Clinical trial NCT04814225: Investigation of the Efficacy and Safety of Three Test Products and Comparator on Muscular Performance After the Initiation of a Resistance Training Program
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Muscle Strength
Keywords: pea protein
oat protein
whey protein
Lead sponsor: Roquette Canada, LTD.
Sponsor class: INDUSTRY
First posted: 2021-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, triple-blind, comparator controlled, parallel clinical trial
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: The difference in composite whole-body muscle strength
timeFrame: From baseline to day 84
Secondary outcomes:
measure: The difference in change in handgrip strength
timeFrame: From baseline to days 28, 56 and 84
measure: The difference in change in isometric leg strength
timeFrame: From baseline to days 28, 56 and 84
measure: The difference in change in upper body strength
timeFrame: From baseline to days 28, 56 and 84
measure: The difference in change in weight
timeFrame: From baseline to day 84
measure: The difference in change in waist circumference
timeFrame: From baseline to day 84
measure: The difference in change in android/gynoid fat ratio
timeFrame: From baseline to day 84
measure: The difference in change in fat mass (% or g)
timeFrame: From baseline to day 84
measure: The difference in change in muscle mass (% or g)
timeFrame: From baseline to day 84
measure: The difference in change in endurance performance
timeFrame: From baseline to days 28, 56 and 84
measure: The difference in change in quality of life
timeFrame: From baseline to days 28, 56 and 84
measure: The difference in change in blood CRP concentrations
timeFrame: From baseline to days 28, 56 and 84
measure: The difference in change in immune function
timeFrame: From screening to day 84
measure: The difference in change in product tolerability
timeFrame: From baseline to days 28, 56 and 84
measure: The difference in product perception
timeFrame: At day 84
Other outcomes:
measure: The difference in change in immune function: cytokine response in (TNF)-α
timeFrame: From baseline to days 28, 56 and 84
measure: The difference in change in immune function: cytokine response in IL-6
timeFrame: From baseline to days 28, 56 and 84
measure: The difference in change in immune function: cytokine response in IL-10
timeFrame: From baseline to days 28, 56 and 84
measure: Munich ChronoType Questionnaire
timeFrame: At baseline
measure: The difference in change in exercise recovery
timeFrame: At baseline, day 28, 56 and 84
measure: Incidence of pre-emergent and post-emergent adverse events
timeFrame: From baseline to day 84
measure: Blood pressure (BP)
timeFrame: At baseline, day 28, 56 and 84
measure: Heart rate (HR)
timeFrame: At baseline, day 28, 56 and 84
measure: Aspartate aminotransferase (AST)
timeFrame: At baseline and 84
measure: Alanine aminotransferase (ALT)
timeFrame: At baseline and 84
measure: Alkaline phosphatase (ALP)
timeFrame: At baseline and 84
measure: Total bilirubin
timeFrame: At baseline and 84
measure: Creatinine
timeFrame: At baseline and 84
measure: Electrolytes (Na, K, Cl)
timeFrame: At baseline and 84
measure: Glucose
timeFrame: At baseline and 84
measure: Estimated glomerular filtration rate (eGFR)
timeFrame: At baseline and 84
measure: Hematology (monocytes, eosinophils, basophils)
timeFrame: At baseline and 84
measure: Red blood cell (RBC) count
timeFrame: At baseline and 84
measure: Hemoglobin
timeFrame: At baseline and 84
measure: Hematocrit
timeFrame: At baseline and 84
measure: Platelet count
timeFrame: At baseline and 84
measure: Mean corpuscular volume (MCV)
timeFrame: At baseline and 84
measure: Mean corpuscular hemoglobin (MCH)
timeFrame: At baseline and 84
measure: Mean corpuscular hemoglobin concentration (MCHC)
timeFrame: At baseline and 84
measure: Red cell distribution width (RDW)
timeFrame: At baseline and 84
Locations:
city: London
country: Canada
facility: KGK Science
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: David Crowley, MD
role: PRINCIPAL_INVESTIGATOR
References: