- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03397043
Protein Requirements in Resistance Trained Females
March 28, 2019 updated by: Daniel Moore, University of Toronto
In this study, the investigators will use the minimally invasive indicator amino acid oxidation (IAAO) technique to determine protein requirements in weight-trained males.
It is hypothesized that the present study will show that protein requirements for weight-trained females are i) greater than the current RDA for non-active individual's comparable estimates, and ii) greater than existing nitrogen balance-based estimates for weight-training individuals
Study Overview
Detailed Description
Provided that energy needs are met, the adequate ingestion of dietary amino acids is the most critical nutritional factor to support the optimal remodeling and deposition of lean body mass in individuals of all ages.
Current recommendations according to the World Health Organization/Food and Agricultural Organization suggest that daily protein requirements in healthy, non-active adults are 0.8 g/kg/day.
However, of primary interest in the present study is the impact that exercise has on the nutritional requirement for dietary amino acids in highly active adults - e.g., individuals performing weight training.
Protein requirements for individuals who participate in strength-based exercise training have been suggested to range from 1.2-1.7g
protein/kg/day (Rodriguez et al., 2009; Tarnopolsky, 1992; Phillips et al., 2007), which equates to a 50-112% increase from the current RDA.
The increased requirement in this population may reflect the requirement for protein to repair/rebuild lean tissues by promoting anabolism (Phillips, 2004).
Nutritional requirements for dietary amino acids in adults (both active and non-active) have traditionally been determined utilizing the antiquated and often erroneous nitrogen balance technique (Costaneda et al., 1995; Campbell et al., 1984), which is prone to underestimating protein requirements and therefore provides challenges to making accurate nutritional recommendations (Humayun, Elango, Ball, and Pencharz, 2007).
This observation that nitrogen balance underestimates protein requirements in non-active individuals could suggest that protein requirements are much greater than the current WHO/FAO recommendation of 0.8 g/kg/day which was evaluated using the nitrogen balance technique (Rand, Pellett and Young, 2003).
As a result, there is a need to re-evaluate recommendations utilizing advanced stable isotope methodology in order to characterize how dietary amino acid needs may be modulated by physical activity.
Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than WHO/FAO guidelines based on nitrogen balance data (Humayun, Elango, Ball, and Pencharz, 2007).
Furthermore, resistance training has been reported to increase (according to nitrogen balance methodology) protein requirements by up to 75% Tarnopolsky et al., 1992).
Therefore, in this study, the investigators will use the IAAO technique to determine protein requirements in weight-trained males.
It is hypothesized that the present study will show that protein requirements for weight-trained females are i) greater than the current RDA for non-active individual's comparable estimates, and ii) greater than existing nitrogen balance-based estimates for weight-training individuals.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- healthy female weight-trained individuals that have trained consistently for >1 year
- complete a physical activity readiness questionnaire (PAR-Q+)
- Train each muscle group (i.e. chest, back, legs) at least twice a week
- Meets strength relative to body weight GUIDELINES adapted from Morton et al., 2016; Chilibeck et al., 1997 (sex specific).
Bench Press:
body weight (kg)*0.7
Leg Press:
body weight (kg)*2.3
Exclusion Criteria:
- sedentary for greater than 1 month in the last 6 months prior to the study
- non-weight stable for the past month
- smoker
- Illicit drug use (e.g. growth hormone, testosterone, etc.)
- Individual plans to increase or decrease body mass in the next 3 months
- Habitually ingests greater than or equal to 3g protein kg/bw/day
- Use of supplements such as creatine and beta-alanine in the last 30 days.
- Hormone-based birth control. Hormonal fluctuations associated with the menstrual cycle have been reported to alter protein metabolism during exercise (Hamadeh, Devries, and Tarnopolsky, 2005) For this reason, the following exclusion criteria will be applied to female participants only: use of birth control and discontinued use within last 3 months
- Inability to adhere to any of the protocol guidelines
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy females
All participants receive the intervention: Protein intake (dose).
This consists of varying levels of dietary protein intakes, in the form of crystalline amino acids, ranging from 0.2-3.0
g/kg/d
|
Protein intake, in the form of crystalline amino acids, will range between 0.2-3.0
g/kg/d
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phenylalanine oxidation
Time Frame: Through study completion: an average of 6 metabolic trials (days), each separated by approximately 1 week
|
In µmol/kg/h, the product of F13CO2 and VCO2.
F13CO2 is determined via breath enrichment analysis of 13CO2 after 1-13C phenylalanine ingestion, and VCO2 is determined via indirect calorimetry
|
Through study completion: an average of 6 metabolic trials (days), each separated by approximately 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phenylalanine rate of appearance
Time Frame: Through study completion: an average of 6 metabolic trials (days), each separated by approximately 1 week
|
In µmol/kg/h; calculated from urine analysis of1-13C Phe enrichment
|
Through study completion: an average of 6 metabolic trials (days), each separated by approximately 1 week
|
|
Net protein balance
Time Frame: Through study completion: an average of 6 metabolic trials (days), each separated by approximately 1 week
|
In µmol/kg/h; calculated as the difference between whole body net protein synthesis and protein breakdown
|
Through study completion: an average of 6 metabolic trials (days), each separated by approximately 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Actual)
October 6, 2017
Study Completion (Actual)
November 30, 2018
Study Registration Dates
First Submitted
January 5, 2018
First Submitted That Met QC Criteria
January 5, 2018
First Posted (Actual)
January 11, 2018
Study Record Updates
Last Update Posted (Actual)
March 29, 2019
Last Update Submitted That Met QC Criteria
March 28, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- RTF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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