HealthyNCT03397043
Protein Requirements in Resistance Trained Females
A study testing Protein intake (dose) in people with Healthy, run by University of Toronto.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Protein intake (dose)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 30 Nov 2018
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
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
Read the 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.
- Conditions
- Healthy
- Being tested
- Protein intake (dose)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein intake (dose)Other
Protein intake, in the form of crystalline amino acids, will range between 0.2-3.0 g/kg/d
| Study group | Role | What they receive |
|---|---|---|
| Healthy females | Experimental | 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 Receives: Other: Protein intake (dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenylalanine oxidation
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
Measured: Through study completion: an average of 6 metabolic trials (days), each separated by approximately 1 week
Secondary outcomes (2)
Phenylalanine rate of appearance
In µmol/kg/h; calculated from urine analysis of1-13C Phe enrichment
Measured: Through study completion: an average of 6 metabolic trials (days), each separated by approximately 1 week
Net protein balance
In µmol/kg/h; calculated as the difference between whole body net protein synthesis and protein breakdown
Measured: Through study completion: an average of 6 metabolic trials (days), each separated by approximately 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start1 Nov 2016
- Primary completion6 Oct 2017
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 8 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
- NCT03397043
- Sponsor's protocol ID
- RTF
- Status last verified
- Mar 2019
- First submitted
- 5 Jan 2018
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Requirements in Resistance Trained Females
- ClinicalTrials.gov ID
- NCT03397043
- Acronym / sponsor ID
- RTF
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 6 Oct 2017 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 11 Jan 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 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
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy females | Experimental | Other: Protein intake (dose)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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
- body weight (kg)0.7
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Protein intake (dose)Protein intake, in the form of crystalline amino acids, will range between 0.2-3.0 g/kg/d | Other | Healthy females |
Primary outcome
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
2 secondary outcomes
Phenylalanine rate of appearance
Time frame: 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
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 29 Mar 2019.
- 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
Questions about this trial
What is this clinical trial studying?
A study testing Protein intake (dose) in people with Healthy, run by University of Toronto.
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 8 inclusion and 9 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 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 oxidation (time frame: Through study completion: an average of 6 metabolic trials (days), each separated by approximately 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2019.