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HealthyNCT03397043

Protein Requirements in Resistance Trained Females

A study testing Protein intake (dose) in people with Healthy, run by University of Toronto.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 groups in NCT03397043
Study groupRoleWhat they receive
Healthy femalesExperimentalAll 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted11 Jan 2018
  2. Study start1 Nov 2016
  3. Primary completion6 Oct 2017
  4. Study completion30 Nov 2018

Resources

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)
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

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.

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