Threonine Requirement in Adult Males With Crohn's Disease Using IAAO

Launched by THE HOSPITAL FOR SICK CHILDREN · Feb 4, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how much threonine, an important amino acid, is needed by adult males who have Crohn's disease. The researchers believe that men with this condition may need more threonine than younger adults without Crohn's. To find this out, the study will recruit up to 10 men aged 18 to 49 who are in stable health but have evidence of inflammation in their intestines. Participants will undergo a few assessments to measure their height, weight, and overall health before starting a special diet that includes protein shakes for a few days.

During the study, participants will consume a carefully planned diet and have their breath and urine samples collected to measure how their bodies process threonine. This will help researchers understand the specific dietary needs of men with Crohn's disease. It's important to know that participants can leave the study at any time if they find the diet difficult to follow or if they experience discomfort. The study aims to improve the understanding of nutritional needs in people with Crohn's disease, which could lead to better dietary recommendations in the future.

Gender

MALE

Eligibility 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