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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
100
Pea Protein powder
Pea \& Oat Protein Powder
Oat Protein Powder
KGK Science
London, Ontario, Canada
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
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
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
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
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
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
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Whey Protein Isolate
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
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
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
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
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
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
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
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
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