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Trial record 1 of 52 for:    threonine
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Threonine Requirement in IBD Adults and Healthy Adult Controls

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Nestlé
Sponsor:
Collaborators:
The Hospital for Sick Children
Mount Sinai Hospital, Canada
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT02423460
First received: April 12, 2015
Last updated: September 8, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Ulcerative Colitis Crohn's Disease Healthy Other: Threonine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official 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

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 105
Study Start Date: May 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Threonine requirement
The threonine requirement in healthy male subjects and in patients with Crohn's disease and Ulcerative colitis
Other: Threonine
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 Name: amino acid

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02423460

Contacts
Contact: Theodore Wlodkowski, MS 973-593-7514 theodore.wlodkowski@rd.nestle.com

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G-1X8
Contact: Mahroukh Rafi, BSc    4168137454    mahroukh.rafii@sickkids.ca   
Contact: Mary Ann Ryan, BComm    4168137454    maryann.ryan@sickkids.ca   
Sponsors and Collaborators
Nestlé
The Hospital for Sick Children
Mount Sinai Hospital, Canada
  More Information

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02423460     History of Changes
Other Study ID Numbers: 1000046356
Study First Received: April 12, 2015
Last Updated: September 8, 2016

Keywords provided by Nestlé:
Ulcerative Colitis
Healthy Controls
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 21, 2017