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
Sponsor study identifier
interventional
100
1 country
1
Study Start
April 1, 2021
Actual (reported)Primary Completion
April 18, 2022
Actual (reported)Study Completion
April 18, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 18, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 22, 2021
Actual (reported)March 24, 2021
Actual (reported)April 1, 2021
Actual (reported)April 18, 2022
Actual (reported)April 18, 2022
Actual (reported)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
The difference in change in handgrip strength
From baseline to days 28, 56 and 84
The difference in change in isometric leg strength
From baseline to days 28, 56 and 84
The difference in change in upper body strength
From baseline to days 28, 56 and 84
The difference in change in weight
From baseline to day 84
The difference in change in waist circumference
From baseline to day 84
The difference in change in immune function: cytokine response in (TNF)-α
From baseline to days 28, 56 and 84
The difference in change in immune function: cytokine response in IL-6
From baseline to days 28, 56 and 84
The difference in change in immune function: cytokine response in IL-10
From baseline to days 28, 56 and 84
Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks.
Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks.
Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks.
Pea Protein powder
Pea \& Oat Protein Powder
KGK Science
London, Ontario, N6A 5R8, Canada
David Crowley, MD
KGK Science Inc.
100 participants (actual enrollment reported by the registry).
First Submitted
March 22, 2021
First Posted
March 24, 2021
Study Start
April 1, 2021
Actual (reported)Participants will be instructed to mix the IP with 250 mL room temperature water once/day for 12 weeks.
Oat Protein Powder
Whey Protein Isolate
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
April 18, 2022
Actual (reported)Study Completion
April 18, 2022
Actual (reported)Last Updated
April 27, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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