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OpenTrials
Completed

NCT Number: NCT02423460

Threonine Requirement in IBD Adults and Healthy Adult Controls

The daily requirement of threonine, an essential amino acid, will be evaluated in healthy adult males and in adult males with Crohn's Disease or ulcerative colitis using the indicator amino acid oxidation (IAAO) method. Participants will consume specially formulated diets with varying levels of threonine.

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G-1X8, Canada

About this study

Threonine is an essential amino acid which must be obtained from the diet. It is a component of mucin. Mucin, in turn, is a key protein in the mucous membrane that protects the lining of the intestine.

Inflammatory bowel disease (IBD) is a group of inflammatory conditions that affect the colon and small intestine. IBD primarily includes ulcerative colitis (UC) and Crohn's disease (CD). In UC, the inflammation is usually in the colon whereas in CD inflammation may occur anywhere along the digestive tract. Studies in animals have shown that more threonine is used when there is inflammation in the intestine.

The threonine requirement in healthy participants and in IBD patients will be determined using the indicator amino acid oxidation method. The requirement derived in healthy participants will be compared to that derived in patients with IBD.

Each participant will take part in two x 3 day study periods. The first two days are called adaptation days where the subjects will consume a liquid diet specially designed for him. The diet will be consumed at home. It contains all vitamins, minerals, protein and all other nutrients required. On the third day, the participant will come to the Hospital for Sick Children in Toronto. Subjects will consume hourly meals for a total of 8 meals and a stable isotope 13C-phenylalanine. Breath and urine samples will be collected to measure the oxidation of phenylalanine from which the threonine requirement will be determined.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(healthy controls):

  • Male age 18 - 40 years of age
  • Having obtained his (or his legal representative's) written informed consent.
  • Normally nourished and without any inter-current illness.
  • Absence of an active inflammatory process in the past month.

Exclusion criteria

(healthy controls):

  • Subject who cannot be expected to comply with the study procedures.
  • Currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study.

Inclusion criteria

Crohn's Disease and Ulcerative Colitis

  • Male age 18 - 40 years of age
  • Having obtained his (or his legal representative's) Written Informed Consent.
  • For both conditions, stable disease state and not malnourished per the treating physician.
  • CD: Harvey Bradshaw Index (HBI) ≤ 8, disease location: evidence of ileal and or colon inflammatory involvement, no known strictures
  • UC: Mayo Score ≤ 7 (or Partial Mayo Score ≤5)
  • No tube feeding - Subjects must be treated and followed by the Gastroenterology team at Mt. Sinai Hospital, Toronto.

Exclusion criteria

Crohn's Disease and Ulcerative Colitis

  • Uncontrolled inflammation which will likely require surgery or escalation of therapy in the next 4 weeks
  • Concomitant treatment:corticosteroids > 20mg/day
  • Subject who cannot be expected to comply with the study procedures. - Subjects not treated and followed by the Gastroenterology team at Mt. Sinai Hospital, Toronto

Treatment and study plan

Threonine

Other

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 disease and Ulcerative colitis.

Other names: amino acid

Primary outcomes

  1. Threonine requirement in those with Crohn's Disease, ulcerative colitis and in healthy controls determined using the indicator amino acid oxidation method

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • Mount Sinai Hospital, Canada
  • The Hospital for Sick Children

Registry information

Official study title

Threonine Requirement in Healthy Adult Subjects and in Patients With Crohn's Disease and With Ulcerative Colitis Using the Indicator Amino Acid Oxidation (IAAO) Methodology

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 22, 2015
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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