Dietary Intakes for Crohn's Disease
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Hospital for Sick Children
Must not be taking: Steroids
Disqualifiers: Uncontrolled inflammation, Recent weight loss, others
No Placebo Group
Trial Summary
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.
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.
12345Eligibility 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
+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.
+7 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
The Hospital for Sick ChildrenToronto, Canada
Loading ...
Who Is Running the Clinical Trial?
The Hospital for Sick ChildrenLead Sponsor
MOUNT SINAI HOSPITALCollaborator
References
Assessment of Dietary Adequacy and Quality in a Sample of Patients with Crohn's Disease. [2022]Both under-and over-nutrition are prevalent in patients with Crohn's Disease (CD). The aim of the present study was to evaluate dietary intake and compare it with relevant recommendations during active disease and remission, also taking into consideration the adequacy of energy reporting. Dietary quality was assessed through adherence to the Mediterranean diet and to the European dietary guidelines for cardiovascular disease prevention (CVD-score). Malnutrition was diagnosed with the GLIM criteria. There were 237 patients evaluated (54.9% males, 41.3 ± 14.1 years and 37.6% with active disease). In the total sample, high prevalence of overweight/obesity (61.6%) and low prevalence of malnutrition (11.4%) were observed, whereas 25.5% reported low protein intake in the sub-sample of adequate energy reporters. The mean MedDietScore was 28.0 ± 5.5 and the mean CVD-score was 5.25 ± 1.36, both reflecting moderate dietary quality. Patients with active disease reported higher prevalence of low protein intake, lower carbohydrate, fibers, fruits, vegetables, legumes, and sweets consumption and a lower MedDietScore compared to patients in remission. Consumption of fibers, fruits, vegetables, and legumes while in remission did not result in reaching the recommended intakes, and dietary quality was low as reflected by the MedDietScore. In conclusion, both protein undernutrition and energy overconsumption were prevalent in the current sample and overall patients adhered to a moderate quality diet irrespective of disease stage.
Diet counseling modifies nutrient intake of patients with Crohn's disease. [2016]The nutrient intake of 137 outpatients with Crohn's disease was recorded, and the effect of diet counseling was assessed. Half the patients received monthly diet counseling that was individualized and aimed at normalizing nutrient intake; the other half of the patients received no diet counseling and served as controls. Over the 6-month study period, the mean nutrient intakes met or exceeded the 1980 U.S. Recommended Dietary Allowances (RDAs) for all nutrients except folate in the men and iron and folate in the women. However, at study entry, for each nutrient there was a substantial proportion of patients whose intake did not meet the full RDA. Less than 50% of the men consumed the full RDA for energy and folate, and less than 50% of the women consumed the full RDA for energy, folate, calcium, iron, thiamin, and vitamin B-12. Monthly diet counseling sessions were associated with increases in the mean intake of most nutrients, whereas similar improvement was not observed in the control group members, who did not receive counseling. By 6 months, significantly more counseled than non-counseled patients were consuming the full RDA for protein, riboflavin, and vitamin C (p less than .05). Thus, diet counseling was found to be an important tool for improving the nutrient intake of outpatients with Crohn's disease.
Micronutrient Status in Adult Crohn's Disease during Clinical Remission: A Systematic Review. [2023]Adults with Crohn's disease (CD) may be at risk of micronutrient insufficiency in clinical remission through restrictive eating, malabsorption, abnormal losses or inflammation. This systematic review synthesises the literature on micronutrient insufficiency in CD in clinical remission in terms of the prevalence of low circulating micronutrient concentrations and as a comparison against a healthy control (HC). Studies were included if the population was predominantly in remission. A total of 42 studies met the inclusion criteria; 12 were rated as low quality, leaving 30 studies covering 21 micronutrients of medium/high quality that were included in the synthesis. Vitamins D and B12 were the most frequently reported nutrients (8 and 11); there were few eligible studies for the remaining micronutrients. The prevalence studies were consistent in reporting individuals with low Vitamins A, B6, B12 and C, β-carotene, D, Magnesium, Selenium and Zinc. The comparator studies were inconsistent in finding differences with CD populations; Vitamin D, the most reported nutrient, was only lower than the HC in one-quarter of the studies. Adult CD populations are likely to contain individuals with low levels of one or more micronutrients, with the most substantial evidence for Vitamins D and B12. The studies on other micronutrients are of insufficient number, standardisation and quality to inform practice.
Dietary fiber and nutrient intake in Crohn's disease. [2018]The mean daily intake of dietary fiber, sugar, starch, fat, protein, and total energy was determined in 35 patients with Crohn's disease and 70 normal controls by obtaining individual dietary histories. For each patient with Crohn's disease there two controls, matched for age, sex, and socioeconomic background. In the patients with Crohn's disease the mean dietary fiber intake was established as 26.6 +/- 1.4 g/day, compared to 22.3 +/- 0.9 g/day in the controls, and was thus significantly higher (P less than 0.05). When compared with the controls, the patients with Crohn's disease also exhibited a significantly higher consumption of sugar 156 +/- 14 versus 91 +/- 5 g/day (P less than 0.001), starch (211 +/- 10 versus 170 +/- 9 g/day (P less than 0.01)), and total energy (14.4 +/- 0.7 versus 12.3 +/- 0.5 MJ/ day (P less than 0.01)).
What can Crohn's patients eat? [2006]Seventy-one patients with Crohn's disease were interviewed about their diet. All had undergone surgery for the condition. Thirty-seven patients had an ileostomy and 34 patients did not. Information about the effect of 32 foodstuffs and drinks, what advice had been given, who had given it, and the patients' attitude to food, was obtained. Twenty-seven fit health workers acted as a control group. Corn, nuts, fizzy drinks, raw fruits, shellfish and pickles in the ileostomy patients and nuts, raw fruit and tomatoes in the non-ileostomy patients gave rise to problems. These differences were statistically significant (P less than 0.01) when compared to the control group. Chicken, white bread, rice, potatoes and lamb were the foods least likely to provoke symptoms in all the groups. "Eat what you can" was the commonest dietary advice given and physicians were the most important source of that advice. More than half of the patients thought their diet was adequate but more Crohn's patients than controls took regular vitamin supplements. Although only two patients considered that diet might be responsible for their disease, most thought dietary factors important in controlling symptoms or aiding recovery.