HealthyPhase 1NCT02462746
The Effect of Cysteine, Tryptophan and Tyrosine Supplements on Breast Milk
A Phase 1 study testing L-Cysteine in people with Healthy, run by Centre for Addiction and Mental Health at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- L-Cysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to Apr 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Research Imaging Centre, Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8
About this study
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.
Read the 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).
- Conditions
- Healthy
- Being tested
- L-Cysteine
- Keywords
- Postpartum, Dietary Supplements, Breastfeeding Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CysteineDietary supplement
Also called Cysteine
The trade name is New Root Herbal Inc.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: L-Cysteine |
| 3 grams of l-cysteine | Active comparator | Intervention: single dose of 3.0 g L-Cysteine. Receives: Dietary Supplement: L-Cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 the acute changes in plasma cysteine levels over 10 hours
Measured: These are sampled over 10 hours before and after administration of cysteine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff Meyer, Centre for Addiction and Mental Health
- Investigators
- Jeff Meyer, MD,PhD, Principal investigator, Centre for Addiction and Mental Health, Research Imaging Centre, Toronto, Ontario, Canada M5T 1R8
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462746
- Sponsor's protocol ID
- 100-2014
- Status last verified
- Sep 2016
- First submitted
- 2 Jun 2015
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cysteine, Tryptophan and Tyrosine Supplements on Breast Milk
- ClinicalTrials.gov ID
- NCT02462746
- Acronym / sponsor ID
- 100-2014
- Conditions
- Healthy
- Keywords
- Postpartum, Dietary Supplements, Breastfeeding Women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No supplement | No intervention | –This group subjects will not receive the supplement |
| 1.5 gram of l-cysteine | Active comparator | Dietary Supplement: L-CysteineIntervention: single dose of 1.5 g L-Cysteine. |
| 3 grams of l-cysteine | Active comparator | Dietary Supplement: L-CysteineIntervention: single dose of 3.0 g L-Cysteine. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-CysteineAlso: CysteineThe trade name is New Root Herbal Inc. | Dietary supplement | 1.5 gram of l-cysteine, 3 grams of l-cysteine |
Primary outcome
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.
1 secondary outcome
plasma cysteine levels
Time frame: These are sampled over 10 hours before and after administration of cysteine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Meyer, MD,PhD principal investigator
Centre for Addiction and Mental Health, Research Imaging Centre, Toronto, Ontario, Canada M5T 1R8
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L-Cysteine in people with Healthy, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast milk cysteine levels (time frame: The main protocol occurs of 10 hours of time when the pharmacokinetics of the amino acid are measured.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.