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RecruitingNAINTERVENTIONAL

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

This study aims to discover the exact amount of a nutrient called threonine needed by adult men with Crohn's disease. Threonine is an essential building block found in protein. Researchers believe that people with Crohn's might need more threonine than healthy individuals. By finding this out, they hope to improve nutritional guidance for patients, potentially helping them recover faster or stay well for longer. The study involves diet changes, special drinks and cookies, and collecting breath and urine samples to track how the body uses threonine. Participants will be stable adult men with Crohn's disease from Toronto.

At a glance

Status
Recruiting
Phase
NA
Sponsor
The Hospital for Sick Children
Enrolment target
10
Start
02 Feb 2024
Estimated completion
30 Aug 2027

What is this study about?

This study is looking into an important nutrient called threonine, which is a type of amino acid – the building blocks of protein. Your body needs threonine from your diet to work properly. For healthy adults, we already have a good idea of how much threonine is needed. However, we don't know if this amount is the same for people with long-term conditions like Crohn's disease.

Crohn's disease can affect how your body uses nutrients. Some previous studies in animals have suggested that those with Crohn's-like conditions might need more threonine. If this is also true for humans, knowing the correct amount could help doctors and dietitians provide better dietary advice and support for people with Crohn's. This might lead to improved health, quicker recovery from flare-ups, or longer periods of feeling well.

The main goal is to compare the threonine needs of men with Crohn's disease to those of healthy young adults. By understanding these differences, researchers hope to develop better ways to manage nutrition for Crohn's patients, which is a really important part of staying healthy with the condition.

Key takeaways

  • Exploring if men with Crohn's need more threonine (a protein building block) than healthy adults.
  • Aims to improve dietary advice for Crohn's patients.
  • Involves carefully controlled diets, including special drinks and cookies.
  • Requires several 3-day study periods, including a study day at the clinic.
  • Breath and urine samples will be taken to measure how the body uses nutrients.
  • Participants can leave the study at any time if they wish.

Who may be eligible?

This study is looking for men aged between 18 and 49 years old who have Crohn's disease. You'd need to be in a generally stable condition, without severe or uncontrolled inflammation that might require urgent medical changes.

To be eligible, you should have some signs of active Crohn's disease, either in previous blood tests or medical history, but without serious blockages in your gut. You also need to have kept a stable weight for at least three months and not currently be receiving nutrition through a feeding tube. You must be willing to follow the study diet and procedures.

However, you won't be able to join if your Crohn's is severely active, you're on high doses of certain steroid medications (more than 20mg per day), or if you've recently lost a lot of weight. Other reasons for not being suitable include drinking a lot of coffee (more than 2 cups per day) or alcohol (more than one drink per day), or if you find it hard to stick to study procedures or diets.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you a man between 18 and 49 years old?
  2. Do you have Crohn's disease that is generally stable?
  3. Have you maintained a stable weight for at least three months?
  4. Are you able and willing to follow a very specific diet for short periods?
  5. Are you not currently on high doses of steroid medication for your Crohn's?
  6. Do you consume less than 2 cups of coffee and 1 alcoholic drink per day?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first visit The Hospital for Sick Children in Toronto for a 'pre-study assessment.' This visit will take about 3 hours and will happen after you've fasted (not eaten) for 10 hours. During this assessment, we'll measure your height, weight, body composition (fat and muscle), and energy use while resting. We'll also ask about your medical history and take a fasting blood sample. This information helps us plan your specific diet for the study.

The main part of the study involves three separate 3-day periods. For each period, you'll spend two days adjusting to a special diet. During these two 'adaptation days,' you'll only consume lactose-free milkshakes and protein-rich cookies provided by the study, along with water, clear tea, or clear coffee. On the third day, called the 'study day,' you'll continue with specially prepared liquid meals and protein-free cookies, provided every hour for eight hours. Throughout this day, we'll collect breath and urine samples at specific times to measure how your body uses threonine. You'll also receive a daily multivitamin.

On the 'study day,' one of your meals will involve a special measurement of your breath for about 20 minutes to see how much carbon dioxide your body produces. Please remember, you can choose to leave the study at any time, for any reason, particularly if you have trouble with the diet.

Potential risks and benefits

Participating in this study might not directly benefit you, but it could help us understand Crohn's disease better, potentially leading to improved nutritional care for many people in the future. There are no major risks identified, but you might find the study diet challenging in terms of taste or causing changes in your bowel habits (like loose stools or constipation). If you experience any discomfort or simply don't want to continue, you are free to withdraw from the study at any time without giving a reason.

Locations (1)

  • The Hospital for Sick Children
    Verified postcode
    Toronto, Canada· Recruiting

Common questions

What is threonine, and why is it important?

Threonine is an essential building block found in protein. Your body needs it through your diet for important functions, and this study wants to see how much people with Crohn's need.

Will I have to stay in the hospital for the study?

No, you will attend appointments at the Clinical Research Centre. The study involves several 3-day periods, but you won't stay overnight.

What kind of food will I eat during the study?

You'll be given special lactose-free milkshakes, cookies, and a liquid formula, designed to be exactly controlled for the study. No other food or drinks (except water, clear tea/coffee) are allowed.

What happens if I don't like the food or feel unwell?

If you find the diet difficult or experience any side effects, you can leave the study at any point. Your comfort and well-being are important.

How long will the total study take?

The study involves several 3-day periods, each including two 'adaptation' days at home and one 'study day' at the clinic. The pre-study assessment takes about 3 hours.

How to find out more

Alyssa Paoletti, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Threonine Requirement in Adult Males With Crohn's Disease Us…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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