Collagen SynthesisNCT04437758
Effects of Hydrolyzed Collagen and Vitamin C on Explosive Performance
A study testing Collagen and Vitamin C powder mix nutritional intervention and Maximum power training exercise in people with Collagen Synthesis and Rate of Force (RFD) Development, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Collagen Synthesis, Rate of Force (RFD) Development
- What is being tested?
- Collagen and Vitamin C powder mix nutritional intervention and Maximum power training exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2019to 5 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Functional Molecular Biology Laboratory and Human Performance Laboratory
Davis, California, 95616
About this study
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
- Being tested
- Collagen and Vitamin C powder mix nutritional intervention, Maltodextrin placebo powder, Maximum power training exercise
- Keywords
- exercise, performance, athletes
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen and Vitamin C powder mix nutritional interventionDietary supplement
20 g collagen + 50 mg vitamin C daily, 60 min prior to exercise
Maltodextrin placebo powderOther
20 g maltodextrin placebo daily, 60 min prior to exercise
Maximum power training exerciseOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Hydrolyzed collagen and Vitamin C powder mix | Experimental | 20 g hydrolyzed collagen + 50 mg vitamin C (ascorbic acid) pre-packed powder diluted in 250 ml (8 oz) of water Receives: Dietary Supplement: Collagen and Vitamin C powder mix nutritional intervention; Other: Maximum power training exercise |
| Maltodextrin powder | Placebo comparator | 20 g maltodextrin pre-packed powder diluted in 250 ml (8 oz) of water Receives: Other: Maltodextrin placebo powder; Other: Maximum power training exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal rate of force development (RFD) of isometric squat (MIS)
Force (N) over time (msec) for the maximum slope of the first 20% of the movement
Measured: % change from baseline to week 1, week 2 and week 3
Counter-movement jump (CMJ) rate of force development (RFD)
CMJ jump performance N/s/kg
Measured: % change from baseline to week 1, week 2 and week 3
Squat jump height rate of force development (RFD)
Squat jump height performance RFD/kg
Measured: % change from baseline to week 1, week 2 and week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start22 Aug 2019
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collagen SynthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Baar, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437758
- Sponsor's protocol ID
- PEP-1704
- Status last verified
- Jun 2020
- First submitted
- 12 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hydrolyzed Collagen and Vitamin C on Explosive Performance
- ClinicalTrials.gov ID
- NCT04437758
- Acronym / sponsor ID
- PEP-1704
- Keywords
- exercise, performance, athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrolyzed collagen and Vitamin C powder mix | Experimental | Dietary Supplement: Collagen and Vitamin C powder mix nutritional intervention, Other: Maximum power training exercise20 g hydrolyzed collagen + 50 mg vitamin C (ascorbic acid) pre-packed powder diluted in 250 ml (8 oz) of water |
| Maltodextrin powder | Placebo comparator | Other: Maltodextrin placebo powder, Other: Maximum power training exercise20 g maltodextrin pre-packed powder diluted in 250 ml (8 oz) of water |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagen and Vitamin C powder mix nutritional intervention20 g collagen + 50 mg vitamin C daily, 60 min prior to exercise | Dietary supplement | Hydrolyzed collagen and Vitamin C powder mix |
| Maltodextrin placebo powder20 g maltodextrin placebo daily, 60 min prior to exercise | Other | Maltodextrin powder |
| Maximum power training exerciseExplosive/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) | Other | Hydrolyzed collagen and Vitamin C powder mix, Maltodextrin powder |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Baar, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen and Vitamin C powder mix nutritional intervention and Maximum power training exercise in people with Collagen Synthesis and Rate of Force (RFD) Development, run by PepsiCo Global R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal rate of force development (RFD) of isometric squat (MIS) (time frame: % change from baseline to week 1, week 2 and week 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.