Determination of Threonine Requirements in Healthy School-aged Children

NCT02660892 | Completed

• 1 other identifier: H15-02691
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Threonine is an indispensable amino acid (nutrient containing nitrogen), which cannot be made in the body and must be consumed from food. Amino acids are the building blocks of protein in your body, and need to be eaten in required amounts to maintain health and growth. Deficiency in threonine can affect small intestine growth due to its structural importance in the intestinal protein mucin. While threonine is found in many foods, deficiency can occur in developing countries where nutrition is primarily plant based, and low in available protein. Therefore, the purpose of this study is to determine the requirement of the indispensable amino acid Threonine, in school-aged children (6-10y). Secondly, we wish to determine the availability of threonine from three test proteins (soy, green pea, casein).

Conditions

Threonine Requirements in Children

Keywords

IAAO; Threonine; Children

Outcome Measures

Primary Outcomes (1)

• 13 Co2 production

  Urine and breath samples will be collected during the study day, to measure the rate of oxidation of tracer phenylalanine in the expired breath, and flux enrichment in urine.

  8 hours (1 study day)

Study Arms (1)

Protein Intake

EXPERIMENTAL

Threonine intake - Dietary supplement

Dietary Supplement: Protein intake

Interventions

Protein intake DIETARY_SUPPLEMENT

Oral consumption of eight hourly experimental meals * 4 tracer free experimental meals containing a mixture of free amino acids and calories from protein free flavoured liquid, protein free cookies and corn oil * 4 isotopically labeled experimental meals.

Protein Intake

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children between 6 and 10 Y
• No history of chronic disease or metabolic disorders
• No food allergies
• No recent illness or antibiotic consumption
• Children with a normal, healthy, body weight (between 3rd and 85th percentiles for their age group for weight) (Dietitians of Canada, 2015)

You may not qualify if:

• Children under 6 years' old
• Children over 10 years' old
• Children with a history of disease or metabolic disorders
• Children with any food allergies
• Children taking prescription medication
• Children with a history of being underweight, overweight, or obese (Dietitians of Canada, 2015; Onis et al., 2007)
• o Below 3rd percentile for weight, Above 85th percentile for weight
• Female children who have commenced menstruation

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital Research Institute

Vancouver, British Columbia, V5Z4H4, Canada

Location

Study Officials

• Rajavel Elango, Ph.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 21, 2016
• Study Start: May 26, 2016
• Primary Completion: July 5, 2017
• Study Completion: October 1, 2017
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)