- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03696264
Protein Requirements in Resistance-trained Males
October 2, 2018 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 resistance-trained males.
It is hypothesized that the present study will show that protein requirements for resistance-trained males are i) greater than the current recommended dietary allowance (RDA) for non-active individual's comparable estimates, and ii) greater than existing nitrogen balance-based estimates for resistance-training individuals.
Study Overview
Detailed Description
The adequate ingestion of dietary protein is the most critical nutritional factor to support the growth and maintenance of lean body mass across the lifespan.
Currently, the World Health Organization/Food and Agricultural Organization (WHO/FAO) 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 protein in habitually active adults (e.g., individuals performing chronic resistance training).
Protein requirements for individuals who participate in strength-based exercise training have been suggested to range from 1.2-1.7 g protein/kg/day (1), which equates to a 50-112% increase from the current RDA.
The increased requirement in strength training populations may reflect the requirement for protein to repair and/or rebuild muscle tissue by promoting anabolism (2).
Nutritional requirements for dietary protein in adults (both active and non-active) have traditionally been determined utilizing the antiquated and often erroneous nitrogen balance (NBAL) technique (3), which is prone to underestimating protein requirements and therefore provides challenges to making accurate nutritional recommendations (4).
This observation that NBAL underestimates protein requirements in non-active individuals could suggest that protein requirements are much greater than the current World Health Organization recommendation of 0.8 g/kg/day, which was evaluated using the NBAL technique (3).
As a result, there is a need to re-evaluate recommendations utilizing advanced stable isotope methodology in order to characterize how dietary protein 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 NBAL data (4).
Furthermore, resistance training has been reported to increase (according to NBAL methodology) protein requirements by up to 75% (6).
Therefore, in this study, the investigators will use the IAAO technique to determine protein requirements in resistance-trained males.
It is hypothesized that protein requirements for resistance-trained males will be i) greater than the current RDA for non-active individual's comparable estimates, and ii) greater than existing NBAL-based estimates for resistance-training individuals.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S2C9
- Goldring Centre for High Performance Sport
-
-
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
Male
Description
Inclusion Criteria:
- Healthy, male weight-trained individuals that have trained consistently for >1 year.
- 18-35 years old.
- Train each muscle group (i.e. chest, back, legs) at least twice a week.
- Body mass stable in last month
- Meets strength relative to body weight guidelines (see below)
Bench Press:
Males- body weight (kg)*1.25
Leg Press:
Males- body weight (kg)* 4.0
Exclusion Criteria:
- Inability to meet health and physical activity guidelines according to the Physical Activity Readiness Questionnaire
- Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
- Regular tobacco use
- Illicit drug use (e.g. growth hormone, testosterone, etc.) (screened by survey sheet for training log
- >1 month sedentary in the last 6 months prior to study participation
- >30 min of continuous cardio per exercise session
- BMI (Body Mass Index) > 35.
- 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.
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Resistance-trained, adult males
Subjects receive varying levels of amino acid intakes ranging from 0.2-3.0g/kg/d
|
Amino acid intake will range between 0.2-3.0g/kg/d
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phenylalanine excretion
Time Frame: Through study completion, an average of 1 year
|
Expressed as µmol/kg/h; phenylalanine excretion is determined via breath enrichment of the oral tracer
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phenylalanine rate of appearance
Time Frame: Through study completion, an average of 1 year
|
In µmol/kg/h; phenylalanine rate of appearance is determined via urinary enrichment of the oral tracer
|
Through study completion, an average of 1 year
|
|
Net Protein Balance
Time Frame: Through study completion, an average of 1 year
|
In µmol/kg/h; calculated as the difference between whole-body protein synthesis and protein breakdown
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Thomas DT, Erdman KA, Burke LM. Position of the Academy of Nutrition and Dietetics, Dietitians of Canada, and the American College of Sports Medicine: Nutrition and Athletic Performance. J Acad Nutr Diet. 2016 Mar;116(3):501-528. doi: 10.1016/j.jand.2015.12.006. Erratum In: J Acad Nutr Diet. 2017 Jan;117(1):146.
- Phillips SM. Protein requirements and supplementation in strength sports. Nutrition. 2004 Jul-Aug;20(7-8):689-95. doi: 10.1016/j.nut.2004.04.009.
- Rand WM, Pellett PL, Young VR. Meta-analysis of nitrogen balance studies for estimating protein requirements in healthy adults. Am J Clin Nutr. 2003 Jan;77(1):109-27. doi: 10.1093/ajcn/77.1.109.
- Humayun MA, Elango R, Ball RO, Pencharz PB. Reevaluation of the protein requirement in young men with the indicator amino acid oxidation technique. Am J Clin Nutr. 2007 Oct;86(4):995-1002. doi: 10.1093/ajcn/86.4.995.
- Tarnopolsky MA, Atkinson SA, MacDougall JD, Chesley A, Phillips S, Schwarcz HP. Evaluation of protein requirements for trained strength athletes. J Appl Physiol (1985). 1992 Nov;73(5):1986-95. doi: 10.1152/jappl.1992.73.5.1986.
- Mazzulla M, Abou Sawan S, Williamson E, Hannaian SJ, Volterman KA, West DWD, Moore DR. Protein Intake to Maximize Whole-Body Anabolism during Postexercise Recovery in Resistance-Trained Men with High Habitual Intakes is Severalfold Greater than the Current Recommended Dietary Allowance. J Nutr. 2020 Mar 1;150(3):505-511. doi: 10.1093/jn/nxz249.
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)
March 6, 2017
Primary Completion (ACTUAL)
July 1, 2017
Study Completion (ACTUAL)
October 31, 2017
Study Registration Dates
First Submitted
October 1, 2018
First Submitted That Met QC Criteria
October 2, 2018
First Posted (ACTUAL)
October 4, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 4, 2018
Last Update Submitted That Met QC Criteria
October 2, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RTM
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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