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Contribution of L-Tyrosine to Human Decision Making in Stressful Situations (TYRO-STRESS)

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood collection
L-Tyrosine 500 Mg
Placebo
Cognitive tasks
Stress exposure
Anxiety scale
Electromyography (EMG)
Electroencephalography (EEG)
Sponsored by
Direction Centrale du Service de Santé des Armées
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress, Psychological focused on measuring L-tyrosine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institut de Recherche Biomédicale des Armées

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Tyrosine - Test

Tyrosine - Stress

Placebo - Test

Placebo - Stress

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Reaction Time
Reaction Time at the cognitive tasks
Number of incorrect responses
Number of incorrect responses at the cognitive tasks

Secondary Outcome Measures

Error negativity
Error negativity on motor evoked potentials (measured by EMG)
Correlation coefficient between anxiety level and tyrosinemia
Correlation coefficient between anxiety level (measured by anxiety scale) and tyrosinemia (measured in blood sample)
Correlation coefficient between anxiety level and plasma tyrosine
Correlation coefficient between anxiety level (measured by anxiety scale) and plasma tyrosine (measured in blood sample)
Correlation coefficient between cortisolaemia and melatoninaemia
Correlation coefficient between cortisolaemia and melatoninaemia (measured in blood sample)

Full Information

First Posted
August 15, 2020
Last Updated
November 23, 2022
Sponsor
Direction Centrale du Service de Santé des Armées
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1. Study Identification

Unique Protocol Identification Number
NCT04518254
Brief Title
Contribution of L-Tyrosine to Human Decision Making in Stressful Situations
Acronym
TYRO-STRESS
Official Title
Contribution of L-Tyrosine to Human Decision Making in Stressful Situations
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
April 7, 2022 (Actual)
Study Completion Date
April 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Direction Centrale du Service de Santé des Armées

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
L-tyrosine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The study is composed of 4 arms: Tyrosine treatment without stress exposure Tyrosine treatment with stress exposure Placebo treatment without stress exposure Placebo treatment with stress exposure Every participants will participate in the 4 arms in a random order.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tyrosine - Test
Arm Type
Experimental
Arm Description
4 similar visits (day 0, day 3, day 6, day 9): Administration of L-tyrosine No stress exposure
Arm Title
Tyrosine - Stress
Arm Type
Experimental
Arm Description
4 similar visits (day 0, day 3, day 6, day 9): Administration of L-tyrosine Stress exposure
Arm Title
Placebo - Test
Arm Type
Experimental
Arm Description
4 similar visits (day 0, day 3, day 6, day 9): Administration of Placebo No stress exposure
Arm Title
Placebo - Stress
Arm Type
Experimental
Arm Description
4 similar visits (day 0, day 3, day 6, day 9): Administration of Placebo Stress exposure
Intervention Type
Biological
Intervention Name(s)
Blood collection
Intervention Description
A blood sample will be collected before and after treatment administration
Intervention Type
Drug
Intervention Name(s)
L-Tyrosine 500 Mg
Intervention Description
The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route
Intervention Type
Behavioral
Intervention Name(s)
Cognitive tasks
Intervention Description
The participants will perform cognitive decision-making tasks: Simon task and masking task after treatment administration
Intervention Type
Other
Intervention Name(s)
Stress exposure
Intervention Description
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
Behavioral
Intervention Name(s)
Anxiety scale
Intervention Description
Spielberger's State Trait Anxiety Inventory (STAI) will be filled by the participants before and after cognitive tasks
Intervention Type
Device
Intervention Name(s)
Electromyography (EMG)
Intervention Description
Electromyography measurements will be performed during cognitive tasks.
Intervention Type
Device
Intervention Name(s)
Electroencephalography (EEG)
Intervention Description
Electroencephalography measurements will be performed during cognitive tasks.
Primary Outcome Measure Information:
Title
Reaction Time
Description
Reaction Time at the cognitive tasks
Time Frame
At day 9 (9 days after enrollment)
Title
Number of incorrect responses
Description
Number of incorrect responses at the cognitive tasks
Time Frame
At day 9
Secondary Outcome Measure Information:
Title
Error negativity
Description
Error negativity on motor evoked potentials (measured by EMG)
Time Frame
At day 9
Title
Correlation coefficient between anxiety level and tyrosinemia
Description
Correlation coefficient between anxiety level (measured by anxiety scale) and tyrosinemia (measured in blood sample)
Time Frame
At day 9
Title
Correlation coefficient between anxiety level and plasma tyrosine
Description
Correlation coefficient between anxiety level (measured by anxiety scale) and plasma tyrosine (measured in blood sample)
Time Frame
At day 9
Title
Correlation coefficient between cortisolaemia and melatoninaemia
Description
Correlation coefficient between cortisolaemia and melatoninaemia (measured in blood sample)
Time Frame
At day 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Institut de Recherche Biomédicale des Armées
City
Brétigny-sur-Orge
ZIP/Postal Code
91223
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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