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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pea Protein Powder | Experimental | Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks. |
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| Pea & Oat Protein Powder | Experimental | Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks. |
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| Oat Protein Powder | Experimental | Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks. |
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| Whey Protein Isolate | Active Comparator | Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Product 1 | Other | Pea Protein powder |
| |
| Test Product 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline to days 28, 56 and 84 |
| The difference in change in isometric leg strength |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline to days 28, 56 and 84 |
| The difference in change in immune function: cytokine response in IL-6 |
Inclusion Criteria:
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:
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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science | London | Ontario | N6A 5R8 | Canada |
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A randomized, triple-blind, comparator controlled, parallel clinical trial
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| Other |
Pea & Oat Protein Powder |
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| Test Product 3 | Other | Oat Protein Powder |
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| Comparator | Other | Whey Protein Isolate |
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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 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | At day 84 |
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 |
| From baseline to days 28, 56 and 84 |
| 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 | From baseline to days 28, 56 and 84 |
| Munich ChronoType Questionnaire | The difference in Munich ChronoType Questionnaire (MCTQ) at baseline between IPs 1, 2, 3 and comparator | At baseline |
| 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 | At baseline, day 28, 56 and 84 |
| Incidence of pre-emergent and post-emergent adverse events | Incidence of pre-emergent and post-emergent adverse events | From baseline to day 84 |
| Blood pressure (BP) | Systolic and Diastolic | At baseline, day 28, 56 and 84 |
| Heart rate (HR) | Heart rate | At baseline, day 28, 56 and 84 |
| Aspartate aminotransferase (AST) | Aspartate aminotransferase (AST) | At baseline and 84 |
| Alanine aminotransferase (ALT) | Alanine aminotransferase (ALT) | At baseline and 84 |
| Alkaline phosphatase (ALP) | Alkaline phosphatase (ALP) | At baseline and 84 |
| Total bilirubin | Total bilirubin | At baseline and 84 |
| Creatinine | Creatinine | At baseline and 84 |
| Electrolytes (Na, K, Cl) | Electrolytes (Na, K, Cl) | At baseline and 84 |
| Glucose | Glucose | At baseline and 84 |
| Estimated glomerular filtration rate (eGFR) | Estimated glomerular filtration rate (eGFR) | At baseline and 84 |
| Hematology (monocytes, eosinophils, basophils) | Hematology (monocytes, eosinophils, basophils) | At baseline and 84 |
| Red blood cell (RBC) count | Red blood cell (RBC) count | At baseline and 84 |
| Hemoglobin | Hemoglobin | At baseline and 84 |
| Hematocrit | Hematocrit | At baseline and 84 |
| Platelet count | Platelet count | At baseline and 84 |
| Mean corpuscular volume (MCV) | RBC indices: mean corpuscular volume (MCV) | At baseline and 84 |
| Mean corpuscular hemoglobin (MCH) | RBC indices: mean corpuscular hemoglobin (MCH) | At baseline and 84 |
| Mean corpuscular hemoglobin concentration (MCHC) | RBC indices: mean corpuscular hemoglobin concentration (MCHC) | At baseline and 84 |
| Red cell distribution width (RDW) | RBC indices: red cell distribution width (RDW) | At baseline and 84 |