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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
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Dietary Supplement: Hydrolyzed collagen Dietary Supplement: Vitamin C Dietary Supplement: Optimized Hydrolyzed Collagen and Vitamin C Dietary Supplement: Gummy Placebo Not Applicable

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arm Intervention/treatment
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.
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.
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.
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.
Dietary Supplement: Gummy Placebo
Gummy placebo




Primary Outcome Measures :
  1. 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.

  2. Rate of force development (RFD) [ Time Frame: 3 weeks ]
    a measure of explosive strength



Information from the National Library of Medicine

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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
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, California
University of California Davis
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03293004     History of Changes
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
collagen
tendon
procollagen type I N-terminal
athletes
vitamin C
hydrolyzed collagen
Additional relevant MeSH terms:
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Vitamins
Ascorbic Acid
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents