- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04437758
Effects of Hydrolyzed Collagen and Vitamin C on Explosive Performance
June 16, 2020 updated by: PepsiCo Global R&D
Determine whether supplementation with a combined dose of 20 g of hydrolyzed collagen and 50 mg vitamin C, along with a power training exercise program, increases rate of force development (RFD) and performance in athletes
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Davis, California, United States, 95616
- UC Davis Functional Molecular Biology Laboratory and Human Performance Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male athletes between 18-30 years of age
- Currently participating in sport
- <3 musculoskeletal injuries in the past year
- No health or dietary restriction that would be affected by the supplementation protocol
Exclusion Criteria:
- History of more than 3 musculoskeletal injuries within the past 12 months
- Health, dietary restriction or diet that would be affected by the supplementation protocol
- Willing to eat similar dietary pattern the day before baseline testing and each exercise testing/intervention day
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hydrolyzed collagen and Vitamin C powder mix
20 g hydrolyzed collagen + 50 mg vitamin C (ascorbic acid) pre-packed powder diluted in 250 ml (8 oz) of water
|
20 g collagen + 50 mg vitamin C daily, 60 min prior to exercise
Explosive/power-based exercise training program 3 times/week at home consisting of drop jumps, box jumps, weighted jump squats loaded in a progressive manner weekly for 3 weeks.
At baseline and at the end of each of the 3 weeks, measures of explosive performance are assessed in the lab (maximal isometric squat, counter-movement jump and squat jump)
|
Placebo Comparator: Maltodextrin powder
20 g maltodextrin pre-packed powder diluted in 250 ml (8 oz) of water
|
Explosive/power-based exercise training program 3 times/week at home consisting of drop jumps, box jumps, weighted jump squats loaded in a progressive manner weekly for 3 weeks.
At baseline and at the end of each of the 3 weeks, measures of explosive performance are assessed in the lab (maximal isometric squat, counter-movement jump and squat jump)
20 g maltodextrin placebo daily, 60 min prior to exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal rate of force development (RFD) of isometric squat (MIS)
Time Frame: % change from baseline to week 1, week 2 and week 3
|
Force (N) over time (msec) for the maximum slope of the first 20% of the movement
|
% change from baseline to week 1, week 2 and week 3
|
Counter-movement jump (CMJ) rate of force development (RFD)
Time Frame: % change from baseline to week 1, week 2 and week 3
|
CMJ jump performance N/s/kg
|
% change from baseline to week 1, week 2 and week 3
|
Squat jump height rate of force development (RFD)
Time Frame: % change from baseline to week 1, week 2 and week 3
|
Squat jump height performance RFD/kg
|
% change from baseline to week 1, week 2 and week 3
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum peak force of maximal isometric squat (MIS)
Time Frame: % change from baseline to week 1, week 2 and week 3
|
Peak force (N)
|
% change from baseline to week 1, week 2 and week 3
|
Counter-movement jump (CMJ) net eccentric impulse
Time Frame: % change from baseline to week 1, week 2 and week 3
|
Jump performance max N/s/kg (Note: Eccentric is the drop down part of the CMJ)
|
% change from baseline to week 1, week 2 and week 3
|
Counter-movement jump (CMJ) net concentric impulse
Time Frame: % change from baseline to week 1, week 2 and week 3
|
Jump performance max N/s/kg (Note: Concentric is the movement upwards of the CMJ)
|
% change from baseline to week 1, week 2 and week 3
|
Leg stiffness assessment
Time Frame: % change from baseline to week 1, week 2 and week 3
|
Tendon stiffness mean per kg (N/m/kg)
|
% change from baseline to week 1, week 2 and week 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Keith Baar, PhD, University of California, Davis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 22, 2019
Primary Completion (Actual)
February 5, 2020
Study Completion (Actual)
February 5, 2020
Study Registration Dates
First Submitted
June 12, 2020
First Submitted That Met QC Criteria
June 16, 2020
First Posted (Actual)
June 18, 2020
Study Record Updates
Last Update Posted (Actual)
June 18, 2020
Last Update Submitted That Met QC Criteria
June 16, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEP-1704
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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