10 Participants Needed

Dietary Intakes for Crohn's Disease

AP
MR
Overseen ByMahroukh Rafii, BSc
Age: 18 - 65
Sex: Male
Trial Phase: Academic
Sponsor: The Hospital for Sick Children
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

How does the treatment Threonine differ from other treatments for Crohn's Disease?

Threonine is an amino acid that may help improve protein intake in Crohn's Disease patients, who often experience low protein consumption. Unlike standard drug treatments, Threonine focuses on dietary supplementation to address nutritional deficiencies common in Crohn's Disease.12345

What is the purpose of this trial?

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 method. Up to 10 clinically stable patients with CD will be recruited from the IBD Clinic at Mt. Sinai Hospital, Toronto, and subsequently followed up at the Clinical Research Center (CRC), The Hospital for Sick Children (SickKids), Toronto, Canada. Before the study begins, the participants will be required to visit the CRC (Room 5500 Hill Wing, The Hospital for Sick Children) for a pre-study assessment of their height, weight, fat mass, fat free mass, resting metabolic rate and medical history. These assessments will take about 3 hours to complete. They will need to have been fasted for 10 hours prior to the pre-study assessment. The pre-study assessment is needed to calculate their dietary requirements for the study, and to assess health status. After signing the consent form, the subjects will complete the screening procedures (height, weight, fasting blood sample and medical history questionnaire, BIA, Skinfold and calorimetry).Each study will consist of a 2-day adaptation period to a prescribed diet in accordance with the energy requirement of the subject and 1-study day. The diet will provide an adequate amount of protein, of 1 g protein/kg/d. The 2-day adaptation period is to allow the body to adapt to an adequate amount of protein as it has been shown that protein kinetics is altered without it.Dietary intakes during this time will be provided in the form of lactose-free milk shakes (Scandishake) with added carbohydrate (SolCarb) and protein (beneprotein) to meet the subjects' requirement.Following the 2 days of adaptation is the study day where threonine intake will be randomly assigned and phenylalanine (Phe) kinetics will be measured with the use of isotopically labelled Phe. On this day, VCO2 will be measured by calorimetry immediately after the 5th meal for a period of 20 minutes.On the study day (3rd day of each 3-day period), the diet will be provided as 8 hourly isocaloric, isonitrogenous meals made up of a flavored liquid formula and protein free cookies developed for use in amino acid kinetic studies. Each meal will represent 1/12th of the subject's total daily requirements. The nitrogen (protein) content of the diet will be provided in the form of a crystalline amino acid mixture based on the amino acid composition of egg protein.* A daily multivitamin supplement will be provided during the study period.* No other food or beverages will be consumed on the adaptation days except water, 1 cup clear tea, or 1 cup clear coffee.* During the 8-hr study day, no other food or drink will be consumed except water.* Urine and breath samples will be collected at baseline and at isotopic steady state.* Breath samples will be collected simultaneously with urine samples.* Five baseline breath samples will be collected 60, 45, 30, 15 min, and just before the tracer protocol begins.* Three baseline urine samples will be collected 60, 30 min, and just before the tracer protocol begins.* Four plateau breath samples will be collected every 15 minutes 2.5 h after the tracer protocol begins.* Three plateau breath samples will be collected every 30 minutes 2.5 h after the tracer protocol begin* Breath samples will be collected with subjects breathing into an Exetainers plastic tube and samples will be stored in pre-evacuated glass tubes at room temperature until analysis.* Urine samples will be collected in Eppendorf tubes and stored at - 20 º C until analyzed for 1-13C phenylalanine enrichment.* The rate of CO2 production (VCO2) will be measured on each testing day using a ventilated hood indirect calorimeter at meal 5 to quantify 13CO2 excretion in breath.Subjects can choose to withdraw from the study at any time and for any reason, based on his/her individual judgment. In particular, if a subject is unable to tolerate the diet, whether it is regards to taste, loose stools or constipated stools, he/she has the right to withdraw at any time during the study.

Research Team

Glenda Courtney-Martin | Department of ...

Glenda Courtney-Martin, PhD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

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
See 4 more

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.
See 7 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Threonine Requirement in CD PatientsExperimental Treatment1 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.

Find a Clinic Near You

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+

Findings from Research

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.
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.
Diet counseling modifies nutrient intake of patients with Crohn's disease.Imes, S., Pinchbeck, BR., Thomson, AB.[2016]
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.
Micronutrient Status in Adult Crohn's Disease during Clinical Remission: A Systematic Review.McDonnell, M., Sartain, S., Westoby, C., et al.[2023]

References

Assessment of Dietary Adequacy and Quality in a Sample of Patients with Crohn's Disease. [2022]
Diet counseling modifies nutrient intake of patients with Crohn's disease. [2016]
Micronutrient Status in Adult Crohn's Disease during Clinical Remission: A Systematic Review. [2023]
Dietary fiber and nutrient intake in Crohn's disease. [2018]
What can Crohn's patients eat? [2006]
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