Muscle StrengthPhase 2NCT04814225
Investigation of the Efficacy and Safety of Three Test Products and Comparator on Muscular Performance After the Initiation of a Resistance Training Program
A Phase 2 study testing Test Product 1, Test Product 2 and Test Product 3 in people with Muscle Strength, run by Roquette Canada, LTD. at 1 site in Canada.
Trial summary
The objective of this randomized, triple-blind, comparator controlled, parallel clinical trial is to investigate the functional equivalence of three test products compared to whey protein on muscular performance in a healthy, sedentary adult population. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Strength
- What is being tested?
- Test Product 1, Test Product 2 and Test Product 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2021to 18 Apr 2022
- Phase
- Phase 2
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males \& females between 30 and <60 years of age, inclusive
- Waist circumference < 102 cm (40 inches) in men and < 88 cm (35 inches) in women
- Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
- Or,
- Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
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- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Participant having a sedentary lifestyle defined as not engaging in greater than 60 minutes of regular and structured moderate to vigorous exercise per week
- Self-reported stable body weight for the past 3 months defined as not having gained or lost more than 5 kg of body weight throughout the 3 months prior to baseline
- Agrees to follow and is able to complete the exercise guidelines for the duration of the study
- Motivated to comply with exercise guidelines as assessed by the Self-Motivation Questionnaire at screening
- Agrees to avoid vigorous exercise outside of regular routine for 48 hours prior to and after exercise challenge
- Agrees to maintain their daily caloric intake
- Willingness to complete questionnaires, records and diaries associated with the study and to complete all study assessments
- Willing to refrain from taking NSAID for 24 hours prior to and 72 post study appointments
- Provided voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history, laboratory results and electrocardiogram (ECG), as assessed by Qualified Investigator (QI)
Who cannot join
- Women who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients. Adheres to a vegan diet
- Engaged in regular and structured resistance training (≥2x times per week) as assessed by the QI
- Currently experiencing any medical condition that interferes with the ability to undergo physical strength testing during the study and/or ability to complete exercise guidelines as assessed by the QI
- Metal implants that may affect the DEXA scan results as assessed on case-by-case basis by the QI
- Participants who have followed a specific diet (e.g. ketogenic, paleo, etc.) or have had a change of diet within 30 days of baseline as assessed by the QI
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- Current regular use of a protein supplement unless willing to washout (Section 7.3.2)
- Current use of over-the-counter medications, dietary supplements, foods/drinks for muscle building or function unless willing to washout (Section 7.3.2)
- Current use of prescribed medications for muscle building or function (see Section 7.3.1)
- Current use of prescribed steroidal anti-inflammatory medications (see Section 7.3.1), or anti-inflammatory over-the-counter medications or supplements (see Section 7.3.2) unless willing to washout
- Significant cardiovascular event or revascularization in the past 6 months. Participants with history of cardiovascular event or revascularization will be assessed case by case by the QI. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis.
- History of kidney stones will be assessed by the QI on a case-by-case basis
- Self-reported confirmation of a HIV-, Hepatitis B- or C-positive diagnosis, autoimmune disease or those that are immune compromised
- Self-reported confirmation of blood/bleeding disorders
- Alcohol intake >2 standard drinks per day
- Blood donation 30 days prior to screening, during the study, or a planned donation within 30 days of the last study appointment as assessed by the QI
- Participation in other pharmaceutical, weight loss/diet, exercise intervention or clinical research studies 30 days prior to enrollment as assessed by the QI
- Individuals who are unable to give informed consent
- Any other condition, chronic disease or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Triple-blind, Comparator Controlled, Parallel Clinical Trial to Study the Efficacy and Safety of Three Test Products and Comparator on Muscular Performance in a Healthy, Sedentary Adult Population After the Initiation of a Resistance Training Program
The objective of this randomized, triple-blind, comparator controlled, parallel clinical trial is to investigate the functional equivalence of three test products compared to whey protein on muscular performance in a healthy, sedentary adult population.
Read the detailed description
Whey, a by-product of cheese manufacturing, is commonly used as an ingredient in meat products, dairy products, baked goods, snacks, beverages, and infant formula. Its widespread use is due to its advantageous effects on health, economics, and high nutritional value by containing lactose, minerals, vitamins, and soluble proteins. Due to allergies, dietary restrictions and/or personal dietary choices there is a need for an alternative protein source(s), and plant-based protein options are in demand for these reasons. Roquette produces the NUTRALYS® Pea Protein family of ingredients, supplying the widest range of pea protein ingredients to the food industry suitable for use in a plethora of plant-based foods. Few studies have examined the equivalence between pea protein and whey on muscle performance in sedentary adults. The objective of this randomized, triple-blind, comparator controlled, parallel clinical trial is to investigate the functional equivalence of three test products compared to whey protein on muscular performance in a healthy, sedentary adult population.
- Conditions
- Muscle Strength
- Being tested
- Test Product 1, Test Product 2, Test Product 3, Comparator
- Keywords
- pea protein, oat protein, whey protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Product 1Other
Pea Protein powder
Test Product 2Other
Pea \& Oat Protein Powder
Test Product 3Other
Oat Protein Powder
ComparatorOther
Whey Protein Isolate
| Study group | Role | What they receive |
|---|---|---|
| Pea Protein Powder | Experimental | Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks. Receives: Other: Test Product 1 |
| Pea & Oat Protein Powder | Experimental | Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks. Receives: Other: Test Product 2 |
| Oat Protein Powder | Experimental | Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks. Receives: Other: Test Product 3 |
| Whey Protein Isolate | Active comparator | Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks. Receives: Other: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in composite whole-body muscle strength
The difference in composite whole-body muscle strength, as assessed by the sum of handgrip, elbow flexion and extension and knee flexion and extension strength from baseline to day 84 between IPs 1, 2, 3 and comparator.
Measured: From baseline to day 84
Secondary outcomes (14)
The difference in change in handgrip strength
The difference in change in muscle strength as assessed by handgrip strength from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator
Measured: From baseline to days 28, 56 and 84
The difference in change in isometric leg strength
The difference in change in muscle strength as assessed by isometric leg strength from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator
Measured: From baseline to days 28, 56 and 84
The difference in change in upper body strength
The difference in change in muscle strength as assessed by upper body strength from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator
Measured: From baseline to days 28, 56 and 84
The difference in change in weight
The difference in change in body composition: weight from baseline to day 84 between IPs 1, 2, 3 and comparator
Measured: From baseline to day 84
The difference in change in waist circumference
The difference in change in body composition: waist circumference as assessed by physical measurements from baseline to day 84 between IPs 1, 2, 3 and comparator
Measured: From baseline to day 84
The difference in change in android/gynoid fat ratio
The difference in change in body composition: android/gynoid fat ratio as assessed by DXA from baseline to day 84 between IPs 1, 2, 3 and comparator
Measured: From baseline to day 84
The difference in change in fat mass (% or g)
The difference in change in body composition: fat mass (% or g) as assessed by DXA from baseline to day 84 between IPs 1, 2, 3 and comparator
Measured: From baseline to day 84
The difference in change in muscle mass (% or g)
The difference in change in body composition: muscle mass (% or g) as assessed by DXA from baseline to day 84 between IPs 1, 2, 3 and comparator
Measured: From baseline to day 84
The difference in change in endurance performance
The difference in change in endurance performance as assessed by Treadmill Walk Test from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator
Measured: From baseline to days 28, 56 and 84
The difference in change in quality of life
The difference in change in quality of life as assessed by RAND SF-36 Quality of Life Questionnaire from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator
Measured: From baseline to days 28, 56 and 84
The difference in change in blood CRP concentrations
The difference in change in blood CRP concentrations from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator
Measured: From baseline to days 28, 56 and 84
The difference in change in immune function
The difference in change in immune function as assessed by white blood cell (WBC), lymphocyte and neutrophil counts from screening to day 84 between IPs 1, 2, 3 and comparator
Measured: From screening to day 84
The difference in change in product tolerability
The difference in change in product tolerability as assessed by Modified Gastrointestinal Symptoms Rating Scale (GSRS) from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator
Measured: From baseline to days 28, 56 and 84
The difference in product perception
The difference in product perception as assessed by the Product Perception Questionnaire at day 84 between IPs 1, 2, 3 and comparator
Measured: At day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Apr 2021
- Primary completion18 Apr 2022
- Study completion18 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle StrengthStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, triple-blind, comparator controlled, parallel clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roquette Canada, LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814225
- Sponsor's protocol ID
- 21PMHR
- Status last verified
- Apr 2022
- First submitted
- 22 Mar 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-blind, Comparator Controlled, Parallel Clinical Trial to Study the Efficacy and Safety of Three Test Products and Comparator on Muscular Performance in a Healthy, Sedentary Adult Population After the Initiation of a Resistance Training Program
- ClinicalTrials.gov ID
- NCT04814225
- Acronym / sponsor ID
- 21PMHR
- Conditions
- Muscle Strength
- Keywords
- pea protein, oat protein, whey protein
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Roquette Canada, LTD.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 18 Apr 2022 (actual)
- First posted
- 24 Mar 2021 (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.
The objective of this randomized, triple-blind, comparator controlled, parallel clinical trial is to investigate the functional equivalence of three test products compared to whey protein on muscular performance in a healthy, sedentary adult population.
Detailed description
Whey, a by-product of cheese manufacturing, is commonly used as an ingredient in meat products, dairy products, baked goods, snacks, beverages, and infant formula. Its widespread use is due to its advantageous effects on health, economics, and high nutritional value by containing lactose, minerals, vitamins, and soluble proteins. Due to allergies, dietary restrictions and/or personal dietary choices there is a need for an alternative protein source(s), and plant-based protein options are in demand for these reasons. Roquette produces the NUTRALYS® Pea Protein family of ingredients, supplying the widest range of pea protein ingredients to the food industry suitable for use in a plethora of plant-based foods. Few studies have examined the equivalence between pea protein and whey on muscle performance in sedentary adults. The objective of this randomized, triple-blind, comparator controlled, parallel clinical trial is to investigate the functional equivalence of three test products compared to whey protein on muscular performance in a healthy, sedentary adult population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A randomized, triple-blind, comparator controlled, parallel clinical trial
| Arm | Type | Receives |
|---|---|---|
| Pea Protein Powder | Experimental | Other: Test Product 1Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks. |
| Pea & Oat Protein Powder | Experimental | Other: Test Product 2Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks. |
| Oat Protein Powder | Experimental | Other: Test Product 3Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks. |
| Whey Protein Isolate | Active comparator | Other: ComparatorParticipants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Males \& females between 30 and <60 years of age, inclusive
- Waist circumference < 102 cm (40 inches) in men and < 88 cm (35 inches) in women
- Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
- Or,
- Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
Key exclusion criteria (19 listed)
- Women who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients. Adheres to a vegan diet
- Engaged in regular and structured resistance training (≥2x times per week) as assessed by the QI
- Currently experiencing any medical condition that interferes with the ability to undergo physical strength testing during the study and/or ability to complete exercise guidelines as assessed by the QI
- Metal implants that may affect the DEXA scan results as assessed on case-by-case basis by the QI
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 |
|---|---|---|
| Test Product 1Pea Protein powder | Other | Pea Protein Powder |
| Test Product 2Pea \& Oat Protein Powder | Other | Pea & Oat Protein Powder |
| Test Product 3Oat Protein Powder | Other | Oat Protein Powder |
| ComparatorWhey Protein Isolate | Other | Whey Protein Isolate |
Primary outcome
The difference in composite whole-body muscle strength
Time frame: From baseline to day 84
The difference in composite whole-body muscle strength, as assessed by the sum of handgrip, elbow flexion and extension and knee flexion and extension strength from baseline to day 84 between IPs 1, 2, 3 and comparator.
14 secondary outcomes
The difference in change in handgrip strength
Time frame: From baseline to days 28, 56 and 84
The difference in change in isometric leg strength
Time frame: From baseline to days 28, 56 and 84
The difference in change in upper body strength
Time frame: From baseline to days 28, 56 and 84
The difference in change in weight
Time frame: From baseline to day 84
The difference in change in waist circumference
Time frame: From baseline to day 84
The difference in change in android/gynoid fat ratio
Time frame: From baseline to day 84
The difference in change in fat mass (% or g)
Time frame: From baseline to day 84
The difference in change in muscle mass (% or g)
Time frame: From baseline to day 84
The difference in change in endurance performance
Time frame: From baseline to days 28, 56 and 84
The difference in change in quality of life
Time frame: From baseline to days 28, 56 and 84
The difference in change in blood CRP concentrations
Time frame: From baseline to days 28, 56 and 84
The difference in change in immune function
Time frame: From screening to day 84
The difference in change in product tolerability
Time frame: From baseline to days 28, 56 and 84
The difference in product perception
Time frame: At day 84
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 27 Apr 2022.
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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.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Test Product 1, Test Product 2 and Test Product 3 in people with Muscle Strength, run by Roquette Canada, LTD. 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 20 inclusion and 19 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 27 Apr 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The difference in composite whole-body muscle strength (time frame: From baseline to day 84). 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 27 Apr 2022.