Effect of Food SupplementNCT05427279
Effects of Vitamin C Enriched Hydrolyzed Collagen, PrimaColl™, Whey Protein, or Placebo on Collagen Synthesis
A study testing Hydrolized Collagen, PrimaColl and Whey protein in people with Effect of Food Supplement, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of repeated dosing vitamin C enriched hydrolyzed collagen (HC) over a 24hr period, compared to PrimaColl™ (PC), whey protein (WP) and placebo (PL), with prescribed exercise on collagen synthesis. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Food Supplement
- What is being tested?
- Hydrolized Collagen, PrimaColl and Whey protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2022to 30 Sep 2024
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy active male or female
- normal weight (BMI between 18 and 25 kg/m2)
Who cannot join
- taking any medication that may interfere with the study
- have a history of more than 3 musculoskeletal injuries within the past 12 months
- have any health or dietary restriction that would be affected by the supplementation protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effects of 24-hours of Repeated Doses of Vitamin C Enriched Hydrolyzed Collagen, PrimaColl™, Whey Protein, or Placebo on Collagen Synthesis
The purpose of this study is to determine the effects of repeated dosing vitamin C enriched hydrolyzed collagen (HC) over a 24hr period, compared to PrimaColl™ (PC), whey protein (WP) and placebo (PL), with prescribed exercise on collagen synthesis.
To achieve this, participants will consume a supplemental dose of HC (20g with 50mg vitamin C), PC (20g with 50mg vitamin C), whey protein (20g whey isolate with 50mg vitamin C) or a placebo (20g maltodextrin with 50mg vitamin C) 1hr prior to an exercise bout (6 minutes of jump rope), this will be repeated three times over a 24h period.
The amount of collagen protein synthesized will be indirectly measured by measuring pro-collagen type I N-terminal propeptide (PINP) in the serum before and 4hrs after the last exercise bout.
Read the detailed description
The purpose of this study is to determine the effects of repeated dosing of vitamin C enriched hydrolyzed collagen (HC) over a 24hr period, compared to PrimaColl™ (PC), whey protein (WP) and placebo (PL), with prescribed exercise on collagen synthesis.
To achieve this, participants will consume a supplemental dose of HC (20g with 50mg vitamin C), PC (20g with 50mg vitamin C), whey protein (20g whey isolate with 50mg vitamin C) or a placebo (20g maltodextrin with 50mg vitamin C) 1hr prior to exercise bouts (6 minutes of jump rope). The amount of collagen protein synthesized will be indirectly measured by measuring procollagen type I N-terminal propeptide (PINP) in the serum before and 4hrs after the last exercise bout.
It is expected that this project will determine whether greater increases in collagen synthesis are observed with repeated doses of HC and exercise, compared with a single dose and exercise bout (from previous research). This study will also determine whether collagen synthesis is similarly stimulated with PrimaColl, or whey protein. Results from this study will help to better prescribe the use of dietary collagen and exercise training to improve collagen synthesis in healthy young people. Improved collagen synthesis has the potential to decrease ligament, tendon, and bone injuries in the general and athletic populations.
Male and female participants between the ages of 18-30 years of age will be enrolled in the study. A randomized double-blind crossover design with neither the subjects nor the investigators knowing who is on which treatment (HC, PC, WP or PL).
- Baseline blood draw
The subjects will arrive in the laboratory following an overnight fast. The antecubital vein will be cannulated, and an initial 5 mL baseline blood sample will be collected.
II. Supplementation
After baseline blood draw subjects will be provided with a supplement as shown in the table below. Subjects will be asked to consume the supplement that will be pre-mixed with 250 ml of water 60 min before the jump rope exercise. This will be repeated 3 times, separated by 12 hours over a 24h period.
III. Exercise
Sixty minutes after the ingestion of the supplement, each participant will complete 6 minutes of jump rope. This will be repeated on 3 occasions over a 24hr period. Subjects will be asked to abstain from vigorous exercise during the 24hr period, aside from the prescribed jump rope exercise.
Subjects will be asked to ingest supplement and jump rope in lab for time point 1. Subjects will be given the option to ingest supplement and jump rope outside lab if more conducive to their scheduling restrictions at time points 2 and 3 blood draws are not required at these timepoints. Subjects will be asked to return to the lab 4 hours after last jumping session for blood sampling.
Blood draws for PNIP analysis
Blood samples (5 mL) at different time points:
- Baseline 2 vials will be drawn (1 for PINP and the other for bioassays)
- 1h after the first supplementation 1 vial will be drawn (bioassay)
- 4hrs post-exercise session number 3 the last vial will be drawn (PINP) Blood will be collected in 5 mL serum separating tubes and allowed to clot for 1hr before centrifugation at 1000 x g for 10 minutes and the serum will be frozen and kept at -30°C until processed. PINP levels will be determined by electrochemiluminescence (ECL; Roche Diagnostics, Indianapolis, IN) according to the manufacturer's instructions. The total number of blood draws will be 12 (3 per intervention with 4 interventions). Treatments will be randomized to avoid an order effect and a washout period of about 72h between trials will be used to minimize the effect of the previous treatment
- Conditions
- Effect of Food Supplement
- Being tested
- Placebo, Hydrolized Collagen, PrimaColl, Whey protein
- Keywords
- Collagen synthesis, Exercise, Supplementation, Engineered ligaments
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Also called maltodextrin
The participant will consume a supplemental dose of a placebo (20g maltodextrin with 50mg vitamin C)
Hydrolized CollagenDietary supplement
The participant will consume a supplemental dose of Hydrolized collagen (20g with 50mg vitamin C)
PrimaCollDietary supplement
The participant will consume a supplemental dose of PrimaColl, a vegan collagen supplementation (20g with 50mg vitamin C)
Whey proteinDietary supplement
The participant will consume a supplemental dose of whey protein (20g whey isolate with 50mg vitamin C)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | This arm will be given a placebo (20g maltodextrin with 50mg vitamin C) Receives: Dietary Supplement: Placebo |
| Hydrolized Collagen | Experimental | This arm will be given Hydrolized Collagen (20g with 50mg vitamin C) Receives: Dietary Supplement: Hydrolized Collagen |
| PrimaColl | Experimental | This arm will be given PrimaColl, a vegan collagen supplementation (20g with 50mg vitamin C) Receives: Dietary Supplement: PrimaColl |
| Whey Protein | Experimental | This arm will be given whey protein (20g with 50mg vitamin C) Receives: Dietary Supplement: Whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collagen protein synthesis
Collagen protein synthesis will be indirectly measured by measuring pro-collagen type I N-terminal propeptide (PINP) in the serum before and 4 hours after the last exercise bout (at 28 hours of the protocol)
Measured: Baseline (0 hour) to 4 hours after last exercise bout (at 28 hour of the protocol)
Secondary outcomes (2)
Ligament collagen content
Serum from participants will be used to treat engineered ligaments in order to assess the effect of the different supplementation on the ligament collagen content using a hydroxyproline assay kit.
Measured: Baseline (0 hour) to directly after consumption of supplementation (1 hour)
Strength of engineered ligaments
Serum from participants will be used to treat engineered ligaments in order to measure the effect of the different supplementation on the strength of the ligaments, the strength will be measured using the Instron bio puls 68SC-1 tension and compression machine.
Measured: Baseline (0 hour) to directly after consumption of supplementation (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start5 Oct 2022
- Primary completion30 Jun 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Food SupplementStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will consume a supplemental dose of hydrolyzed collagen (20g with 50mg vitamin C), PrimaColl (20g with 50mg vitamin C), whey protein (20g whey isolate with 50mg vitamin C) or a placebo (20g maltodextrin with 50mg vitamin C) 1hr prior to exercise bouts (6 minutes of jump rope). The type of consumed supplementation will be randomized where neither the participant nor investigator will know which supplement is being consumed. Each participant will repeat the protocol four times.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Geltor
- Responsible party
- Sponsor
- Investigators
- Keith Baar, PhD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427279
- Sponsor's protocol ID
- 220518
- Status last verified
- May 2026
- First submitted
- 9 Jun 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of 24-hours of Repeated Doses of Vitamin C Enriched Hydrolyzed Collagen, PrimaColl™, Whey Protein, or Placebo on Collagen Synthesis
- ClinicalTrials.gov ID
- NCT05427279
- Acronym / sponsor ID
- 220518
- Conditions
- Effect of Food Supplement
- Keywords
- Collagen synthesis, Exercise, Supplementation, Engineered ligaments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Geltor
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 22 Jun 2022 (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.
The purpose of this study is to determine the effects of repeated dosing vitamin C enriched hydrolyzed collagen (HC) over a 24hr period, compared to PrimaColl™ (PC), whey protein (WP) and placebo (PL), with prescribed exercise on collagen synthesis.
To achieve this, participants will consume a supplemental dose of HC (20g with 50mg vitamin C), PC (20g with 50mg vitamin C), whey protein (20g whey isolate with 50mg vitamin C) or a placebo (20g maltodextrin with 50mg vitamin C) 1hr prior to an exercise bout (6 minutes of jump rope), this will be repeated three times over a 24h period.
The amount of collagen protein synthesized will be indirectly measured by measuring pro-collagen type I N-terminal propeptide (PINP) in the serum before and 4hrs after the last exercise bout.
Detailed description
The purpose of this study is to determine the effects of repeated dosing of vitamin C enriched hydrolyzed collagen (HC) over a 24hr period, compared to PrimaColl™ (PC), whey protein (WP) and placebo (PL), with prescribed exercise on collagen synthesis.
To achieve this, participants will consume a supplemental dose of HC (20g with 50mg vitamin C), PC (20g with 50mg vitamin C), whey protein (20g whey isolate with 50mg vitamin C) or a placebo (20g maltodextrin with 50mg vitamin C) 1hr prior to exercise bouts (6 minutes of jump rope). The amount of collagen protein synthesized will be indirectly measured by measuring procollagen type I N-terminal propeptide (PINP) in the serum before and 4hrs after the last exercise bout.
It is expected that this project will determine whether greater increases in collagen synthesis are observed with repeated doses of HC and exercise, compared with a single dose and exercise bout (from previous research). This study will also determine whether collagen synthesis is similarly stimulated with PrimaColl, or whey protein. Results from this study will help to better prescribe the use of dietary collagen and exercise training to improve collagen synthesis in healthy young people. Improved collagen synthesis has the potential to decrease ligament, tendon, and bone injuries in the general and athletic populations.
Male and female participants between the ages of 18-30 years of age will be enrolled in the study. A randomized double-blind crossover design with neither the subjects nor the investigators knowing who is on which treatment (HC, PC, WP or PL).
- Baseline blood draw
The subjects will arrive in the laboratory following an overnight fast. The antecubital vein will be cannulated, and an initial 5 mL baseline blood sample will be collected.
II. Supplementation
After baseline blood draw subjects will be provided with a supplement as shown in the table below. Subjects will be asked to consume the supplement that will be pre-mixed with 250 ml of water 60 min before the jump rope exercise. This will be repeated 3 times, separated by 12 hours over a 24h period.
III. Exercise
Sixty minutes after the ingestion of the supplement, each participant will complete 6 minutes of jump rope. This will be repeated on 3 occasions over a 24hr period. Subjects will be asked to abstain from vigorous exercise during the 24hr period, aside from the prescribed jump rope exercise.
Subjects will be asked to ingest supplement and jump rope in lab for time point 1. Subjects will be given the option to ingest supplement and jump rope outside lab if more conducive to their scheduling restrictions at time points 2 and 3 blood draws are not required at these timepoints. Subjects will be asked to return to the lab 4 hours after last jumping session for blood sampling.
Blood draws for PNIP analysis
Blood samples (5 mL) at different time points:
- Baseline 2 vials will be drawn (1 for PINP and the other for bioassays)
- 1h after the first supplementation 1 vial will be drawn (bioassay)
- 4hrs post-exercise session number 3 the last vial will be drawn (PINP) Blood will be collected in 5 mL serum separating tubes and allowed to clot for 1hr before centrifugation at 1000 x g for 10 minutes and the serum will be frozen and kept at -30°C until processed. PINP levels will be determined by electrochemiluminescence (ECL; Roche Diagnostics, Indianapolis, IN) according to the manufacturer's instructions. The total number of blood draws will be 12 (3 per intervention with 4 interventions). Treatments will be randomized to avoid an order effect and a washout period of about 72h between trials will be used to minimize the effect of the previous treatment
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will consume a supplemental dose of hydrolyzed collagen (20g with 50mg vitamin C), PrimaColl (20g with 50mg vitamin C), whey protein (20g whey isolate with 50mg vitamin C) or a placebo (20g maltodextrin with 50mg vitamin C) 1hr prior to exercise bouts (6 minutes of jump rope). The type of consumed supplementation will be randomized where neither the participant nor investigator will know which supplement is being consumed. Each participant will repeat the protocol four times.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis arm will be given a placebo (20g maltodextrin with 50mg vitamin C) |
| Hydrolized Collagen | Experimental | Dietary Supplement: Hydrolized CollagenThis arm will be given Hydrolized Collagen (20g with 50mg vitamin C) |
| PrimaColl | Experimental | Dietary Supplement: PrimaCollThis arm will be given PrimaColl, a vegan collagen supplementation (20g with 50mg vitamin C) |
| Whey Protein | Experimental | Dietary Supplement: Whey proteinThis arm will be given whey protein (20g with 50mg vitamin C) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy active male or female
- normal weight (BMI between 18 and 25 kg/m2)
Key exclusion criteria (3 listed)
- taking any medication that may interfere with the study
- have a history of more than 3 musculoskeletal injuries within the past 12 months
- have any health or dietary restriction that would be affected by the supplementation protocol
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 |
|---|---|---|
| PlaceboAlso: maltodextrinThe participant will consume a supplemental dose of a placebo (20g maltodextrin with 50mg vitamin C) | Dietary supplement | Placebo |
| Hydrolized CollagenThe participant will consume a supplemental dose of Hydrolized collagen (20g with 50mg vitamin C) | Dietary supplement | Hydrolized Collagen |
| PrimaCollThe participant will consume a supplemental dose of PrimaColl, a vegan collagen supplementation (20g with 50mg vitamin C) | Dietary supplement | PrimaColl |
| Whey proteinThe participant will consume a supplemental dose of whey protein (20g whey isolate with 50mg vitamin C) | Dietary supplement | Whey Protein |
Primary outcome
Collagen protein synthesis
Time frame: Baseline (0 hour) to 4 hours after last exercise bout (at 28 hour of the protocol)
Collagen protein synthesis will be indirectly measured by measuring pro-collagen type I N-terminal propeptide (PINP) in the serum before and 4 hours after the last exercise bout (at 28 hours of the protocol)
2 secondary outcomes
Ligament collagen content
Time frame: Baseline (0 hour) to directly after consumption of supplementation (1 hour)
Strength of engineered ligaments
Time frame: Baseline (0 hour) to directly after consumption of supplementation (1 hour)
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 8 May 2026.
Related trials for Effect of Food Supplement
RecruitingPhase 2/3
Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
Alcohol Use Disorder, Alcohol Withdrawal
Recruiting
Aquatic Power Training Dosing Strategies and Creatine Supplementation in Older Adults
Aging, Supplementation
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Recruiting
The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
Poor Sleep Quality, Leg Cramps, Nocturnal
Recruiting
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
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
UC 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 Hydrolized Collagen, PrimaColl and Whey protein in people with Effect of Food Supplement, run by University of California, Davis 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 2 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 8 May 2026. 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?
Collagen protein synthesis (time frame: Baseline (0 hour) to 4 hours after last exercise bout (at 28 hour of the protocol)). 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 8 May 2026.