Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03845569
Other study ID # HPI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date April 18, 2018

Study information

Verified date February 2019
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date April 18, 2018
Est. primary completion date April 18, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Dietary protein intake reduction
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 Diet
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.

Locations

Country Name City State
Canada Goldring Centre for High Performance Sport Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Through study completion, an average of 3 months
Primary 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 Through study completion, an average of 3 months
Secondary 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. Through study completion, an average of 3 months
Secondary 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. Through study completion, an average of 3 months