Threonine Requirement in IBD Adults and Healthy Adult Controls

NCT02423460 | Completed

• 1 other identifier: 1000046356
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Crohn's Disease; Healthy

Keywords

Ulcerative Colitis; Healthy Controls; Crohn's Disease

Outcome Measures

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

  2 years

Study Arms (1)

Threonine requirement

EXPERIMENTAL

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

Other: Threonine

Interventions

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.

Also known as: amino acid

Threonine requirement

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• The Hospital for Sick Children: collaborator
• Mount Sinai Hospital, Canada: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G-1X8, Canada

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Interventions

Threonine; Amino Acids

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Essential; Amino Acids, Peptides, and Proteins; Amino Acids, Neutral

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2015
• First Posted: April 22, 2015
• Study Start: May 1, 2015
• Primary Completion: September 17, 2018
• Study Completion: September 23, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

CA (1)