Clinical trial · Interventional
Length of Adaptation and Threonine Requirement
The Effect of Length of Adaptation on Threonine Requirement in Healthy Adult Men
NCT04585087CI-TRIAL-00061735completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary Intakes | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Healthy adult men
- description
- 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)
- interventionNames
- Other: Dietary Intakes
Primary outcomes (1)
- measure
- Determination of threonine requirement in young adult men after 8 hours, 3, and 7 days of adaptation to experimental diets.
- timeFrame
- 3 years
- description
- The threonine requirement will be determined using IAAO and breakpoint analysis after 3 different lengths of adaptation to the experimental diet
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSzwiega S, Pencharz PB, Ball RO, Xu L, Kong D, Elango R, Courtney-Martin G. Length of Adaptation Has No Effect on the Threonine Requirement Determined in Healthy Young Adult Males Using the Indicator Amino Acid Oxidation Method. J Nutr. 2023 Jul;153(7):2016-2026. doi: 10.1016/j.tjnut.2023.03.033. Epub 2023 Mar 31. PMID 37004875