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Gelatin, Collagen, Gummy and PINP

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ClinicalTrials.gov Identifier: NCT03357432
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : November 9, 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 determine is the same dose of gelatin, hydrolyzed collagen and a gelatin/collagen mix, all with a standard dose of vitamin C effect PINP levels similarly.

Condition or disease Intervention/treatment Phase
Collagen Synthesis Other: gelatin, collagen, gummy dose Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: A crossover design where subject are randomized to consume all 3 intervention doses.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Determining Whether Gelatin, Hydrolyzed Collagen and Gelatin/Collagen Mixture Have Similar Effects on Collagen Synthesis
Actual Study Start Date : October 21, 2017
Actual Primary Completion Date : September 7, 2018
Actual Study Completion Date : September 7, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: effects of gelatin, collagen on PINP levels
The study is aimed at determining if the same dose of gelatin, hydrolyzed collagen (administered in a beverage form) or a mixture gelatin/hydrolyzed collagen (administered in a gummy form) with a standard dose of vitamin C (50 mg) has a similar effect a marker of collagen synthesis (PINP). In a randomized, crossover design subjects consume 3 different nutritional supplements: (a) 15 of gelatin, (b) 15 hydrolyzed collagen (administered in a beverage form) or (c) 15 g of gelatin/hydrolyzed collagen mixture all with a standard dose of vitamin C (50 mg) 1 hour prior to exercise stimulus (6 minutes of jump rope). A baseline assessment with only the jump rope and no intervention will also be conducted prior to the interventions. Each intervention will be separated by a >24 hr washout. Following completion of exercise, subjects will remain in the lab in a rested state for the subs
Other: gelatin, collagen, gummy dose
The study is aimed at determining if the same dose of gelatin, hydrolyzed collagen (administered in a beverage form) or a mixture gelatin/hydrolyzed collagen (administered in a gummy form) with a standard dose of vitamin C (50 mg) has a similar effect a marker of collagen synthesis (PINP). In a randomized, crossover design subjects consume 3 different nutritional supplements: (a) 15 of gelatin, (b) 15 hydrolyzed collagen (administered in a beverage form) or (c) 15 g of gelatin/hydrolyzed collagen mixture all with a standard dose of vitamin C (50 mg) 1 hour prior to exercise stimulus (6 minutes of jump rope). A baseline assessment with only the jump rope and no intervention will also be conducted prior to the interventions. Each intervention will be separated by a >24 hr washout. Following completion of exercise, subjects will remain in the lab in a rested state for the subsequent 4 hours. After 4 hours blood samples will be collected. Blood samples will be used for PINP analysis.




Primary Outcome Measures :
  1. PINP levels [ Time Frame: 4 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   male healthy active
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Recreationally active male athletes between the ages of 18-50 years of age training 5-6 days per week including at least 1 training session of running per week.

Exclusion Criteria:

  • Receiving any medication that may interfere with the study.
  • History of more than 3 musculoskeletal injuries within the past 12 months.
  • Health or dietary restriction that would be affected by the supplementation protocol.
  • The initial phases of this study will be performed in males since collagen synthesis varies significantly throughout the menstrual cycle in females. Since collagen is 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 process with similar research 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): NCT03357432


Locations
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United States, California
Biological Sciences
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: NCT03357432    
Other Study ID Numbers: 1140867
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 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
gelatin
PINP