HealthyNCT03696264
Protein Requirements in Resistance-trained Males
A study testing Amino acid intake in people with Healthy, run by University of Toronto at 1 site in Canada.
Trial summary
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… 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
- Healthy
- What is being tested?
- Amino acid intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 6 Mar 2017to 31 Oct 2017
- 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, 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:
Show all 9Show fewer
- Males- body weight (kg)1.25
- Leg Press:
- Males- body weight (kg) 4.0
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Goldring Centre for High Performance Sport
Toronto, Ontario, M5S2C9
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Amino acid intake
- Keywords
- Protein Requirements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino acid intakeDietary supplement
Amino acid intake will range between 0.2-3.0g/kg/d
| Study group | Role | What they receive |
|---|---|---|
| Resistance-trained, adult males | Experimental | Subjects receive varying levels of amino acid intakes ranging from 0.2-3.0g/kg/d Receives: Dietary Supplement: Amino acid intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenylalanine excretion
Expressed as µmol/kg/h; phenylalanine excretion is determined via breath enrichment of the oral tracer
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Phenylalanine rate of appearance
In µmol/kg/h; phenylalanine rate of appearance is determined via urinary enrichment of the oral tracer
Measured: Through study completion, an average of 1 year
Net Protein Balance
In µmol/kg/h; calculated as the difference between whole-body protein synthesis and protein breakdown
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start6 Mar 2017
- Primary completion1 Jul 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 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
- NCT03696264
- Sponsor's protocol ID
- RTM
- Status last verified
- Oct 2018
- First submitted
- 1 Oct 2018
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 26920240Phillips 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.
PubMed 15212752Rand 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.
PubMed 12499330Humayun 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.
PubMed 17921376Tarnopolsky 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.
PubMed 1474076Mazzulla 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.
PubMed 31618421
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Requirements in Resistance-trained Males
- ClinicalTrials.gov ID
- NCT03696264
- Acronym / sponsor ID
- RTM
- Conditions
- Healthy
- Keywords
- Protein Requirements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 4 Oct 2018 (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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistance-trained, adult males | Experimental | Dietary Supplement: Amino acid intakeSubjects receive varying levels of amino acid intakes ranging from 0.2-3.0g/kg/d |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Amino acid intakeAmino acid intake will range between 0.2-3.0g/kg/d | Dietary supplement | Resistance-trained, adult males |
Primary outcome
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
2 secondary outcomes
Phenylalanine rate of appearance
Time frame: Through study completion, an average of 1 year
Net Protein Balance
Time frame: Through study completion, an average of 1 year
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 4 Oct 2018.
- Background: PubMed 26920240Thomas 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.
- Background: PubMed 15212752Phillips 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.
- Background: PubMed 12499330Rand 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.
- Background: PubMed 17921376Humayun 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.
- Background: PubMed 1474076Tarnopolsky 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.
- Derived from this study: PubMed 31618421Mazzulla 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.
- Individual participant dataSharing planned: Undecided
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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 Amino acid intake in people with Healthy, 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 9 inclusion and 10 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 4 Oct 2018. 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 (time frame: Through study completion, an average of 1 year). 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 NCT03696264, which also lists 6 linked publications.
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 4 Oct 2018.