Contribution of L-Tyrosine to Human Decision Making in Stressful Situations

NCT ID: NCT04518254

Last Updated: 2022-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-18

Study Completion Date

2022-04-07

Brief Summary

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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.

Detailed Description

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Conditions

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Stress, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Tyrosine - Test

4 similar visits (day 0, day 3, day 6, day 9): Administration of L-tyrosine No stress exposure

Group Type EXPERIMENTAL

Blood collection

Intervention Type BIOLOGICAL

A blood sample will be collected before and after treatment administration

L-Tyrosine 500 Mg

Intervention Type DRUG

The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route

Cognitive tasks

Intervention Type BEHAVIORAL

The participants will perform cognitive decision-making tasks: Simon task and masking task after treatment administration

Anxiety scale

Intervention Type BEHAVIORAL

Spielberger's State Trait Anxiety Inventory (STAI) will be filled by the participants before and after cognitive tasks

Electromyography (EMG)

Intervention Type DEVICE

Electromyography measurements will be performed during cognitive tasks.

Electroencephalography (EEG)

Intervention Type DEVICE

Electroencephalography measurements will be performed during cognitive tasks.

Tyrosine - Stress

4 similar visits (day 0, day 3, day 6, day 9): Administration of L-tyrosine Stress exposure

Group Type EXPERIMENTAL

Blood collection

Intervention Type BIOLOGICAL

A blood sample will be collected before and after treatment administration

L-Tyrosine 500 Mg

Intervention Type DRUG

The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route

Cognitive tasks

Intervention Type BEHAVIORAL

The participants will perform cognitive decision-making tasks: Simon task and masking task after treatment administration

Stress exposure

Intervention Type OTHER

Unpleasant but not painful skin stimulations will be administered to the participants at variable intervals on the left leg during the cognitive tasks

Anxiety scale

Intervention Type BEHAVIORAL

Spielberger's State Trait Anxiety Inventory (STAI) will be filled by the participants before and after cognitive tasks

Electromyography (EMG)

Intervention Type DEVICE

Electromyography measurements will be performed during cognitive tasks.

Electroencephalography (EEG)

Intervention Type DEVICE

Electroencephalography measurements will be performed during cognitive tasks.

Placebo - Test

4 similar visits (day 0, day 3, day 6, day 9): Administration of Placebo No stress exposure

Group Type EXPERIMENTAL

Blood collection

Intervention Type BIOLOGICAL

A blood sample will be collected before and after treatment administration

Placebo

Intervention Type DRUG

The participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route

Cognitive tasks

Intervention Type BEHAVIORAL

The participants will perform cognitive decision-making tasks: Simon task and masking task after treatment administration

Anxiety scale

Intervention Type BEHAVIORAL

Spielberger's State Trait Anxiety Inventory (STAI) will be filled by the participants before and after cognitive tasks

Electromyography (EMG)

Intervention Type DEVICE

Electromyography measurements will be performed during cognitive tasks.

Electroencephalography (EEG)

Intervention Type DEVICE

Electroencephalography measurements will be performed during cognitive tasks.

Placebo - Stress

4 similar visits (day 0, day 3, day 6, day 9): Administration of Placebo Stress exposure

Group Type EXPERIMENTAL

Blood collection

Intervention Type BIOLOGICAL

A blood sample will be collected before and after treatment administration

Placebo

Intervention Type DRUG

The participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route

Cognitive tasks

Intervention Type BEHAVIORAL

The participants will perform cognitive decision-making tasks: Simon task and masking task after treatment administration

Stress exposure

Intervention Type OTHER

Unpleasant but not painful skin stimulations will be administered to the participants at variable intervals on the left leg during the cognitive tasks

Anxiety scale

Intervention Type BEHAVIORAL

Spielberger's State Trait Anxiety Inventory (STAI) will be filled by the participants before and after cognitive tasks

Electromyography (EMG)

Intervention Type DEVICE

Electromyography measurements will be performed during cognitive tasks.

Electroencephalography (EEG)

Intervention Type DEVICE

Electroencephalography measurements will be performed during cognitive tasks.

Interventions

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Blood collection

A blood sample will be collected before and after treatment administration

Intervention Type BIOLOGICAL

L-Tyrosine 500 Mg

The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route

Intervention Type DRUG

Placebo

The participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route

Intervention Type DRUG

Cognitive tasks

The participants will perform cognitive decision-making tasks: Simon task and masking task after treatment administration

Intervention Type BEHAVIORAL

Stress exposure

Unpleasant but not painful skin stimulations will be administered to the participants at variable intervals on the left leg during the cognitive tasks

Intervention Type OTHER

Anxiety scale

Spielberger's State Trait Anxiety Inventory (STAI) will be filled by the participants before and after cognitive tasks

Intervention Type BEHAVIORAL

Electromyography (EMG)

Electromyography measurements will be performed during cognitive tasks.

Intervention Type DEVICE

Electroencephalography (EEG)

Electroencephalography measurements will be performed during cognitive tasks.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* From 18 to 65 years of age

Exclusion Criteria

* Tyrosine intake within the previous 15 days
* History of neurological or psychiatric disorder
* History of nephrological or endocrine disorder or liver failure
* Hereditary tyrosinemia
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Direction Centrale du Service de Santé des Armées

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut de Recherche Biomédicale des Armées

Brétigny-sur-Orge, , France

Site Status

Countries

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France

Other Identifiers

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2019-A03194-53

Identifier Type: OTHER

Identifier Source: secondary_id

2018PPRC25

Identifier Type: -

Identifier Source: org_study_id

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