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

NCT02462746 | Completed Phase 1 DMC

• 1 other identifier: 100-2014
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Postpartum; Dietary Supplements; Breastfeeding Women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• plasma cysteine levels

  These are sampled over 10 hours before and after administration of cysteine

Study Arms (3)

No supplement

NO INTERVENTION

This group subjects will not receive the supplement

1.5 gram of l-cysteine

ACTIVE COMPARATOR

Intervention: single dose of 1.5 g L-Cysteine.

Dietary Supplement: L-Cysteine

3 grams of l-cysteine

ACTIVE COMPARATOR

Intervention: single dose of 3.0 g L-Cysteine.

Dietary Supplement: L-Cysteine

Interventions

L-Cysteine DIETARY_SUPPLEMENT

The trade name is New Root Herbal Inc.

Also known as: Cysteine

1.5 gram of l-cysteine; 3 grams of l-cysteine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Research Imaging Centre, Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

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

MeSH Terms

Interventions

Cysteine

Intervention Hierarchy (Ancestors)

Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Sulfhydryl Compounds; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Jeff Meyer, MD,PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Canada Research Chair

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 4, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: September 8, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)