Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 49 Years|
- - 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|The Hospital for Sick Children|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Crohn Disease, IBD|
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 in patients with Crohn's disease. Protein and amino acids are key components of our diet. Having defined the requirement of the essential amino acid, Threonine in healthy adults using the IAAO, the investigators are now in an ideal position to define the needs in vulnerable populations, such as patients with chronic inflammatory conditions, such as Crohn's disease (CD). Studies in animals suggest an increase in the threonine requirement in Crohn's and colitis models. If this is also true in humans, knowledge of the threonine requirement in patients with IBD could provide valuable information for improvement in medical nutritional management of this patient population. Improved medical nutrition therapy could likely shorten recovery time and/or increase the period of remission in patients with IBD. Method: Indicator Amino Acid Oxidation. Hypothesis: It is hypothesized 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 (19 mg/kg/d). Objectives: 1. To determine the requirement for threonine in patients with CD using the IAAO technique; by measuring the oxidation of L-[1-13 C] phenylalanine to 13 CO 2 [F 13 CO 2] in response to graded intakes of leucine. 2. To compare, on the basis of body weight and fat-free mass, the requirement derived from this study to the requirement of threonine determined previously in young adults by the IAAO method. Subjects: Up to 10 clinically stable patients with CD will be recruited from the IBD Clinic at Mt. Sinai Hospital, Toronto, who will be identified by Dr. Mark Silverberg for this study 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. We need the pre-study assessment 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).
- - The voluntaries will receive financial compensation for the costs incurred while participating in the study.
- - All procedures in the study will be approved by the Research Ethics Board at SickKids.
- - On days 1 and 2, the subject will consume an adaptation diet and on the 3rd day participate in an 8-hour testing period.
- - Dietary intakes during the 2-day adaptation period before the day 3 IAAO study will be provided in the form of lactose-free milk shakes (Scandishake) with added carbohydrate (SolCarb) and protein (beneprotein) to meet the subjects' requirement.
- - 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.
- - Tyrosine will be provided in excess at 40 mg/kg/day.
- - Phenylalanine will be provided at a constant intake of 20mg/kg/d.
- - Threonine will be provided at graded intakes ranging from 3-45 mg/kg/d and alanine levels will be adjusted to balance the changing levels of leucine and ensure formulas are isonitrogenous.
- - 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 1cup clear coffee.
- - During the 8-hr study day, no other food or drink will be consumed except water.
- - The study day diet will be divided into 8 isonitrogenous, isocaloric meals each representing one-twelfth of the total subject´s daily requirements.
- - On the morning of each study day, the subject will consume 4 of the hourly meals at home and then visit the research laboratory.
- - Up to 5 dietary threonine intake levels will be tested in random order as mentioned under "experimental design".
- - 1-13C phenylalanine will be given as the tracer in the 5th meal and continue to be administered with the remaining meals.
- - 1-13C phenylalanine will be used as the isotope.
- - At the same time which the priming dose of L-[13C]phe is administered, an oral priming dose of 0.176 mg/kg of bicarbonate (NaH13CO3) will also be given.
- - The amount of phenylalanine given as the isotope on the study day will be subtracted from dietary phenylalanine to maintain the total dietary intake at 20 mg Phe /kg/d.
- - Tyrosine intake will be maintained at 40 mg∙kg-1∙d-1 to ensure an excess of tyrosine.
- - Breath and urine samples are collected periodically before and after the tracers are consumed.
- - 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.
- - Breath: expired 13 CO2 enrichment will be measured by continuous flow isotope ratio mass spectrometer (IRMS).
- - Urinary 1-13C phenylalanine enrichment will be analyzed by gas chromatography tandem mass spectrometry (LC-MS-MS).
Experimental: Threonine Requirement in CD Patients
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.
Other: - Dietary Intakes (Reference protein drinks (Scandishake, Solcarb, Beneprotein) and cookies)
Reference protein drinks (Scandishake, Solcarb, Beneprotein) and cookies to meet nutritional requirements, 5 levels of threonine intakes
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8