Determination of Threonine Requirements in Healthy School-aged Children

NCT ID: NCT02660892

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-26
• Study Completion Date: 2017-10-01

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).

Detailed Description

The threonine intake requirement for children are based on factorial calculations. In the current study we will use a new and modern technique, the indicator amino acid oxidation technique (IAAO), to determine threonine requirements in children.

This technique is a newer technique which involves the consumption of protein shakes composed of specific amounts of threonine mixed with a stable isotope tracer. The oxidation of this isotope will be measured in urine and breath to determine a breakpoint (requirement) of threonine.

Determining the requirement for threonine, as well as the availability of threonine from various food products will help us to develop better food recommendations for children.

Research Method This study will be carried out in a repeated measures design. Participants will be recruited and screened for eligibility. Six participants will be brought in for 6 testing visits with reference amino acid, where they will be randomized to a level of threonine intake. A further 3 visits will be carried out during which participants will be randomized to a level of threonine consumption derived from alternative proteins (casein, soy, peas) which is at a threshold below the requirement for threonine to determine availability.

Conditions

Threonine Requirements in Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Protein Intake

Threonine intake - Dietary supplement

Group Type: EXPERIMENTAL

Protein intake

Intervention Type: 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.

Interventions

Protein intake

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Rajavel Elango, PhD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajavel Elango, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

BC Children's Hospital Research Institute

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H15-02691

Identifier Type: -

Identifier Source: org_study_id