Protein/Amino Acid MetabolismHPINCT03845569
Influence of Habitual Protein Intake on AA Tracer Oxidation
A study testing Dietary protein intake reduction in people with Protein/Amino Acid Metabolism and Indicator Amino Acid Oxidation Method, run by University of Toronto at 1 site in Canada.
Trial summary
Protein is an essential nutrient that one's diet to maintain important bodily functions and to recover from exercise. Currently, the Indicator Amino Acid Oxidation method (IAAO) has been used to determine protein requirements in a variety of populations including children, neonates, the elderly and recently… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Protein/Amino Acid Metabolism, Indicator Amino Acid Oxidation Method
- What is being tested?
- Dietary protein intake reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2017to 18 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, weight-trained individuals that have trained consistently for > 1 year
- Habitually dietary protein consumption of 1.9 to 3.0g/kg/d
- Train each muscle group (i.e. chest, back, legs) at least twice a week
- Body mass stable in the last month
- Meets strength relative-to-weight guidelines (adapted from Morton et al., 2016; Chilibeck et -al., 1997)
- Bench Press: - Bodyweight (kg) * 1.25
- Leg Press: - Bodyweight (kg) *4.0
Who cannot join
- Inability to meet health and PA guidelines according to the PAR-Q+
- Inability to adhere to any of the protocol guidelines (e.g. alcohol and caffeine consumption)
- Regular tobacco use, screened by questionnaire
- Illicit drug use (e.g. growth hormone, testosterone, etc.), screened by a survey in training log
- 1 month sedentary in the last 6 months prior to study participation
- 30 minutes of continuous cardio per exercise session
Show all 9Show fewer
- BMI > or equal to 35
- Individual plans to increase or decrease body mass in the next 3 months
- Use of supplements (excluding whey protein), such as creatine and beta-alanine, in the last 30 days
Trial locations and contacts
1 site in 1 country.
Canada1 site
Goldring Centre for High Performance Sport
Toronto, Ontario, M5S 2C9
About this study
Official title: Impact of Habitual Protein Intake on Estimates of Dietary Protein Requirements in Resistance Trained Athletes
Protein is an essential nutrient that one's diet to maintain important bodily functions and to recover from exercise. Currently, the Indicator Amino Acid Oxidation method (IAAO) has been used to determine protein requirements in a variety of populations including children, neonates, the elderly and recently, resistance trained populations. This study serves to test the robustness of the IAAO method and to determine if high habitual dietary protein intake, as seen in resistance trained males, has the potential to influence the protein requirements determined by the IAAO method. Further, the current study also aims to determine how the body metabolizes or uses dietary protein and how it might change when consuming a protein intake that is less than what is habitually consumed.
Read the detailed description
This study employed a two-phase randomized crossover design, where participants performed both a High/Habitual protein phase and a moderate protein phase. The Habitual protein phase is designed to model resistance trained individual's habitual protein consumption by providing 2.2g/kg/d in a controlled diet. The Moderate protein phase is designed to investigate the impact of decreasing dietary protein intake to a moderate amount (1.2g/kg/d) over five days on protein metabolism. Both phases used the stable isotope L-[1-13C]Phenylalanine and metabolic trails were modelled after the indicator amino acid oxidation (IAAO) technique.
High Protein Phase The high protein phase is three days in length, with diet-controlled throughout, and a metabolic trail on day 3. Participants will perform whole-body resistance exercise on days one and three.
Moderate protein phase The Moderate protein phase is seven days in length, with MT on days three, five and seven. Dietary intake will be controlled throughout the whole phase providing either 2.2 g/kg/d of protein (days one and two), or 1.2 g/kg/d (days three through seven). Full body resistance exercise will be performed performed on days one, three, five and seven.
This phase will allow measurement of protein metabolism over five days following a decrease in dietary protein intake, and to determine the effect of dietary changes on the IAAO method.
- Being tested
- Dietary protein intake reduction, Three day Controlled Diet
- Keywords
- Amino acids, Protein, metabolism, IAAO, Tracer, Indicator amino acid, Resistance trained
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary protein intake reductionOther
Following two days of controlled diet at 2.2g/kg/d of dietary protein, intake was reduced to 1.2g/kg/d for five days, and protein metabolism was measured on days 1, 3, and 5.
Three day Controlled DietOther
Three days of a controlled diet providing 2.2g/kg/d of dietary protein with protein metabolism measured on day 3. This was used to model the habitual intake of this cohort.
| Study group | Role | What they receive |
|---|---|---|
| Habitual Protein phase | Other | A trial investigating protein oxidation/metabolism that was used to model resistance trained individual's habitual dietary protein intake (2.2g/kg/d). Receives: Other: Three day Controlled Diet |
| Moderate Protein Phase | Experimental | A series of three trials over a one week period investigating protein oxidation/metabolism that was used to investigate the metabolic response of decreased protein intake (1.2g/kg/d) over a period of five days (trials on days 1, 3, 5 following reduction in protein intake from 2.2g/kg/d to 1.2g/kg/d) relative to the Habitual protein phase trial. Receives: Other: Dietary protein intake reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenylalanine excretion (F13CO2)
Expressed as µmol/kg/h; phenylalanine excretion is determined via breath enrichment (F13CO2) of the oral tracer. Breath 13CO2 enrichment was measured by continuous-flow isotope ratio mass spectrometry
Measured: Through study completion, an average of 3 months
Phenylalanine oxidation (PheOX)
Expressed as µmol/kg/h; phenylalanine excretion is determined via breath and urine enrichment of the oral tracer. Breath 13CO2 enrichment was measured by continuous-flow isotope ratio mass spectrometry and urinary L-[1-13C] phenylalanine was measured by liquid chromatography tandem mass spectrometry
Measured: Through study completion, an average of 3 months
Secondary outcomes (2)
Phenylalanine Rate of Appearance (PheRa/Flux)
In µmol/kg/h; phenylalanine rate of appearance is determined via urinary enrichment of the oral tracer by liquid chromatography tandem mass spectrometry.
Measured: Through study completion, an average of 3 months
Net Protein Balance
In µmol/kg/h; calculated as the difference between whole-body protein synthesis and protein breakdown. ). Breath 13CO2 enrichment was measured by continuous-flow isotope ratio mass spectrometry and urinary L-[1-13C] phenylalanine was measured by liquid chromatography tandem mass spectrometry.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start1 Nov 2017
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Protein/Amino Acid MetabolismStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover trial.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Moore, University of Toronto
- Investigators
- Daniel R Moore, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845569
- Sponsor's protocol ID
- HPI
- Acronym
- HPI
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tinline-Goodfellow CT, West DWD, Malowany JM, Gillen JB, Moore DR. An Acute Reduction in Habitual Protein Intake Attenuates Post Exercise Anabolism and May Bias Oxidation-Derived Protein Requirements in Resistance Trained Men. Front Nutr. 2020 Apr 22;7:55. doi: 10.3389/fnut.2020.00055. eCollection 2020.
PubMed 32391374
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Habitual Protein Intake on Estimates of Dietary Protein Requirements in Resistance Trained Athletes
- ClinicalTrials.gov ID
- NCT03845569
- Acronym / sponsor ID
- HPI / HPI
- Keywords
- Amino acids, Protein, metabolism, IAAO, Tracer, Indicator amino acid, Resistance trained
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Protein is an essential nutrient that one's diet to maintain important bodily functions and to recover from exercise. Currently, the Indicator Amino Acid Oxidation method (IAAO) has been used to determine protein requirements in a variety of populations including children, neonates, the elderly and recently, resistance trained populations. This study serves to test the robustness of the IAAO method and to determine if high habitual dietary protein intake, as seen in resistance trained males, has the potential to influence the protein requirements determined by the IAAO method. Further, the current study also aims to determine how the body metabolizes or uses dietary protein and how it might change when consuming a protein intake that is less than what is habitually consumed.
Detailed description
This study employed a two-phase randomized crossover design, where participants performed both a High/Habitual protein phase and a moderate protein phase. The Habitual protein phase is designed to model resistance trained individual's habitual protein consumption by providing 2.2g/kg/d in a controlled diet. The Moderate protein phase is designed to investigate the impact of decreasing dietary protein intake to a moderate amount (1.2g/kg/d) over five days on protein metabolism. Both phases used the stable isotope L-[1-13C]Phenylalanine and metabolic trails were modelled after the indicator amino acid oxidation (IAAO) technique.
High Protein Phase The high protein phase is three days in length, with diet-controlled throughout, and a metabolic trail on day 3. Participants will perform whole-body resistance exercise on days one and three.
Moderate protein phase The Moderate protein phase is seven days in length, with MT on days three, five and seven. Dietary intake will be controlled throughout the whole phase providing either 2.2 g/kg/d of protein (days one and two), or 1.2 g/kg/d (days three through seven). Full body resistance exercise will be performed performed on days one, three, five and seven.
This phase will allow measurement of protein metabolism over five days following a decrease in dietary protein intake, and to determine the effect of dietary changes on the IAAO method.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover trial.
| Arm | Type | Receives |
|---|---|---|
| Habitual Protein phase | Other | Other: Three day Controlled DietA trial investigating protein oxidation/metabolism that was used to model resistance trained individual's habitual dietary protein intake (2.2g/kg/d). |
| Moderate Protein Phase | Experimental | Other: Dietary protein intake reductionA series of three trials over a one week period investigating protein oxidation/metabolism that was used to investigate the metabolic response of decreased protein intake (1.2g/kg/d) over a period of five days (trials on days 1, 3, 5 following reduction in protein intake from 2.2g/kg/d to 1.2g/kg/d) relative to the Habitual protein phase trial. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy, weight-trained individuals that have trained consistently for > 1 year
- Habitually dietary protein consumption of 1.9 to 3.0g/kg/d
- Train each muscle group (i.e. chest, back, legs) at least twice a week
- Body mass stable in the last month
- Meets strength relative-to-weight guidelines (adapted from Morton et al., 2016; Chilibeck et -al., 1997)
Key exclusion criteria (9 listed)
- Inability to meet health and PA guidelines according to the PAR-Q+
- Inability to adhere to any of the protocol guidelines (e.g. alcohol and caffeine consumption)
- Regular tobacco use, screened by questionnaire
- Illicit drug use (e.g. growth hormone, testosterone, etc.), screened by a survey in training log
- BMI > or equal to 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary protein intake reductionFollowing two days of controlled diet at 2.2g/kg/d of dietary protein, intake was reduced to 1.2g/kg/d for five days, and protein metabolism was measured on days 1, 3, and 5. | Other | Moderate Protein Phase |
| Three day Controlled DietThree days of a controlled diet providing 2.2g/kg/d of dietary protein with protein metabolism measured on day 3. This was used to model the habitual intake of this cohort. | Other | Habitual Protein phase |
Primary outcome
Phenylalanine excretion (F13CO2)
Time frame: Through study completion, an average of 3 months
Expressed as µmol/kg/h; phenylalanine excretion is determined via breath enrichment (F13CO2) of the oral tracer. Breath 13CO2 enrichment was measured by continuous-flow isotope ratio mass spectrometry
Phenylalanine oxidation (PheOX)
Time frame: Through study completion, an average of 3 months
Expressed as µmol/kg/h; phenylalanine excretion is determined via breath and urine enrichment of the oral tracer. Breath 13CO2 enrichment was measured by continuous-flow isotope ratio mass spectrometry and urinary L-[1-13C] phenylalanine was measured by liquid chromatography tandem mass spectrometry
2 secondary outcomes
Phenylalanine Rate of Appearance (PheRa/Flux)
Time frame: Through study completion, an average of 3 months
Net Protein Balance
Time frame: Through study completion, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Derived from this study: PubMed 32391374Tinline-Goodfellow CT, West DWD, Malowany JM, Gillen JB, Moore DR. An Acute Reduction in Habitual Protein Intake Attenuates Post Exercise Anabolism and May Bias Oxidation-Derived Protein Requirements in Resistance Trained Men. Front Nutr. 2020 Apr 22;7:55. doi: 10.3389/fnut.2020.00055. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel R Moore, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary protein intake reduction in people with Protein/Amino Acid Metabolism and Indicator Amino Acid Oxidation Method, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenylalanine excretion (F13CO2) (time frame: Through study completion, an average of 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03845569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.