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The Effect of Cysteine, Tryptophan and Tyrosine Supplements on Breast Milk

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ClinicalTrials.gov Identifier: NCT02462746
Recruitment Status : Completed
First Posted : June 4, 2015
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
Jeff Meyer, Centre for Addiction and Mental Health

Brief Summary:
The purpose of this project is to study the effect of dietary supplementation with a natural health product (NHP) with a focus on its effects on its levels in breast milk.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: L-Cysteine Phase 1

Detailed Description:

The effect of oral cysteine on its levels in breast milk and plasma will be measured in breast feeding mothers.

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Cysteine, Tryptophan and Tyrosine Supplements on Breast Milk
Study Start Date : March 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No supplement
This group subjects will not receive the supplement
Active Comparator: 1.5 gram of l-cysteine
Intervention: single dose of 1.5 g L-Cysteine.
Dietary Supplement: L-Cysteine
The trade name is New Root Herbal Inc.
Other Name: Cysteine

Active Comparator: 3 grams of l-cysteine
Intervention: single dose of 3.0 g L-Cysteine.
Dietary Supplement: L-Cysteine
The trade name is New Root Herbal Inc.
Other Name: Cysteine




Primary Outcome Measures :
  1. Breast milk cysteine levels [ Time Frame: The main protocol occurs of 10 hours of time when the pharmacokinetics of the amino acid are measured. ]

    measurement of amino acid before and after acute administration over a 10 hour period

    • The first visit would be the screening visit, which the subjects will be evaluated for general health status through a standardized health questionnaire. A urine test will be done in order to screen for any drug use.
    • On the second visit, each subject would be tested for plasma levels of the amino acid during the day. In addition breast milk will be tested in order to examine the effect of these supplements on the amino acid contents of the breast milk at few time points on both days.


Secondary Outcome Measures :
  1. plasma cysteine levels [ Time Frame: These are sampled over 10 hours before and after administration of cysteine ]
    These are the acute changes in plasma cysteine levels over 10 hours



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects would be healthy mothers who are breastfeeding at the moment, but plan to stop at the time of study
  • 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 has taken any investigational medicinal product within 8 weeks prior to dosing
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462746


Locations
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Canada, Ontario
Research Imaging Centre, Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Jeff Meyer, MD,PhD Centre for Addiction and Mental Health, Research Imaging Centre, Toronto, Ontario, Canada M5T 1R8

Additional Information:
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Responsible Party: Jeff Meyer, Canada Research Chair, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT02462746     History of Changes
Other Study ID Numbers: 100-2014
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jeff Meyer, Centre for Addiction and Mental Health:
Postpartum
Dietary Supplements
Breastfeeding Women

Additional relevant MeSH terms:
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Tryptophan
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs