Threonine Requirement in IBD Adults and Healthy Adult Controls

Sponsor

Nestlé (Industry)

Overall Status

Completed

CT.gov ID

NCT02423460

Collaborator

The Hospital for Sick Children (Other), Mount Sinai Hospital, Canada (Other)

Enrollment

Location

Arm

40.8

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis Crohn's Disease Healthy	Other: Threonine	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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 Start Date :

May 1, 2015

Actual Primary Completion Date :

Sep 17, 2018

Actual Study Completion Date :

Sep 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
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 Names: amino acid

Arm

Intervention/Treatment

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 Names:

amino acid

Outcome Measures

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 [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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