Measuring threonine needs in adult males with Crohn's disease
Determination of Threonine Requirement in Adult Males With Crohn's Disease Using the Indicator Amino Acid Oxidation (IAAO) Methodology
This study is trying to find out how much threonine adult men with Crohn's disease need compared to healthy young adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Male |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04740541 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the threonine requirement in adult males with Crohn's disease using the Indicator Amino Acid Oxidation (IAAO) method. It will compare the threonine needs of these patients to previously established requirements in healthy young adults. Up to 10 clinically stable patients will be recruited from the IBD Clinic at Mt. Sinai Hospital and followed at The Hospital for Sick Children in Toronto. Participants will undergo a pre-study assessment to evaluate their health metrics before consuming a controlled diet to measure threonine oxidation.
Who should consider this trial
Good fit: Ideal candidates are male adults aged 18-49 with clinically stable Crohn's disease and specific inflammatory involvement.
Not a fit: Patients with uncontrolled inflammation or those requiring immediate surgical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved nutritional management for patients with Crohn's disease, potentially enhancing recovery and prolonging remission.
How similar studies have performed: While studies in animals suggest increased threonine requirements in Crohn's disease, this approach in humans is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto, Ontario
- The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Glenda Courtney-Martin, PhD, RD — The Hospital for Sick Children
- Study coordinator: Alyssa Paoletti, PhD
- Email: alyssa.paoletti@sickkids.ca
- Phone: 4168137454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.