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CompletedNCT04814225Updated Apr 27, 2022

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 interventional study of Test Product 1 and Test Product 2 in Muscle Strength, sponsored by Roquette Canada, LTD.. Completed at 1 site in Canada. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-27.

Sponsored by Roquette Canada, LTD. · Phase 2, Interventional, and Other

Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Muscle Strength

Keywords

  • pea protein
  • oat protein
  • whey protein
03

In context

Lead sponsor

This is the only study on the registry with Roquette Canada, LTD. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Males \& females between 30 and \<60 years of age, inclusive
  2. Waist circumference \< 102 cm (40 inches) in men and \< 88 cm (35 inches) in women

  3. 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)
    • 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
  4. Participant having a sedentary lifestyle defined as not engaging in greater than 60 minutes of regular and structured moderate to vigorous exercise per week
  5. 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
  6. Agrees to follow and is able to complete the exercise guidelines for the duration of the study
  7. Motivated to comply with exercise guidelines as assessed by the Self-Motivation Questionnaire at screening
  8. Agrees to avoid vigorous exercise outside of regular routine for 48 hours prior to and after exercise challenge
  9. Agrees to maintain their daily caloric intake
  10. Willingness to complete questionnaires, records and diaries associated with the study and to complete all study assessments
  11. Willing to refrain from taking NSAID for 24 hours prior to and 72 post study appointments
  12. Provided voluntary, written, informed consent to participate in the study
  13. Healthy as determined by medical history, laboratory results and electrocardiogram (ECG), as assessed by Qualified Investigator (QI)

Exclusion criteria

Exclusion Criteria:

  1. Women who are pregnant, breast feeding, or planning to become pregnant during the study
  2. Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients. Adheres to a vegan diet
  3. Engaged in regular and structured resistance training (≥2x times per week) as assessed by the QI
  4. 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
  5. Metal implants that may affect the DEXA scan results as assessed on case-by-case basis by the QI
  6. 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
  7. Current regular use of a protein supplement unless willing to washout (Section 7.3.2)
  8. Current use of over-the-counter medications, dietary supplements, foods/drinks for muscle building or function unless willing to washout (Section 7.3.2)
  9. Current use of prescribed medications for muscle building or function (see Section 7.3.1)
  10. 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
  11. 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.
  12. History of kidney stones will be assessed by the QI on a case-by-case basis
  13. Self-reported confirmation of a HIV-, Hepatitis B- or C-positive diagnosis, autoimmune disease or those that are immune compromised
  14. Self-reported confirmation of blood/bleeding disorders
  15. Alcohol intake >2 standard drinks per day
  16. 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
  17. Participation in other pharmaceutical, weight loss/diet, exercise intervention or clinical research studies 30 days prior to enrollment as assessed by the QI
  18. Individuals who are unable to give informed consent
  19. 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
05

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Pea Protein Powder

    Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks.

    Other: Test Product 1

  • Experimental
    Pea & Oat Protein Powder

    Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks.

    Other: Test Product 2

  • Experimental
    Oat Protein Powder

    Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks.

    Other: Test Product 3

  • Active comparator
    Whey Protein Isolate

    Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks.

    Other: Comparator

Interventions

  • OtherTest Product 1

    Pea Protein powder

  • OtherTest Product 2

    Pea \& Oat Protein Powder

  • OtherTest Product 3

    Oat Protein Powder

  • OtherComparator

    Whey Protein Isolate

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From baseline to day 84

Secondary outcomes

  1. 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

    Time frame: From baseline to days 28, 56 and 84

  2. 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

    Time frame: From baseline to days 28, 56 and 84

  3. 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

    Time frame: From baseline to days 28, 56 and 84

  4. 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

    Time frame: From baseline to day 84

  5. 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

    Time frame: From baseline to day 84

  6. 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

    Time frame: From baseline to day 84

  7. 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

    Time frame: From baseline to day 84

  8. 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

    Time frame: From baseline to day 84

  9. 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

    Time frame: From baseline to days 28, 56 and 84

  10. 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

    Time frame: From baseline to days 28, 56 and 84

  11. 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

    Time frame: From baseline to days 28, 56 and 84

  12. 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

    Time frame: From screening to day 84

  13. 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

    Time frame: From baseline to days 28, 56 and 84

  14. 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

    Time frame: At day 84

Other outcomes

  1. The difference in change in immune function: cytokine response in (TNF)-α

    The difference in change in immune function as assessed by cytokine response in tumour-necrosis factor (TNF)-α from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator

    Time frame: From baseline to days 28, 56 and 84

  2. The difference in change in immune function: cytokine response in IL-6

    The difference in change in immune function as assessed by cytokine response in interleukin (IL)-6 from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator

    Time frame: From baseline to days 28, 56 and 84

  3. The difference in change in immune function: cytokine response in IL-10

    The difference in change in immune function as assessed by cytokine response in IL-10 from baseline to days 28, 56 and 84 between IPs 1, 2, 3 and comparator

    Time frame: From baseline to days 28, 56 and 84

  4. Munich ChronoType Questionnaire

    The difference in Munich ChronoType Questionnaire (MCTQ) at baseline between IPs 1, 2, 3 and comparator

    Time frame: At baseline

  5. The difference in change in exercise recovery

    The difference in change in exercise recovery as assessed by Delayed Onset Muscle Soreness (DOMS) Questionnaire completed 24-, 48-, and 72-hours following the maximum exercise test performed at baseline, day 28, 56 and 84 between IPs 1, 2, 3 and comparator

    Time frame: At baseline, day 28, 56 and 84

  6. Incidence of pre-emergent and post-emergent adverse events

    Incidence of pre-emergent and post-emergent adverse events

    Time frame: From baseline to day 84

  7. Blood pressure (BP)

    Systolic and Diastolic

    Time frame: At baseline, day 28, 56 and 84

  8. Heart rate (HR)

    Heart rate

    Time frame: At baseline, day 28, 56 and 84

  9. Aspartate aminotransferase (AST)

    Aspartate aminotransferase (AST)

    Time frame: At baseline and 84

  10. Alanine aminotransferase (ALT)

    Alanine aminotransferase (ALT)

    Time frame: At baseline and 84

  11. Alkaline phosphatase (ALP)

    Alkaline phosphatase (ALP)

    Time frame: At baseline and 84

  12. Total bilirubin

    Total bilirubin

    Time frame: At baseline and 84

  13. Creatinine

    Creatinine

    Time frame: At baseline and 84

  14. Electrolytes (Na, K, Cl)

    Electrolytes (Na, K, Cl)

    Time frame: At baseline and 84

  15. Glucose

    Glucose

    Time frame: At baseline and 84

  16. Estimated glomerular filtration rate (eGFR)

    Estimated glomerular filtration rate (eGFR)

    Time frame: At baseline and 84

  17. Hematology (monocytes, eosinophils, basophils)

    Hematology (monocytes, eosinophils, basophils)

    Time frame: At baseline and 84

  18. Red blood cell (RBC) count

    Red blood cell (RBC) count

    Time frame: At baseline and 84

  19. Hemoglobin

    Hemoglobin

    Time frame: At baseline and 84

  20. Hematocrit

    Hematocrit

    Time frame: At baseline and 84

  21. Platelet count

    Platelet count

    Time frame: At baseline and 84

  22. Mean corpuscular volume (MCV)

    RBC indices: mean corpuscular volume (MCV)

    Time frame: At baseline and 84

  23. Mean corpuscular hemoglobin (MCH)

    RBC indices: mean corpuscular hemoglobin (MCH)

    Time frame: At baseline and 84

  24. Mean corpuscular hemoglobin concentration (MCHC)

    RBC indices: mean corpuscular hemoglobin concentration (MCHC)

    Time frame: At baseline and 84

  25. Red cell distribution width (RDW)

    RBC indices: red cell distribution width (RDW)

    Time frame: At baseline and 84

07

Study locations

1 site
  • KGK Science
    London, Ontario N6A 5R8, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04814225
Lead sponsor
Roquette Canada, LTD.
Responsible party
Sponsor
First posted
Mar 24, 2021
Start date
Apr 1, 2021
Primary completion
Apr 18, 2022
Completion
Apr 18, 2022
Last update
Apr 27, 2022

Study contacts

David Crowley, MD
principal investigator · KGK Science Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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