biological: Blood collection; Drug: Placebo; Behavioral: Cognitive tasks; Behavioral: Anxiety scale; Device: Electromyography (EMG); Device: Electroencephalography (EEG) |
| Placebo - Stress | Experimental | 4 similar visits (day 0, day 3, day 6, day 9): Administration of Placebo Stress exposure Receives: Biological: Blood collection; Drug: Placebo; Behavioral: Cognitive tasks; Other: Stress exposure; Behavioral: Anxiety scale; Device: Electromyography (EMG); Device: Electroencephalography (EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction Time
Reaction Time at the cognitive tasks
Measured: At day 9 (9 days after enrollment)
Number of incorrect responses
Number of incorrect responses at the cognitive tasks
Measured: At day 9
Secondary outcomes (4)
Error negativity
Error negativity on motor evoked potentials (measured by EMG)
Measured: At day 9
Correlation coefficient between anxiety level and tyrosinemia
Correlation coefficient between anxiety level (measured by anxiety scale) and tyrosinemia (measured in blood sample)
Measured: At day 9
Correlation coefficient between anxiety level and plasma tyrosine
Correlation coefficient between anxiety level (measured by anxiety scale) and plasma tyrosine (measured in blood sample)
Measured: At day 9
Correlation coefficient between cortisolaemia and melatoninaemia
Correlation coefficient between cortisolaemia and melatoninaemia (measured in blood sample)
Measured: At day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start18 Nov 2021
- Primary completion7 Apr 2022
- Study completion7 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies 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
- Crossover
- Model description
- The study is composed of 4 arms: 1. Tyrosine treatment without stress exposure 2. Tyrosine treatment with stress exposure 3. Placebo treatment without stress exposure 4. Placebo treatment with stress exposure Every participants will participate in the 4 arms in a random order.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518254
- Sponsor's protocol ID
- 2018PPRC25
- Other IDs
- 2019-A03194-53
- Acronym
- TYRO-STRESS
- Status last verified
- Nov 2022
- First submitted
- 15 Aug 2020
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of L-Tyrosine to Human Decision Making in Stressful Situations
- ClinicalTrials.gov ID
- NCT04518254
- Acronym / sponsor ID
- TYRO-STRESS / 2018PPRC25
- Conditions
- Stress, Psychological
- Keywords
- L-tyrosine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 7 Apr 2022 (actual)
- First posted
- 19 Aug 2020 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The study is composed of 4 arms: 1. Tyrosine treatment without stress exposure 2. Tyrosine treatment with stress exposure 3. Placebo treatment without stress exposure 4. Placebo treatment with stress exposure Every participants will participate in the 4 arms in a random order.
| Arm | Type | Receives |
|---|---|---|
| Tyrosine - Test | Experimental | Biological: Blood collection, Drug: L-Tyrosine 500 Mg, Behavioral: Cognitive tasks, Behavioral: Anxiety scale, Device: Electromyography (EMG), Device: Electroencephalography (EEG)4 similar visits (day 0, day 3, day 6, day 9): Administration of L-tyrosine No stress exposure |
| Tyrosine - Stress | Experimental | Biological: Blood collection, Drug: L-Tyrosine 500 Mg, Behavioral: Cognitive tasks, Other: Stress exposure, Behavioral: Anxiety scale, Device: Electromyography (EMG), Device: Electroencephalography (EEG)4 similar visits (day 0, day 3, day 6, day 9): Administration of L-tyrosine Stress exposure |
| Placebo - Test | Experimental | Biological: Blood collection, Drug: Placebo, Behavioral: Cognitive tasks, Behavioral: Anxiety scale, Device: Electromyography (EMG), Device: Electroencephalography (EEG)4 similar visits (day 0, day 3, day 6, day 9): Administration of Placebo No stress exposure |
| Placebo - Stress | Experimental | Biological: Blood collection, Drug: Placebo, Behavioral: Cognitive tasks, Other: Stress exposure, Behavioral: Anxiety scale, Device: Electromyography (EMG), Device: Electroencephalography (EEG)4 similar visits (day 0, day 3, day 6, day 9): Administration of Placebo Stress exposure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- From 18 to 65 years of age
Key exclusion criteria (4 listed)
- Tyrosine intake within the previous 15 days
- History of neurological or psychiatric disorder
- History of nephrological or endocrine disorder or liver failure
- Hereditary tyrosinemia
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 |
|---|---|---|
| Blood collectionA blood sample will be collected before and after treatment administration | Biological | Placebo - Stress, Placebo - Test, Tyrosine - Stress, Tyrosine - Test |
| L-Tyrosine 500 MgThe participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route | Drug | Tyrosine - Stress, Tyrosine - Test |
| PlaceboThe participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route | Drug | Placebo - Stress, Placebo - Test |
| Cognitive tasksThe participants will perform cognitive decision-making tasks: Simon task and masking task after treatment administration | Behavioural | Placebo - Stress, Placebo - Test, Tyrosine - Stress, Tyrosine - Test |
| Stress exposureUnpleasant but not painful skin stimulations will be administered to the participants at variable intervals on the left leg during the cognitive tasks | Other | Placebo - Stress, Tyrosine - Stress |
| Anxiety scaleSpielberger's State Trait Anxiety Inventory (STAI) will be filled by the participants before and after cognitive tasks | Behavioural | Placebo - Stress, Placebo - Test, Tyrosine - Stress, Tyrosine - Test |
| Electromyography (EMG)Electromyography measurements will be performed during cognitive tasks. | Device | Placebo - Stress, Placebo - Test, Tyrosine - Stress, Tyrosine - Test |
| Electroencephalography (EEG)Electroencephalography measurements will be performed during cognitive tasks. | Device | Placebo - Stress, Placebo - Test, Tyrosine - Stress, Tyrosine - Test |
Primary outcome
Reaction Time
Time frame: At day 9 (9 days after enrollment)
Reaction Time at the cognitive tasks
Number of incorrect responses
Time frame: At day 9
Number of incorrect responses at the cognitive tasks
4 secondary outcomes
Error negativity
Time frame: At day 9
Correlation coefficient between anxiety level and tyrosinemia
Time frame: At day 9
Correlation coefficient between anxiety level and plasma tyrosine
Time frame: At day 9
Correlation coefficient between cortisolaemia and melatoninaemia
Time frame: At day 9
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 25 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood collection, L-Tyrosine 500 Mg and Cognitive tasks in people with Stress, Psychological, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
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 4 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 25 Nov 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 France. 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. 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?
Reaction Time (time frame: At day 9 (9 days after enrollment)). 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?
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 25 Nov 2022.