Dietary Intakes for Crohn's Disease

Overseen By Mahroukh Rafii, BSc

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Must not be taking: Steroids

Disqualifiers: Uncontrolled inflammation, Recent weight loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether people with Crohn's disease require more threonine, a key nutrient, compared to healthy young adults. Participants will follow a special diet to assess how their bodies process threonine. Men with stable Crohn's disease, who have not experienced significant weight changes recently, may be suitable candidates. As an unphased study, this trial provides a unique opportunity to enhance scientific understanding of nutritional needs in Crohn's disease.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on medications known to affect protein and amino acid metabolism, like steroids.

What prior data suggests that this dietary protocol is safe for patients with Crohn's Disease?

Research shows that threonine, a type of amino acid, is usually safe for most people. It is present in many proteins in the body. Studies have not found any serious side effects from taking threonine in healthy adults or those with Crohn's Disease when used in controlled amounts. This study aims to determine how much threonine people with Crohn's need compared to healthy adults. Participants may leave the study if they find the diet difficult. So far, no major safety issues have been reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Crohn's disease, which often include anti-inflammatory drugs, immunosuppressants, and biologics, threonine is a dietary amino acid that researchers are investigating for its potential benefits. Threonine is unique because it may help enhance the gut lining's integrity, which is often compromised in Crohn's patients. This approach is exciting as it suggests a nutritional method to manage the disease, potentially reducing reliance on medications with significant side effects. Researchers hope threonine could offer a more natural and supportive way to manage symptoms and improve intestinal health.

What evidence suggests that threonine might be an effective treatment for Crohn's disease?

Research has shown that people with Crohn's disease might need more threonine, an important nutrient, than those without the condition. One study found that an inflamed gut absorbs more threonine. This trial will specifically investigate the threonine requirements in Crohn's disease patients. Other research has found that Crohn's patients often have different levels of nutrients like threonine, which can affect their health. These findings suggest that adjusting threonine intake might help improve the condition. ^{1 4 6 7 8}

Who Is on the Research Team?

Glenda Courtney-Martin, PhD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

This trial is for male adults aged 18-49 with Crohn's Disease showing some active disease signs. They must have stable weight without tube feeding, be able to eat normally despite their condition, and not be on high-dose steroids or other drugs affecting protein metabolism. Heavy drinkers and those who consume a lot of coffee are excluded.

Inclusion Criteria

Having obtained his (or his legal representative's) written informed consent

I am a man aged between 18 and 49.

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

You drink more than 2 cups of coffee per day.

Subjects who cannot be expected to comply with the study procedures

I am taking more than 20 mg/day of corticosteroids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-study Assessment

Participants undergo pre-study assessment including height, weight, fat mass, fat free mass, resting metabolic rate, and medical history

1 day

1 visit (in-person)

Adaptation

Participants adapt to a prescribed diet for 2 days to allow the body to adjust to an adequate amount of protein

2 days

No visits required

Study Day

Participants undergo a study day where threonine intake is randomly assigned and phenylalanine kinetics are measured

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the study day

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Threonine

Trial Overview The study aims to determine the threonine (an amino acid) requirements in Crohn's patients using a technique called IAAO compared to young healthy adults' needs. Participants will follow a special diet including shakes and cookies for three days while their body's response is monitored through breath and urine samples.

How Is the Trial Designed?

Group I: Threonine Requirement in CD Patients Experimental Treatment 1 Intervention

Males aged 18 - 49 with stable Crohn's disease will be seen for pre-study They will be studied up to 5 times for different levels of threonine intakes.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

MOUNT SINAI HOSPITAL

Collaborator

Trials

44

Recruited

17,000+

Published Research Related to This Trial

Adults with Crohn's disease in clinical remission are at risk for low levels of several micronutrients, particularly Vitamins D and B12, based on a systematic review of 42 studies, with 30 studies providing medium to high-quality data.

While many individuals with Crohn's disease showed low levels of various micronutrients, the evidence for significant differences compared to healthy controls was inconsistent, especially for Vitamin D, which was only lower in one-quarter of the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Micronutrient Status in Adult Crohn's Disease during Clinical Remission: A Systematic Review. McDonnell, M., Sartain, S., Westoby, C., et al.[2023]

In a study of 71 patients with Crohn's disease, certain foods like corn, nuts, and raw fruits were found to cause significant problems for patients with ileostomies, while non-ileostomy patients had issues with nuts and tomatoes, highlighting the importance of individualized dietary advice.

Despite many patients believing their diet was adequate, over half took regular vitamin supplements, indicating a concern for nutritional deficiencies, and most patients recognized that diet plays a role in managing symptoms and recovery from Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What can Crohn's patients eat? McDonald, PJ., Fazio, VW.[2006]

In a study of 237 patients with Crohn's Disease, both undernutrition (especially low protein intake) and overnutrition (high prevalence of overweight/obesity at 61.6%) were common, indicating a complex nutritional challenge for these patients.

Patients with active Crohn's Disease had poorer dietary quality, consuming fewer fruits, vegetables, and fibers, and achieving lower adherence to the Mediterranean diet compared to those in remission, highlighting the need for improved dietary guidance during active disease phases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Dietary Adequacy and Quality in a Sample of Patients with Crohn's Disease. Karachaliou, A., Yannakoulia, M., Bletsa, M., et al.[2022]

In a study of 137 outpatients with Crohn's disease, individualized monthly diet counseling significantly improved nutrient intake, with more patients meeting the Recommended Dietary Allowances (RDAs) for key nutrients compared to those who did not receive counseling.

By the end of the 6-month study, significantly more patients who received diet counseling were consuming the full RDA for protein, riboflavin, and vitamin C, highlighting the effectiveness of dietary guidance in managing nutrient deficiencies in Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet counseling modifies nutrient intake of patients with Crohn's disease. Imes, S., Pinchbeck, BR., Thomson, AB.[2016]

Patients with Crohn's disease have a significantly higher mean daily intake of dietary fiber (26.6 g) compared to normal controls (22.3 g), suggesting that fiber consumption may differ in this population.

In addition to higher fiber intake, patients with Crohn's disease also consume significantly more sugar (156 g vs. 91 g), starch (211 g vs. 170 g), and total energy (14.4 MJ vs. 12.3 MJ) than controls, indicating potential dietary differences that could impact disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fiber and nutrient intake in Crohn's disease. Kasper, H., Sommer, H.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6066806/

Plasma-Free Amino Acid Profiles in Crohn's Disease We aimed to clarify the relationship between plasma-free amino acid (PFAA) profiles and the Crohn's disease (CD) activity index (CDAI) in patients with CD.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622067189

Intestinal Inflammation Increases Gastrointestinal ... PDV uptake of arterial threonine increased from 25 ± 14 μmol·kg−1.h−1 in the control group to 171 ± 35 μmol·kg−1.h−1 in the TNBS-treated group (P < 0.001). In ...

3. medrxiv.org medrxiv.org/content/10.1101/2024.10.03.24314812v1.full-text

Metabolic alterations in Crohn's disease: A Systematic ... Consistently low levels of citrate in the urine samples of CD patients may be linked to poor absorption from the diet or increased cellular ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02423460

Threonine Requirement in IBD Adults and Healthy ... 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 ...

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2023.1245574/full

Amino acid profiles, disease activity, and protein intake in ... The present study aimed to explore serum AA concentrations in adult patients with CD, looking into their variations due to disease activity, surgery and ...

6. valudor.com valudor.com/wp-content/uploads/2025/04/L-Threonine.pdf

Safety Data Sheet: L-threonine Avoid contact with skin and eyes. Wearing of suitable protective equipment (including personal protective equipment referred to under. Section 8 of the safety ...

7. fishersci.com fishersci.com/store/msds?partNumber=BP394100&productDescription=L-THREONINE100GM&vendorId=VN00033897&countryCode=US&language=en

SAFETY DATA SHEET Physical State. Powder Solid. Appearance. White. Odor. Odorless. Odor Threshold. No information available. pH. 5.0-6.5. Melting Point/Range.

8. carlroth.com carlroth.com/medias/SDB-T206-AU-EN.pdf?context=bWFzdGVyfHNlY3VyaXR5RGF0YXNoZWV0c3wyMzE0MjF8YXBwbGljYXRpb24vcGRmfGFHWTBMMmhrWWk4NU1UYzFOekk1TlRZNU9ESXlMMU5FUWw5VU1qQTJYMEZWWDBWT0xuQmtaZ3xlZWY1YTIwNzFhN2MyYTM4ZTYyM2E0NzE1MjI2YTdiMjA1Y2Q3NWRmODE0MzZmMGJlNDBjYTIxOGQ0NGZmOGM5

Safety Data Sheet: L-threonine Does not contain an endocrine disruptor (ED) at a concentration of ≥ 0,1%. SECTION 3: Composition/information on ingredients. 3.1. Substances. Name of substance.