The Effect of Cysteine, Tryptophan and Tyrosine Supplements on Breast Milk
NCT ID: NCT02462746
Last Updated: 2016-09-08
Study Results
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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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2015-03-31
2016-04-30
Brief Summary
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Detailed Description
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The investigators will not be studying tryptophan and tyrosine in this study. The title is an overview title left over from other past studies (but the investigators are only assessing cysteine at this time).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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No supplement
This group subjects will not receive the supplement
No interventions assigned to this group
1.5 gram of l-cysteine
Intervention: single dose of 1.5 g L-Cysteine.
L-Cysteine
The trade name is New Root Herbal Inc.
3 grams of l-cysteine
Intervention: single dose of 3.0 g L-Cysteine.
L-Cysteine
The trade name is New Root Herbal Inc.
Interventions
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L-Cysteine
The trade name is New Root Herbal Inc.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The subject, as reported, should be in a good health
* The subject is not taking any medication
* The subject is not taking any investigational medicinal product within 8 weeks prior to dosing
* The subject does not have any known hypersensitivity to components in the proposed treatment
* The subject does not have a history of severe drug allergy or drug hypersensitivity
Other general medical requirements for inclusion:
* Age 18 to 45
* BMI 19 to 40 (kg/m2)
* Resting pulse between 45 and 100 bpm
* Systolic blood pressure between 91 and 139 mmHg (inclusive)
* Diastolic blood pressure between 51 and 90 mmHg (inclusive)
* Orthostatic blood pressure change \<20 mmHg (based on the difference between supine and standing (1 minute) systolic blood pressure)
* The subject is in good health based on their report and answer to general health questionnaire
Exclusion Criteria
* The subject is pregnant (based upon urine pregnancy test at time of screening and day of supplement intake)
* The subject has known hypersensitivity to components in the proposed treatment or to related compounds
* The subject has a history of severe drug allergy or drug hypersensitivity involving an anaphylactic reaction i.e. shortness of breath and/or reduced blood pressure
* Subjects who are smoking more than one package of cigarette per day will be excluded from the study
* The subject decides to breastfeed the infant on the study day
18 Years
45 Years
FEMALE
Yes
Sponsors
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Centre for Addiction and Mental Health
OTHER
Responsible Party
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Jeff Meyer
Canada Research Chair
Principal Investigators
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Jeff Meyer, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Addiction and Mental Health, Research Imaging Centre, Toronto, Ontario, Canada M5T 1R8
Locations
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Research Imaging Centre, Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
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Related Links
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Information about research at the Centre for Addiction and Mental Health
Other Identifiers
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100-2014
Identifier Type: -
Identifier Source: org_study_id
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