Muscle Protein SynthesisAPRENCT04302038
The Effects Potato Protein on Rates of Myofibrillar Muscle Protein Synthesis in Young Women
A study testing Protein in people with Muscle Protein Synthesis, run by McMaster University at 1 site in Canada.
Trial summary
This study will investigate the effects of potato protein on muscle protein synthesis over a short-term (a few hours after eating) and longer term (after two weeks of unilateral resistance exercise). Young women will be randomized to received potato protein supplementation or placebo in addition to their usual diet. Read more about this study
- Who is it for?
- Ages 18 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Protein Synthesis
- What is being tested?
- Protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2018to 6 Jun 2019
- 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 29 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- meet the age requirements
- Female sex
Who cannot join
- Significant loss or gain of body mass in the past 6 months (>2 kg)
- Regular use of: non-steroidal anti-inflammatory drugs
- History of chronic disease
- Current or recently active or remised cancer
- Infectious disease; and/or gastrointestinal disease
- Consuming a vegetarian or vegan diet = Any condition or injury that would preclude them from participating in resistance exercise
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate the effects of potato protein on muscle protein synthesis over a short-term (a few hours after eating) and longer term (after two weeks of unilateral resistance exercise). Young women will be randomized to received potato protein supplementation or placebo in addition to their usual diet. Muscle biopsies will be taken and the participants will drink doubly labelled water to allow for the measurement of protein synthesis over time.
Read the detailed description
The loss of skeletal muscle mass and strength with advancing age, collectively termed sarcopenia, is a primary risk factor for disability, frailty, and premature mortality. This is especially true in women, where rapid rates of decline in muscle mass and greater anabolic resistance (blunting of muscle protein synthesis [MPS] despite availability of amino acids) are experienced around the time of menopause2. Previous evidence has demonstrated that resistance exercise is an effective strategy to mitigate muscle loss in older adults, particularly in conjunction with protein supplementation. Typically, animal-based proteins are utilized in research studies; however, they may be inaccessible for older women with limited financial income or simply unattractive to the growing number of women consuming more plant-based diets. While potatoes contain lower amounts of protein compared to animal sources, the high biological value (BV~90-100) of potato protein and high consumption rates, make this food an ideal source of protein in North American diets. In fact, potatoes contribute roughly 3%-3.5% of the total daily protein intake for adults and plant-based proteins contribute 60% of dietary protein worldwide. When compared to animal sourced protein, potatoes are readily available and are a highly sustainable food source. Consequently, potatoes represent an accessible, cost-effective protein source for the growing aging population. However, the efficacy of a diet rich in potato protein to stimulate an increase in integrated rates of MPS, which are the basis for muscle growth, in women has not been investigated. Therefore, while the eventual target consumer will be all women, young and old, firstly we will demonstrate the effectiveness of potato based protein to stimulate MPS in young women.
Twenty-four healthy young women (18-29 yrs) will be recruited to participate in this parallel group, double blind, randomized controlled trial. Participants will be randomized to either supplementary isolated potato protein and unilateral resistance training, or unilateral resistance training alone as placebo (with usual dietary practices, protein clamped at 0.8 g/kg/day). Participants will engage in unilateral resistance training 3 times per wk for 2 wk. To assess the anabolic properties of potato protein, the women in the potato protein group will ingest 25 g of isolated potato protein 2 times a day. On the day of resistance exercise one serving will be provided immediately after the cessation of training. The placebo group will follow the same supplement schedule, but with a placebo. Integrated rates of myofibrillar MPS will be assessed with the precursor-product method using deuterium labeled water (70% D2O).
- Conditions
- Muscle Protein Synthesis
- Being tested
- Protein, Placebo control
- Keywords
- Potato Protein, Muscle protein synthesis, Young women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProteinDietary supplement
Additional daily protein provided by potato protein.
Placebo controlDietary supplement
No additional dietary protein (outside of 0.8 g/kg/day as provided by diet)
| Study group | Role | What they receive |
|---|---|---|
| Potato protein | Experimental | Participants will be provided with 25 g of potato protein twice per day in addition to a diet set at the recommended daily allowance. Total protein intake for this group will be 1.6 g/kg/day Receives: Dietary Supplement: Protein |
| Control group | Placebo comparator | This group will consume protein from food sources set at 0.8 /kg/day including 2 pudding placebo cups per day. Receives: Dietary Supplement: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis
Myofibrillar protein synthesis via measurement of deuterated (doubly) labeled water
Measured: 17 days
Secondary outcomes (1)
Protein expression
Western blot analysis to determine total protein expression of the proteins involved in the muscle protein synthesis pathway
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Nov 2018
- Primary completion6 Jun 2019
- Study completion6 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Protein SynthesisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group, single blind, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302038
- Sponsor's protocol ID
- HIREB 4969
- Acronym
- APRE
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Potato Protein on Rates of Myofibrillar Muscle Protein Synthesis in Young Women
- ClinicalTrials.gov ID
- NCT04302038
- Acronym / sponsor ID
- APRE / HIREB 4969
- Conditions
- Muscle Protein Synthesis
- Keywords
- Potato Protein, Muscle protein synthesis, Young women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 10 Mar 2020 (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.
This study will investigate the effects of potato protein on muscle protein synthesis over a short-term (a few hours after eating) and longer term (after two weeks of unilateral resistance exercise). Young women will be randomized to received potato protein supplementation or placebo in addition to their usual diet. Muscle biopsies will be taken and the participants will drink doubly labelled water to allow for the measurement of protein synthesis over time.
Detailed description
The loss of skeletal muscle mass and strength with advancing age, collectively termed sarcopenia, is a primary risk factor for disability, frailty, and premature mortality. This is especially true in women, where rapid rates of decline in muscle mass and greater anabolic resistance (blunting of muscle protein synthesis [MPS] despite availability of amino acids) are experienced around the time of menopause2. Previous evidence has demonstrated that resistance exercise is an effective strategy to mitigate muscle loss in older adults, particularly in conjunction with protein supplementation. Typically, animal-based proteins are utilized in research studies; however, they may be inaccessible for older women with limited financial income or simply unattractive to the growing number of women consuming more plant-based diets. While potatoes contain lower amounts of protein compared to animal sources, the high biological value (BV~90-100) of potato protein and high consumption rates, make this food an ideal source of protein in North American diets. In fact, potatoes contribute roughly 3%-3.5% of the total daily protein intake for adults and plant-based proteins contribute 60% of dietary protein worldwide. When compared to animal sourced protein, potatoes are readily available and are a highly sustainable food source. Consequently, potatoes represent an accessible, cost-effective protein source for the growing aging population. However, the efficacy of a diet rich in potato protein to stimulate an increase in integrated rates of MPS, which are the basis for muscle growth, in women has not been investigated. Therefore, while the eventual target consumer will be all women, young and old, firstly we will demonstrate the effectiveness of potato based protein to stimulate MPS in young women.
Twenty-four healthy young women (18-29 yrs) will be recruited to participate in this parallel group, double blind, randomized controlled trial. Participants will be randomized to either supplementary isolated potato protein and unilateral resistance training, or unilateral resistance training alone as placebo (with usual dietary practices, protein clamped at 0.8 g/kg/day). Participants will engage in unilateral resistance training 3 times per wk for 2 wk. To assess the anabolic properties of potato protein, the women in the potato protein group will ingest 25 g of isolated potato protein 2 times a day. On the day of resistance exercise one serving will be provided immediately after the cessation of training. The placebo group will follow the same supplement schedule, but with a placebo. Integrated rates of myofibrillar MPS will be assessed with the precursor-product method using deuterium labeled water (70% D2O).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel group, single blind, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Potato protein | Experimental | Dietary Supplement: ProteinParticipants will be provided with 25 g of potato protein twice per day in addition to a diet set at the recommended daily allowance. Total protein intake for this group will be 1.6 g/kg/day |
| Control group | Placebo comparator | Dietary Supplement: Placebo controlThis group will consume protein from food sources set at 0.8 /kg/day including 2 pudding placebo cups per day. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- meet the age requirements
- Female sex
Key exclusion criteria (6 listed)
- Significant loss or gain of body mass in the past 6 months (>2 kg)
- Regular use of: non-steroidal anti-inflammatory drugs
- History of chronic disease
- Current or recently active or remised cancer
- Infectious disease; and/or gastrointestinal disease
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 |
|---|---|---|
| ProteinAdditional daily protein provided by potato protein. | Dietary supplement | Potato protein |
| Placebo controlNo additional dietary protein (outside of 0.8 g/kg/day as provided by diet) | Dietary supplement | Control group |
Primary outcome
Muscle protein synthesis
Time frame: 17 days
Myofibrillar protein synthesis via measurement of deuterated (doubly) labeled water
1 secondary outcome
Protein expression
Time frame: 17 days
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 10 Mar 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein in people with Muscle Protein Synthesis, run by McMaster University 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 2 inclusion and 6 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 10 Mar 2020. 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. Some participants in this study may receive a placebo. 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?
Muscle protein synthesis (time frame: 17 days). 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 10 Mar 2020.