Collagen Vitamin C Dose Response Performance (Collagen)
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ClinicalTrials.gov Identifier: NCT03293004 |
Recruitment Status :
Completed
First Posted : September 26, 2017
Last Update Posted : August 21, 2018
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Condition or disease | Intervention/treatment | Phase |
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Healthy Volunteers | Dietary Supplement: Hydrolyzed collagen Dietary Supplement: Vitamin C Dietary Supplement: Optimized Hydrolyzed Collagen and Vitamin C Dietary Supplement: Gummy Placebo | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | A double blinded cross over design where subject are randomized to consume all 5 intervention doses. |
Masking: | Double (Participant, Investigator) |
Masking Description: | All nutritional interventions taste and look similar and are prepared for subjects in opaque bottles |
Primary Purpose: | Treatment |
Official Title: | Effects of Hydrolyzed Collagen and Vitamin C on Collagen Synthesis and Explosive Performance |
Actual Study Start Date : | September 13, 2017 |
Actual Primary Completion Date : | May 24, 2018 |
Actual Study Completion Date : | May 24, 2018 |
Arm | Intervention/treatment |
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Experimental: Hydrolyzed collagen
First, 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.
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Dietary Supplement: Hydrolyzed collagen
Escalating dose of Hydrolyzed collagen |
Experimental: Vitamin C
Second, 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.
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Dietary Supplement: Vitamin C
Escalating dose of Vitamin C |
Experimental: Optimized Collagen and Vitamin C supplement
The 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.
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Dietary Supplement: Optimized Hydrolyzed Collagen and Vitamin C
combination of optimized doses of Hydrolyzed Collagen and Vitamin C |
Placebo Comparator: Gummy Placebo
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 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.
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Dietary Supplement: Gummy Placebo
Gummy placebo |
- PINP Levels [ Time Frame: 9 weeks ]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.
- Rate of force development (RFD) [ Time Frame: 3 weeks ]a measure of explosive strength

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Ages Eligible for Study: | 18 Years to 25 Years (Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Male 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. |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293004
United States, California | |
University of California Davis | |
Davis, California, United States, 95616 |
Responsible Party: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT03293004 |
Other Study ID Numbers: |
1042848 |
First Posted: | September 26, 2017 Key Record Dates |
Last Update Posted: | August 21, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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