Ulcerative ColitisNCT02423460
Threonine Requirement in IBD Adults and Healthy Adult Controls
A study testing Threonine in people with Ulcerative Colitis and Crohn's Disease, run by Société des Produits Nestlé (SPN) at 1 site in Canada.
Trial summary
The daily requirement of threonine, an essential amino acid, will be evaluated in healthy adult males and in adult males with Crohn's Disease or ulcerative colitis using the indicator amino acid oxidation (IAAO) method. Participants will consume specially formulated diets with varying levels of threonine. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease, Healthy
- What is being tested?
- Threonine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to 23 Sep 2018
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male age 18 - 40 years of age
- Having obtained his (or his legal representative's) written informed consent.
- Normally nourished and without any inter-current illness.
- Absence of an active inflammatory process in the past month.
- Male age 18 - 40 years of age
- Having obtained his (or his legal representative's) Written Informed Consent.
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- For both conditions, stable disease state and not malnourished per the treating physician.
- CD: Harvey Bradshaw Index (HBI) ≤ 8, disease location: evidence of ileal and or colon inflammatory involvement, no known strictures
- UC: Mayo Score ≤ 7 (or Partial Mayo Score ≤5)
- No tube feeding - Subjects must be treated and followed by the Gastroenterology team at Mt. Sinai Hospital, Toronto.
Who cannot join
- Subject who cannot be expected to comply with the study procedures.
- Currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study.
- Uncontrolled inflammation which will likely require surgery or escalation of therapy in the next 4 weeks
- Concomitant treatment:corticosteroids > 20mg/day
- Subject who cannot be expected to comply with the study procedures. - Subjects not treated and followed by the Gastroenterology team at Mt. Sinai Hospital, Toronto
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Threonine Requirement in Healthy Adult Subjects and in Patients With Crohn's Disease and With Ulcerative Colitis Using the Indicator Amino Acid Oxidation (IAAO) Methodology
The daily requirement of threonine, an essential amino acid, will be evaluated in healthy adult males and in adult males with Crohn's Disease or ulcerative colitis using the indicator amino acid oxidation (IAAO) method. Participants will consume specially formulated diets with varying levels of threonine.
Read the detailed description
Threonine is an essential amino acid which must be obtained from the diet. It is a component of mucin. Mucin, in turn, is a key protein in the mucous membrane that protects the lining of the intestine.
Inflammatory bowel disease (IBD) is a group of inflammatory conditions that affect the colon and small intestine. IBD primarily includes ulcerative colitis (UC) and Crohn's disease (CD). In UC, the inflammation is usually in the colon whereas in CD inflammation may occur anywhere along the digestive tract. Studies in animals have shown that more threonine is used when there is inflammation in the intestine.
The threonine requirement in healthy participants and in IBD patients will be determined using the indicator amino acid oxidation method. The requirement derived in healthy participants will be compared to that derived in patients with IBD.
Each participant will take part in two x 3 day study periods. The first two days are called adaptation days where the subjects will consume a liquid diet specially designed for him. The diet will be consumed at home. It contains all vitamins, minerals, protein and all other nutrients required. On the third day, the participant will come to the Hospital for Sick Children in Toronto. Subjects will consume hourly meals for a total of 8 meals and a stable isotope 13C-phenylalanine. Breath and urine samples will be collected to measure the oxidation of phenylalanine from which the threonine requirement will be determined.
- Conditions
- Ulcerative Colitis, Crohn's Disease, Healthy
- Being tested
- Threonine
- Keywords
- Ulcerative Colitis, Healthy Controls, Crohn's Disease
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThreonineOther
Also called amino acid
Threonine will be fed at various intake levels ranging from high to low in order to determine its requirement in healthy males and in patients with Crohn's disease and Ulcerative colitis.
| Study group | Role | What they receive |
|---|---|---|
| Threonine requirement | Experimental | The threonine requirement in healthy male subjects and in patients with Crohn's disease and Ulcerative colitis Receives: Other: Threonine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Threonine requirement in those with Crohn's Disease, ulcerative colitis and in healthy controls determined using the indicator amino acid oxidation method
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startMay 2015
- Primary completion17 Sep 2018
- Study completion23 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Hospital for Sick Children, Mount Sinai Hospital, Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423460
- Sponsor's protocol ID
- 1000046356
- Status last verified
- Nov 2018
- First submitted
- 12 Apr 2015
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Threonine Requirement in Healthy Adult Subjects and in Patients With Crohn's Disease and With Ulcerative Colitis Using the Indicator Amino Acid Oxidation (IAAO) Methodology
- ClinicalTrials.gov ID
- NCT02423460
- Acronym / sponsor ID
- 1000046356
- Conditions
- Ulcerative Colitis, Crohn's Disease, Healthy
- Keywords
- Ulcerative Colitis, Healthy Controls, Crohn's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- The Hospital for Sick Children, Mount Sinai Hospital, Canada
- Study start
- May 2015
- Primary completion
- 17 Sep 2018 (actual)
- Study completion
- 23 Sep 2018 (actual)
- First posted
- 22 Apr 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 daily requirement of threonine, an essential amino acid, will be evaluated in healthy adult males and in adult males with Crohn's Disease or ulcerative colitis using the indicator amino acid oxidation (IAAO) method. Participants will consume specially formulated diets with varying levels of threonine.
Detailed description
Threonine is an essential amino acid which must be obtained from the diet. It is a component of mucin. Mucin, in turn, is a key protein in the mucous membrane that protects the lining of the intestine.
Inflammatory bowel disease (IBD) is a group of inflammatory conditions that affect the colon and small intestine. IBD primarily includes ulcerative colitis (UC) and Crohn's disease (CD). In UC, the inflammation is usually in the colon whereas in CD inflammation may occur anywhere along the digestive tract. Studies in animals have shown that more threonine is used when there is inflammation in the intestine.
The threonine requirement in healthy participants and in IBD patients will be determined using the indicator amino acid oxidation method. The requirement derived in healthy participants will be compared to that derived in patients with IBD.
Each participant will take part in two x 3 day study periods. The first two days are called adaptation days where the subjects will consume a liquid diet specially designed for him. The diet will be consumed at home. It contains all vitamins, minerals, protein and all other nutrients required. On the third day, the participant will come to the Hospital for Sick Children in Toronto. Subjects will consume hourly meals for a total of 8 meals and a stable isotope 13C-phenylalanine. Breath and urine samples will be collected to measure the oxidation of phenylalanine from which the threonine requirement will be determined.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Threonine requirement | Experimental | Other: ThreonineThe threonine requirement in healthy male subjects and in patients with Crohn's disease and Ulcerative colitis |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male age 18 - 40 years of age
- Having obtained his (or his legal representative's) written informed consent.
- Normally nourished and without any inter-current illness.
- Absence of an active inflammatory process in the past month.
- Male age 18 - 40 years of age
Key exclusion criteria (5 listed)
- Subject who cannot be expected to comply with the study procedures.
- Currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study.
- Uncontrolled inflammation which will likely require surgery or escalation of therapy in the next 4 weeks
- Concomitant treatment:corticosteroids > 20mg/day
- Subject who cannot be expected to comply with the study procedures. - Subjects not treated and followed by the Gastroenterology team at Mt. Sinai Hospital, Toronto
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 |
|---|---|---|
| ThreonineAlso: amino acidThreonine will be fed at various intake levels ranging from high to low in order to determine its requirement in healthy males and in patients with Crohn's disease and Ulcerative colitis. | Other | Threonine requirement |
Primary outcome
Threonine requirement in those with Crohn's Disease, ulcerative colitis and in healthy controls determined using the indicator amino acid oxidation method
Time frame: 2 years
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 6 Nov 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threonine in people with Ulcerative Colitis and Crohn's Disease, run by Société des Produits Nestlé (SPN) 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 10 inclusion and 5 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 6 Nov 2018. 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?
Threonine requirement in those with Crohn's Disease, ulcerative colitis and in healthy controls determined using the indicator amino acid oxidation method (time frame: 2 years). 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 6 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.