Muscle Protein SynthesisNCT02282566
Effect of Protein-nutrition Beverages on Muscle Protein Synthesis in Women
A study testing Protein-nutrition beverage in people with Muscle Protein Synthesis, run by PepsiCo Global R&D at 1 site in Canada.
Trial summary
This study investigates whether a protein-nutrition beverage can increase muscle protein synthesis to a similar magnitude as a control beverage. Read more about this study
- Who is it for?
- Ages 65 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Protein Synthesis
- What is being tested?
- Protein-nutrition beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jan 2015to 30 Mar 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 65 to 75 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Older women, 65 to 75 years of age
- At least 5 years post-menopausal
- Body mass index (BMI) 20.00-29.99 kg/m2
- Maintenance of habitual diet, physical activity patterns, and body weight throughout the trial
- Low to moderate habitual physical activity ( > 3500 but < 10,000 steps/d, no structured activity)
- In general good health (stage I hypertension allowed - 140/90) on the basis of medical history; and taking no medication other than anti-hypertensives, selective serotonin-reuptake inhibitors, and/or statins (excluding simvastatin [Zocor] and atorvastatin [Lipitor])
- Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
- Participant can consume a protein drink in the allotted time frame of 10 minutes
Who cannot join
- History or presence of clinically important renal or gastrointestinal disorders, diabetes mellitus (glucose >126 mg/dL, fingerstick) or metabolic disease, unstable arrhythmia, angina, taking anti-diabetic, anti-inflammatory, platelet inhibitor, or anti-coagulant medications.
- Vegan
- Smoker
- Overt osteoporosis and/or osteopenia and/or sarcopenia as determined by DXA
- High physical activity or participating in regular structured exercise (> 10,000 steps/d)
- History of allergy, sensitivity, or strong dislike towards any of the components of the study products (dairy protein)
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- Use of an investigational drug product within the last 30 days
- Having participated in an another infusion protocol in the past year
- Individual has a condition the PI believes would interfere with her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk
- Subject does not understand English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Trial to Assess the Effect of a Protein-Nutrition Beverage on Skeletal Muscle Protein Synthesis in Women
This study investigates whether a protein-nutrition beverage can increase muscle protein synthesis to a similar magnitude as a control beverage.
Read the detailed description
Potential participants will be screened, and if eligible, invited to participate. Body composition and physical activity level will be assessed during the initiation visit. During the trial visits, women receive a protein-nutrition beverage; muscle protein synthesis is assessed via blood analytes and muscle biopsies at rest and after exercise. Statistical analysis includes mixed model regression approach with change in muscle protein synthesis as the primary outcome.
- Conditions
- Muscle Protein Synthesis
- Being tested
- Protein-nutrition beverage
- Keywords
- Muscle protein synthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein-nutrition beverageOther
Intervention involves consumption of one protein-nutrition beverage after exercise bout and 2 times per day for 5 days thereafter
| Study group | Role | What they receive |
|---|---|---|
| Protein-nutrition beverage - Placebo | Placebo comparator | : 8 oz protein-nutrition beverage 1 Receives: Other: Protein-nutrition beverage |
| Protein-nutrition beverage - Beverage 2 | Experimental | 8 oz protein-nutrition beverage 2 Receives: Other: Protein-nutrition beverage |
| Protein-nutrition beverage - Beverage 3 | Experimental | 8 oz protein-nutrition beverage 3 Receives: Other: Protein-nutrition beverage |
| Protein-nutrition beverage - Beverage 4 | Experimental | 8 oz protein-nutrition beverage 4 Receives: Other: Protein-nutrition beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (timei -baseline) of muscle protein synthesis at rest and following exercise in response to the protein-nutrition beverages compared to a control beverage
Measured: 0-3 hours post consumption and 5 days post consumptions
Secondary outcomes (1)
Change (timei -baseline) of blood sample analytes at rest and following exercise in response to the protein-nutrition beverages compared to a control beverage
Measured: 0-3 hours post consumption and 5 days post consumptions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study start6 Jan 2015
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle Protein SynthesisStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Philips, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282566
- Sponsor's protocol ID
- PEP-1331
- Status last verified
- Mar 2021
- First submitted
- 30 Oct 2014
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Devries MC, McGlory C, Bolster DR, Kamil A, Rahn M, Harkness L, Baker SK, Phillips SM. Leucine, Not Total Protein, Content of a Supplement Is the Primary Determinant of Muscle Protein Anabolic Responses in Healthy Older Women. J Nutr. 2018 Jul 1;148(7):1088-1095. doi: 10.1093/jn/nxy091.
PubMed 29901760Devries MC, McGlory C, Bolster DR, Kamil A, Rahn M, Harkness L, Baker SK, Phillips SM. Protein leucine content is a determinant of shorter- and longer-term muscle protein synthetic responses at rest and following resistance exercise in healthy older women: a randomized, controlled trial. Am J Clin Nutr. 2018 Feb 1;107(2):217-226. doi: 10.1093/ajcn/nqx028.
PubMed 29529146
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial to Assess the Effect of a Protein-Nutrition Beverage on Skeletal Muscle Protein Synthesis in Women
- ClinicalTrials.gov ID
- NCT02282566
- Acronym / sponsor ID
- PEP-1331
- Conditions
- Muscle Protein Synthesis
- Keywords
- Muscle protein synthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2015 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 4 Nov 2014 (estimated)
- 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 investigates whether a protein-nutrition beverage can increase muscle protein synthesis to a similar magnitude as a control beverage.
Detailed description
Potential participants will be screened, and if eligible, invited to participate. Body composition and physical activity level will be assessed during the initiation visit. During the trial visits, women receive a protein-nutrition beverage; muscle protein synthesis is assessed via blood analytes and muscle biopsies at rest and after exercise. Statistical analysis includes mixed model regression approach with change in muscle protein synthesis as the primary outcome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Protein-nutrition beverage - Placebo | Placebo comparator | Other: Protein-nutrition beverage: 8 oz protein-nutrition beverage 1 |
| Protein-nutrition beverage - Beverage 2 | Experimental | Other: Protein-nutrition beverage8 oz protein-nutrition beverage 2 |
| Protein-nutrition beverage - Beverage 3 | Experimental | Other: Protein-nutrition beverage8 oz protein-nutrition beverage 3 |
| Protein-nutrition beverage - Beverage 4 | Experimental | Other: Protein-nutrition beverage8 oz protein-nutrition beverage 4 |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Older women, 65 to 75 years of age
- At least 5 years post-menopausal
- Body mass index (BMI) 20.00-29.99 kg/m2
- Maintenance of habitual diet, physical activity patterns, and body weight throughout the trial
- Low to moderate habitual physical activity ( > 3500 but < 10,000 steps/d, no structured activity)
Key exclusion criteria (10 listed)
- History or presence of clinically important renal or gastrointestinal disorders, diabetes mellitus (glucose >126 mg/dL, fingerstick) or metabolic disease, unstable arrhythmia, angina, taking anti-diabetic, anti-inflammatory, platelet inhibitor, or anti-coagulant medications.
- Vegan
- Smoker
- Overt osteoporosis and/or osteopenia and/or sarcopenia as determined by DXA
- High physical activity or participating in regular structured exercise (> 10,000 steps/d)
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-nutrition beverageIntervention involves consumption of one protein-nutrition beverage after exercise bout and 2 times per day for 5 days thereafter | Other | Protein-nutrition beverage - Beverage 2, Protein-nutrition beverage - Beverage 3, Protein-nutrition beverage - Beverage 4, Protein-nutrition beverage - Placebo |
Primary outcome
Change (timei -baseline) of muscle protein synthesis at rest and following exercise in response to the protein-nutrition beverages compared to a control beverage
Time frame: 0-3 hours post consumption and 5 days post consumptions
1 secondary outcome
Change (timei -baseline) of blood sample analytes at rest and following exercise in response to the protein-nutrition beverages compared to a control beverage
Time frame: 0-3 hours post consumption and 5 days post consumptions
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 2021.
- Derived from this study: PubMed 29901760Devries MC, McGlory C, Bolster DR, Kamil A, Rahn M, Harkness L, Baker SK, Phillips SM. Leucine, Not Total Protein, Content of a Supplement Is the Primary Determinant of Muscle Protein Anabolic Responses in Healthy Older Women. J Nutr. 2018 Jul 1;148(7):1088-1095. doi: 10.1093/jn/nxy091.
- Derived from this study: PubMed 29529146Devries MC, McGlory C, Bolster DR, Kamil A, Rahn M, Harkness L, Baker SK, Phillips SM. Protein leucine content is a determinant of shorter- and longer-term muscle protein synthetic responses at rest and following resistance exercise in healthy older women: a randomized, controlled trial. Am J Clin Nutr. 2018 Feb 1;107(2):217-226. doi: 10.1093/ajcn/nqx028.
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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.
Stuart Philips, PhD principal investigator
McMaster University
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-nutrition beverage in people with Muscle Protein Synthesis, run by PepsiCo Global R&D 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 8 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 10 Mar 2021. 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?
Change (timei -baseline) of muscle protein synthesis at rest and following exercise in response to the protein-nutrition beverages compared to a control beverage (time frame: 0-3 hours post consumption and 5 days post consumptions). 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 NCT02282566, which also lists 2 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 10 Mar 2021.