Status:
RECRUITING
Threonine Requirement in Adult Males With Crohn's Disease Using IAAO
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
MOUNT SINAI HOSPITAL
Conditions:
Crohn Disease
IBD
Eligibility:
MALE
18-49 years
Phase:
NA
Brief Summary
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...
Detailed Description
BACKGROUND The current Dietary Reference Intake (DRI) recommendations for essential amino acid requirements are based on recommendations for young healthy adults and have not been directly determined ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04740541
Start Date
February 2 2024
End Date
August 30 2027
Last Update
May 30 2025
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8