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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462746
• Other study ID #: 100-2014
• Status: Completed
• Phase: Phase 1
• First received: June 2, 2015
• Last updated: September 7, 2016
• Start date: March 2015
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• L-Cysteine
The trade name is New Root Herbal Inc.

Locations

Country	Name	City	State
Canada	Research Imaging Centre, Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast milk cysteine levels	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.	The main protocol occurs of 10 hours of time when the pharmacokinetics of the amino acid are measured.	No
Secondary	plasma cysteine levels	These are the acute changes in plasma cysteine levels over 10 hours	These are sampled over 10 hours before and after administration of cysteine	No

External Links

•   Information about research at the Centre for Addiction and Mental Health