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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: L-Cysteine

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).

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 1R8
      • Research Imaging Centre, Centre for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: Cysteine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: June 2, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 4, 2015

Study Record Updates

• Last Update Posted (Estimate): September 8, 2016
• Last Update Submitted That Met QC Criteria: September 7, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Postpartum; Dietary Supplements; Breastfeeding Women
• Other Study ID Numbers: 100-2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No