- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03845569
Influence of Habitual Protein Intake on AA Tracer Oxidation (HPI)
Impact of Habitual Protein Intake on Estimates of Dietary Protein Requirements in Resistance Trained Athletes
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5S 2C9
- Goldring Centre for High Performance Sport
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Habitual Protein phase
A trial investigating protein oxidation/metabolism that was used to model resistance trained individual's habitual dietary protein intake (2.2g/kg/d).
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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.
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Experimental: Moderate Protein Phase
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Through study completion, an average of 3 months
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Phenylalanine oxidation (PheOX)
Time Frame: Through study completion, an average of 3 months
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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
|
Through study completion, an average of 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phenylalanine Rate of Appearance (PheRa/Flux)
Time Frame: Through study completion, an average of 3 months
|
In µmol/kg/h; phenylalanine rate of appearance is determined via urinary enrichment of the oral tracer by liquid chromatography tandem mass spectrometry.
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Through study completion, an average of 3 months
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Net Protein Balance
Time Frame: Through study completion, an average of 3 months
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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.
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Through study completion, an average of 3 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HPI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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