Threonine Requirement in Adult Males With Crohn's Disease Using IAAO
Not applicable · Testing Dietary Intakes (Reference protein drinks (Scandishake, Solcarb, Beneprotein) and cookies) · 1 site · The Hospital for Sick Children
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Dietary Intakes (Reference protein drinks (Scandishake, Solcarb, Beneprotein) and cookies) as a possible treatment. Condition(s) listed: Crohn Disease and IBD.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 49
- Men only
Some of the main requirements, copied from the record:
- Male 18 - 49 years of age
- Having obtained his (or his legal representative's) written informed consent
- Evidence of ileal and or colon inflammatory involvement and clinically stable disease state and HBI ≤ 8
Plus 4 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 10 participants are expected to take part.
- Start date: 2024-02-02.
- Main results expected around 2027-08-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Canada.
Main thing being measured
- Requirement of Threonine in Adult Males with Crohn's Disease (1 - 6 months)
In the researchers’ words
The goal of the current study is to measure the requirement for threonine in patients with CD using the IAAO method and compare the requirement to previously determined threonine requirement estimated in young adults using the IAAO technique. It is hypothesize that the requirement for threonine in patients with CD will be higher than the threonine requirement previously determined in young adults using the IAAO…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease; IBD |
| Lead sponsor | The Hospital for Sick Children |
| Collaborators | MOUNT SINAI HOSPITAL |
| Enrollment | 10 (estimated) |
| Start date | 2024-02-02 |
| Primary completion (est.) | 2027-08-30 |
| First posted | 2021-02-05 |
| Last updated | 2025-05-30 |
| Official title | Determination of Threonine Requirement in Adult Males With Crohn's Disease Using the Indicator Amino Acid Oxidation (IAAO) Methodology |
| ClinicalTrials.gov ID | NCT04740541 |
Interventions
- Dietary Intakes (Reference protein drinks (Scandishake, Solcarb, Beneprotein) and cookies) (Other)
Reference protein drinks (Scandishake, Solcarb, Beneprotein) and cookies to meet nutritional requirements, 5 levels of threonine intakes
Full eligibility criteria (from the record)
Inclusion Criteria: * Male 18 - 49 years of age * Having obtained his (or his legal representative's) written informed consent * Evidence of ileal and or colon inflammatory involvement and clinically stable disease state and HBI ≤ 8 * Evidence of some active disease based on history of elevated CRP or parameters of active mucosal * No evidence of intestinal strictures that may affect the subjects' ability to consume a normal diet * Have maintained a stable weight for at least 3 months and not on enteral feed via tube * Willingness to participate in the study and completed the screening procedures (height, weight, fasting blood sample and medical history questionnaire) and willingness to consume the diet provided Exclusion Criteria: * Uncontrolled inflammation which will likely require surgery or escalation of therapy in the next 4 weeks * Concomitant treatment: corticosteroid > 20 mg/day * Subjects without any evidence of inflammatory activity * On medications known to affect protein and amino acid metabolism (steroids) * Recent significant weight loss * Individual on weight reducing diets * Inability to tolerate the diet * Subjects who cannot be expected to comply with the study procedures * Significant coffee consumption of more than 2 cups/day * Significant alcohol consumption of more than one drink/day
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| The Hospital for Sick Children | Toronto, Ontario | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.