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Healthy VolunteersCollagenNCT03293004

Collagen Vitamin C Dose Response Performance

A study testing Hydrolyzed collagen, Vitamin C and Optimized Hydrolyzed Collagen and Vitamin C in people with Healthy Volunteers, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Previous work has shown that gelatin supplementation could increase collagen synthesis in humans. In this study subjects consume placebo, 5 or 15 g of gelatin with a standard amount of vitamin C (48 mg) 1 hour before 6 minutes of jump rope exercise. Read more about this study

Who is it for?
Ages 18 to 25 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Hydrolyzed collagen, Vitamin C and Optimized Hydrolyzed Collagen and Vitamin C
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteUnited States
Study dates
13 Sep 2017to 24 May 2018
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 25 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Collegiate level male athletes between 18 - 25 years of age
  • Currently registered/participating as an intercollegiate athlete
  • < 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.
  • Then initial phases of this study will be performed in males since collagen synthesis varies significantly throughout the menstrual cycle in females. Since collagen in the main outcome measure for this study this natural variation would confound the initial phase of the work. Provided this work proves successful then we will aim to perform similar studies in females.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California Davis

    Davis, California, 95616

Other trials in United States

About this study

Official title: Effects of Hydrolyzed Collagen and Vitamin C on Collagen Synthesis and Explosive Performance

Previous work has shown that gelatin supplementation could increase collagen synthesis in humans. In this study subjects consume placebo, 5 or 15 g of gelatin with a standard amount of vitamin C (48 mg) 1 hour before 6 minutes of jump rope exercise. The feeding and exercise intervention was repeated every 6 hours while the subjects were awake for three days and the amount of the amino terminal procollagen I peptide (PINP) was determined; a marker of collagen synthesis, in the blood. Consistent with the hypothesis that gelatin increases collagen synthesis in humans; the amount of PINP in the 15 g gelatin group was significantly higher than either the placebo or the 5 g groups. These data conclusively demonstrate that gelatin supplementation can increase exercise-induced collagen synthesis in humans. Hydrolyzed collagen has a similar amino acid profile, in particular with high concentrations of glycine, proline, hydroxyproline, and arginine. Thus the current study aims to precisely map out the dose response relationship of hydrolyzed collagen and vitamin C on PINP and to determine the optimal dose to achieve maximal increased in PINP levels.

Read the detailed description

In preliminary work investigating the physiological determinants of maximal performance in throwing events, researchers found that the best predictor of elite performance was the rate of force development (RFD; Force (N) x time (sec)) when performing and isometric squat. Therefore, it is not surprising that in order to maximize performance, athletes train to optimize RFD.

RFD is determined by three factors:

  1. Neural activation of the muscles
  2. Type of motor protein (fast or slow myosin)
  3. Force transfer Interestingly, performance in power movements (that are highly dependent on RFD) like vertical jump is closely related to tendon stiffness and inversely related to muscle size. This indicates that force transfer, in the form of tendon stiffness, plays an important role in performance and can explain a large amount of variance in determining an athlete's ability to rapidly develop force during a dynamic movement.

The stiffness of a tendon is determined by the amount and cross-linking of collagen within the tissue. Acute exercise is known to increase collagen synthesis as well as the expression of the primary enzyme involved in collagen cross-linking, lysyl oxidase. The result is a denser and stiffer tissue after training. Even though the relationship between exercise and collagen synthesis is known, whether this measure of performance can be improved with nutritional interventions has not been determined.

A recent study looking at amino acid levels following consumption of increasing doses of gelatin (derivative of collagen) in human subjects has shown that the key primary and trace amino acids found in collagen increase in human serum after consuming gelatin. Further, the peak of these amino acids occurs 60 minutes after consuming the gelatin supplement. Therefore, consuming a collagen supplement 1 hour before an exercise intervention should maximize delivery of amino acids to bone and other connective tissues.

To determine whether the gelatin supplement could increase collagen synthesis in humans, subjects consumed placebo, 5 or 15 g of gelatin with a standard amount of vitamin C (48 mg) 1 hour before 6 minutes of jump rope exercise. The feeding and exercise intervention was repeated every 6 hours while the subjects were awake for three days and the amount of the amino terminal procollagen I peptide (PINP) was determined; a marker of collagen synthesis, in the blood. Consistent with the hypothesis that gelatin increases collagen synthesis in humans; the amount of PINP in the 15 g gelatin group was significantly higher than either the placebo or the 5 g groups. These data conclusively demonstrate that gelatin supplementation can increase exercise-induced collagen synthesis in humans.

Similarly, supplementation with collagen hydrolysate has previously been shown to improve cartilage function in a randomized clinical trial in patients with osteoarthritis [9]. McAlindon and colleagues showed that consuming 10 g of collagen hydrolysate per day resulted in an increase in gadolinium enhanced MRI of collagen [9]. This finding suggests that the hydrolyzed collagen increased cartilage formation. In agreement with this finding, a 24-week randomized clinical trial in athletes showed that 10 g of GELITA® collagen hydrolysate significantly decreased knee pain. Mouse studies using C14 labeled hydrolyzed collagen hydrolysate demonstrated that >95% of the hydrolyzed collagen was absorbed in the first 12 hours after feeding. Interestingly, even though tracer from a separate C14 labeled proline could be incorporated into skin collagen at the same rate as tracer from hydrolyzed collagen, tracer from the hydrolyzed collagen was incorporated into the collagen of cartilage and muscle two-fold more than the tracer from proline. These data suggest that musculoskeletal collagen synthesis is greater in response to gelatin or hydrolyzed collagen than to the individual amino acids.

Even though the blood measure of PINP levels likely reflects bone collagen synthesis, using an engineered ligament model, a similar response has been demonstrated in tendons/ligaments treated with serum from people 1 hour after supplementation with gelatin. This work has shown that in the presence of serum isolated from the 5 and 15 grams of gelatin groups a step-wise increase in the collagen content of the ligaments. From this work, it can be ascertained that PINP can be used dependably as an indirect marker of collagen synthesis and that the changes observed in bone (blood levels) reflect what is occurring in other connective tissues as well.

The current study aims to precisely map out the dose response relationship of hydrolyzed collagen and vitamin C on PINP and to determine the optimal dose to achieve maximal increased in PINP levels. Secondly, whether this optimal dose of hydrolyzed collagen and vitamin C, taken before training is sufficient to improve RFD and performance will be determined. To achieve this goal, subjects will first consume increasing doses of hydrolyzed collagen (0 (control), 5, 10, 20 and 30 g) alongside a constant amount of vitamin C (50 mg). Once the optimal dose of hydrolyzed collagen is determined this dose will be administered with increasing doses of vitamin C (0 (control), 50, 250, 500 mg) to determine the optimal dose of vitamin C to maximize PINP levels. Both hydrolyzed collagen and vitamin C supplementation will be given 1 hour before 6 minutes of jump rope exercise.

After the optimal doses of hydrolyzed collagen and vitamin C are determined, the effects of the optimal dose of hydrolyzed collagen and vitamin C on performance will be assessed. Subjects will undergo an explosive/power-based exercise training program three days a week (Monday/Wednesday/Friday) for three weeks. The hydrolyzed collagen and vitamin C will be ingested 1 hour before each training session. Baseline exercise testing will take place at week 0, then exercise testing will occur on Friday of each week (week 1, 2 and 3). Subjects will undergo a series of tests to determine the RFD in the isometric squat, and countermovement and squat jump height.

Being tested
Hydrolyzed collagen, Vitamin C, Optimized Hydrolyzed Collagen and Vitamin C, Gummy Placebo
Keywords
collagen, tendon, procollagen type I N-terminal, athletes, vitamin C, hydrolyzed collagen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydrolyzed collagenDietary supplement

    Escalating dose of Hydrolyzed collagen

  • Vitamin CDietary supplement

    Escalating dose of Vitamin C

  • Optimized Hydrolyzed Collagen and Vitamin CDietary supplement

    combination of optimized doses of Hydrolyzed Collagen and Vitamin C

  • Gummy PlaceboDietary supplement

    Gummy placebo

Study groups in NCT03293004
Study groupRoleWhat they receive
Hydrolyzed collagenExperimentalFirst, we aim to determine the optimal amount of hydrolyzed collagen with a constant dose of vitamin C in humans to increase a marker of collagen synthesis (PINP). In a randomized, double-blinded, crossover design subjects consume a nutritional supplement with varying doses of hydrolyzed collagen (control (0 g), 5 10, 20 and 30 g hydrolyzed collagen) with a constant dose of vitamin C (50 mg). Each intervention will be separated by a 6-day wash out. Subjects will be asked to consume the supplement 1 hour before 6-min of jump rope exercise. Following completion of exercise, subjects will remain in the lab in a rested state for the subsequent 4 hours. After 4 hours and 24 hours blood samples will be collected. Blood samples will be used for PINP analysis.
Receives: Dietary Supplement: Hydrolyzed collagen
Vitamin CExperimentalSecond, we aim to determine the optimal amount of vitamin C with the determined optimal dose of hydrolyzed collagen in humans to increase a marker of collagen synthesis (PINP). In a randomized, double-blinded, crossover design subjects consume a nutritional supplement with varying doses of vitamin C (0 (control), 50, 250 and 500 mg) with an optimized dose of hydrolyzed collagen as determined from the first arm. Each intervention will be separated by a 6-day wash out. Subjects will be asked to consume the supplement 1 hour before 6-min of jump rope exercise. Following completion of exercise, subjects will remain in the lab in a rested state for the subsequent 4 hours. After 4 hours and 24 hours blood samples will be collected. Blood samples will be used for PINP analysis.
Receives: Dietary Supplement: Vitamin C
Optimized Collagen and Vitamin C supplementExperimentalThe findings from the first 2 arms of the study will be used to inform a training-based study aimed to determine whether exercise together with this optimal dose of hydrolyzed collagen and vitamin C is sufficient to improve rate of force development (RFD) and performance. A gummy food will be developed with the optimized dose of hydrolyzed collagen and vitamin C as well as a placebo. In a randomized, double-blinded, parallel design with subjects undertake a 3 week exercise protocol. The supplement will be ingested 1 hour prior to each exercise session (Monday/Wednesday/Friday). Exercise testing to assess rate of force development (RFD) will take place at the end of each week (Fridays) and these outcomes will be the basis for determining the effects of the nutrition intervention on performance.
Receives: Dietary Supplement: Optimized Hydrolyzed Collagen and Vitamin C
Gummy PlaceboPlacebo comparatorA gummy food will be developed with the optimized dose of hydrolyzed collagen and vitamin C as well as a placebo. In a randomized, double-blinded, parallel design with subjects undertake a 3 week exercise protocol. The supplement or placebo will be ingested 1 hour prior to each exercise session (Monday/Wednesday/Friday). Exercise testing to assess rate of force development (RFD) will take place at the end of each week (Fridays) and these outcomes will be the basis for determining the effects of the nutrition intervention on performance.
Receives: Dietary Supplement: Gummy Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PINP Levels

    To determine optimal dose of supplemental hydrolyzed collagen and vitamin C required to maximally elevate PINP levels (a marker of collagen synthesis) in healthy athletes.

    Measured: 9 weeks

  2. Rate of force development (RFD)

    a measure of explosive strength

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2017
  2. Study start13 Sep 2017
  3. Primary completion24 May 2018
  4. Study completion24 May 2018

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
A double blinded cross over design where subject are randomized to consume all 5 intervention doses.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03293004
Sponsor's protocol ID
1042848
Acronym
Collagen
Status last verified
Aug 2018
First submitted
15 Sep 2017
Last updated
21 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Hydrolyzed collagen, Vitamin C and Optimized Hydrolyzed Collagen and Vitamin C in people with Healthy Volunteers, 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 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 21 Aug 2018. 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?

PINP Levels (time frame: 9 weeks). The study lists 2 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 21 Aug 2018.

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