Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Length of Adaptation and Threonine Requirement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04585087
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : October 19, 2021
Sponsor:
Information provided by (Responsible Party):
Glenda Courtney-Martin, The Hospital for Sick Children

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study aims to determine if the body's needs for threonine (an amino acid which is an essential building block for protein) is different when assessed after 1, 3 or 6 days of adaptation to the level of threonine intake being studied.

Condition or disease Intervention/treatment Phase
Healthy Other: Dietary Intakes Not Applicable

Detailed Description:

Our method, the Indicator Amino Acid Oxidation (IAAO) method has been used before to look at amino acid requirements. Over the years, we have changed our method to make our studies on amino acid requirements safer to use in specific vulnerable populations like babies or older adults. For example, we have shown that we only need to collect breath and urine samples instead of collecting blood.

Another feature of our method is that we require subjects to consume personalized diets for 3 days at a time, repeated for up to 7 times. These personalized diets are important as they allow us to study the amount of amino acids needed by the body. The body's metabolism changes with different intakes of amino acids. We measure this change in metabolism by collecting breath and urine samples on the 3rd day of each diet period. However, we do not know if this specific length of time for the personalized diets (i.e. 3 days) is sufficient or whether more time is needed for the body to adjust to the amount of amino acids provided. There is a possibility that 3 days is not enough time and our results (i.e. our estimates of amino acid needs) may be different if we allow more time.

The purpose of this study is to find out if the threonine requirement determined using IAAO in adult men changes if the length of time on the personalized diets increases from 3 days to 5 and 9 days.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Length of Adaptation on Threonine Requirement in Healthy Adult Men
Actual Study Start Date : September 28, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Threonine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Healthy adult men

Participants will initially be seen for a pre-study assessment (2 hours). They will then be studied for up to 6 times (6 different levels of threonine intake). Each set of experiments will be 9-days in length. During the first 2 days, a pre-adaptation (milkshake) diet will be consumed. For the remaining 7 days, a protein liquid drink and protein-free cookies will be consumed. All of the diets will be provided by the investigators.

During each 9-day experiment, participants are expected to come to the Clinical Research Centre at the Hospital for Sick Children for breath and urine collection (5 hours total for each visit)

 Other: Dietary Intakes
6 levels of threonine intake will be provided by the protein liquid drink


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Determination of threonine requirement in young adult men after 8 hours, 3, and 7 days of adaptation to experimental diets. [ Time Frame: 3 years ]
    The threonine requirement will be determined using IAAO and breakpoint analysis after 3 different lengths of adaptation to the experimental diet


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult men, 19 to 35 years of age
  • Willingness to participate in the study and completed the screening procedures (height, weight, fasting blood sample and medical history questionnaire).
  • No recent history of weight loss
  • BMI between 18.5 - 27 kg/m 2
  • Absence of chronic disease or acute illness that could affect protein and AA metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications).
  • Non-smoking
  • Willingness to consume the diet provided for 9 days

Exclusion Criteria:

  1. Presence of disease known to affect protein and AA metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications).
  2. On medications known to affect protein and amino acid metabolism (steroids).
  3. Recent significant weight loss. ≥ 5% of body with in the last 3 months.
  4. Individuals on weight reducing diets.
  5. Inability to tolerate the diet
  6. Unwilling to have blood drawn from a venous access, or using a ventilated hood indirect calorimeter for the purposes of the study.
  7. Significant coffee consumption of more than 2 cups/day
  8. Significant alcohol consumption of more than one drink/day
  9. Failure to disclose any of the information needed to assess eligibility.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04585087


Contacts
Layout table for location contacts
Contact: Sylwia Szwiega, Phd(c) 416-813-7454 ext 307454 sylwia.szwiega@sickkids.ca
Contact: Mahroukh Rafii, BSc 416-813-7454 ext 307454 mahroukh.rafii@sickkids.ca

Locations
Layout table for location information
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Sylwia Szwiega, PhD    416-813-7654 ext 307454    Sylwia.szwiega@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Layout table for investigator information
Principal Investigator: Glenda Courtney-Martin, PhD The Hospital for Sick Children
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Glenda Courtney-Martin, Health Systems Research Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT04585087    
Other Study ID Numbers: 1000071242
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Glenda Courtney-Martin, The Hospital for Sick Children:
Healthy
Adult
Men
Threonine
Dietary Requirement