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Threonine Requirement in IBD Adults and Healthy Adult Controls

Primary Purpose

Ulcerative Colitis, Crohn's Disease, Healthy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Threonine
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Healthy Controls, Crohn's Disease

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Threonine requirement

Arm Description

The threonine requirement in healthy male subjects and in patients with Crohn's disease and Ulcerative colitis

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
April 12, 2015
Last Updated
November 2, 2018
Sponsor
Société des Produits Nestlé (SPN)
Collaborators
The Hospital for Sick Children, Mount Sinai Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02423460
Brief Title
Threonine Requirement in IBD Adults and Healthy Adult Controls
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
September 17, 2018 (Actual)
Study Completion Date
September 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)
Collaborators
The Hospital for Sick Children, Mount Sinai Hospital, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Crohn's Disease, Healthy
Keywords
Ulcerative Colitis, Healthy Controls, Crohn's Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Threonine requirement
Arm Type
Experimental
Arm Description
The threonine requirement in healthy male subjects and in patients with Crohn's disease and Ulcerative colitis
Intervention Type
Other
Intervention Name(s)
Threonine
Other Intervention Name(s)
amino acid
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G-1X8
Country
Canada

12. IPD Sharing Statement

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Threonine Requirement in IBD Adults and Healthy Adult Controls

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