NCT04518254

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 18, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2022

Completed
Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

August 15, 2020

Last Update Submit

November 23, 2022

Conditions

Keywords

L-tyrosine

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

EXPERIMENTAL

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

Biological: Blood collectionDrug: L-Tyrosine 500 MgBehavioral: Cognitive tasksBehavioral: Anxiety scaleDevice: 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

Biological: Blood collectionDrug: L-Tyrosine 500 MgBehavioral: Cognitive tasksOther: Stress exposureBehavioral: Anxiety scaleDevice: 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

Biological: Blood collectionDrug: PlaceboBehavioral: Cognitive tasksBehavioral: Anxiety scaleDevice: Electromyography (EMG)Device: Electroencephalography (EEG)

Placebo - Stress

EXPERIMENTAL

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

Biological: Blood collectionDrug: PlaceboBehavioral: Cognitive tasksOther: Stress exposureBehavioral: Anxiety scaleDevice: Electromyography (EMG)Device: Electroencephalography (EEG)

Interventions

A blood sample will be collected before and after treatment administration

Placebo - StressPlacebo - TestTyrosine - StressTyrosine - Test

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

Tyrosine - StressTyrosine - Test

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

Placebo - StressPlacebo - Test
Cognitive tasksBEHAVIORAL

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

Placebo - StressPlacebo - TestTyrosine - StressTyrosine - Test

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

Placebo - StressTyrosine - Stress
Anxiety scaleBEHAVIORAL

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

Placebo - StressPlacebo - TestTyrosine - StressTyrosine - Test

Electromyography measurements will be performed during cognitive tasks.

Placebo - StressPlacebo - TestTyrosine - StressTyrosine - Test

Electroencephalography measurements will be performed during cognitive tasks.

Placebo - StressPlacebo - TestTyrosine - StressTyrosine - Test

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Blood Specimen CollectionTyrosineElectromyographyElectroencephalography

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsElectrodiagnosisMyographyDiagnostic Techniques, Neurological

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
Model Details: 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.
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

Locations