Threonine Requirements in ChildrenNCT02660892
Determination of Threonine Requirements in Healthy School-aged Children
A study testing Protein intake in people with Threonine Requirements in Children, run by University of British Columbia at 1 site in Canada.
Trial summary
Threonine is an indispensable amino acid (nutrient containing nitrogen), which cannot be made in the body and must be consumed from food. Amino acids are the building blocks of protein in your body, and need to be eaten in required amounts to maintain health and growth. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Threonine Requirements in Children
- What is being tested?
- Protein intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 26 May 2016to 1 Oct 2017
- Phase
- Interventional
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between 6 and 10 Y
- No history of chronic disease or metabolic disorders
- No food allergies
- No recent illness or antibiotic consumption
- Children with a normal, healthy, body weight (between 3rd and 85th percentiles for their age group for weight) (Dietitians of Canada, 2015)
Who cannot join
- Children under 6 years' old
- Children over 10 years' old
- Children with a history of disease or metabolic disorders
- Children with any food allergies
- Children taking prescription medication
- Children with a history of being underweight, overweight, or obese (Dietitians of Canada, 2015; Onis et al., 2007)
- o Below 3rd percentile for weight, Above 85th percentile for weight
- Female children who have commenced menstruation
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's Hospital Research Institute
Vancouver, British Columbia, V5Z4H4
About this study
Official title: Determination of Threonine Requirements and the Metabolic Availability of Threonine From Food Sources in Healthy School-aged Children
Threonine is an indispensable amino acid (nutrient containing nitrogen), which cannot be made in the body and must be consumed from food. Amino acids are the building blocks of protein in your body, and need to be eaten in required amounts to maintain health and growth. Deficiency in threonine can affect small intestine growth due to its structural importance in the intestinal protein mucin. While threonine is found in many foods, deficiency can occur in developing countries where nutrition is primarily plant based, and low in available protein.
Therefore, the purpose of this study is to determine the requirement of the indispensable amino acid Threonine, in school-aged children (6-10y). Secondly, we wish to determine the availability of threonine from three test proteins (soy, green pea, casein).
Read the detailed description
The threonine intake requirement for children are based on factorial calculations. In the current study we will use a new and modern technique, the indicator amino acid oxidation technique (IAAO), to determine threonine requirements in children.
This technique is a newer technique which involves the consumption of protein shakes composed of specific amounts of threonine mixed with a stable isotope tracer. The oxidation of this isotope will be measured in urine and breath to determine a breakpoint (requirement) of threonine.
Determining the requirement for threonine, as well as the availability of threonine from various food products will help us to develop better food recommendations for children.
Research Method This study will be carried out in a repeated measures design. Participants will be recruited and screened for eligibility. Six participants will be brought in for 6 testing visits with reference amino acid, where they will be randomized to a level of threonine intake. A further 3 visits will be carried out during which participants will be randomized to a level of threonine consumption derived from alternative proteins (casein, soy, peas) which is at a threshold below the requirement for threonine to determine availability.
- Conditions
- Threonine Requirements in Children
- Being tested
- Protein intake
- Keywords
- IAAO, Threonine, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein intakeDietary supplement
Oral consumption of eight hourly experimental meals
- 4 tracer free experimental meals containing a mixture of free amino acids and calories from protein free flavoured liquid, protein free cookies and corn oil
- 4 isotopically labeled experimental meals.
| Study group | Role | What they receive |
|---|---|---|
| Protein Intake | Experimental | Threonine intake - Dietary supplement Receives: Dietary Supplement: Protein intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
13 Co2 production
Urine and breath samples will be collected during the study day, to measure the rate of oxidation of tracer phenylalanine in the expired breath, and flux enrichment in urine.
Measured: 8 hours (1 study day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study start26 May 2016
- Primary completion5 Jul 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Threonine Requirements in ChildrenStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajavel Elango, PhD, University of British Columbia
- Investigators
- Rajavel Elango, Ph.D, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660892
- Sponsor's protocol ID
- H15-02691
- Status last verified
- Feb 2020
- First submitted
- 18 Jan 2016
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Threonine Requirements and the Metabolic Availability of Threonine From Food Sources in Healthy School-aged Children
- ClinicalTrials.gov ID
- NCT02660892
- Acronym / sponsor ID
- H15-02691
- Conditions
- Threonine Requirements in Children
- Keywords
- IAAO, Threonine, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 26 May 2016 (actual)
- Primary completion
- 5 Jul 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 21 Jan 2016 (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.
Threonine is an indispensable amino acid (nutrient containing nitrogen), which cannot be made in the body and must be consumed from food. Amino acids are the building blocks of protein in your body, and need to be eaten in required amounts to maintain health and growth. Deficiency in threonine can affect small intestine growth due to its structural importance in the intestinal protein mucin. While threonine is found in many foods, deficiency can occur in developing countries where nutrition is primarily plant based, and low in available protein.
Therefore, the purpose of this study is to determine the requirement of the indispensable amino acid Threonine, in school-aged children (6-10y). Secondly, we wish to determine the availability of threonine from three test proteins (soy, green pea, casein).
Detailed description
The threonine intake requirement for children are based on factorial calculations. In the current study we will use a new and modern technique, the indicator amino acid oxidation technique (IAAO), to determine threonine requirements in children.
This technique is a newer technique which involves the consumption of protein shakes composed of specific amounts of threonine mixed with a stable isotope tracer. The oxidation of this isotope will be measured in urine and breath to determine a breakpoint (requirement) of threonine.
Determining the requirement for threonine, as well as the availability of threonine from various food products will help us to develop better food recommendations for children.
Research Method This study will be carried out in a repeated measures design. Participants will be recruited and screened for eligibility. Six participants will be brought in for 6 testing visits with reference amino acid, where they will be randomized to a level of threonine intake. A further 3 visits will be carried out during which participants will be randomized to a level of threonine consumption derived from alternative proteins (casein, soy, peas) which is at a threshold below the requirement for threonine to determine availability.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Protein Intake | Experimental | Dietary Supplement: Protein intakeThreonine intake - Dietary supplement |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children between 6 and 10 Y
- No history of chronic disease or metabolic disorders
- No food allergies
- No recent illness or antibiotic consumption
- Children with a normal, healthy, body weight (between 3rd and 85th percentiles for their age group for weight) (Dietitians of Canada, 2015)
Key exclusion criteria (8 listed)
- Children under 6 years' old
- Children over 10 years' old
- Children with a history of disease or metabolic disorders
- Children with any food allergies
- Children taking prescription medication
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 |
|---|---|---|
| Protein intakeOral consumption of eight hourly experimental meals * 4 tracer free experimental meals containing a mixture of free amino acids and calories from protein free flavoured liquid, protein free cookies and corn oil * 4 isotopically labeled experimental meals. | Dietary supplement | Protein Intake |
Primary outcome
13 Co2 production
Time frame: 8 hours (1 study day)
Urine and breath samples will be collected during the study day, to measure the rate of oxidation of tracer phenylalanine in the expired breath, and flux enrichment in urine.
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 11 Feb 2020.
- Individual participant dataSharing planned: No
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.
Rajavel Elango, Ph.D principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein intake in people with Threonine Requirements in Children, run by University of British Columbia 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 5 inclusion and 8 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 11 Feb 2020. 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.
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?
13 Co2 production (time frame: 8 hours (1 study day)). 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 11 Feb 2020.