NCT03357432

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 23, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2018

Completed
Last Updated

November 9, 2018

Status Verified

November 1, 2018

Enrollment Period

11 months

First QC Date

November 23, 2017

Last Update Submit

November 7, 2018

Conditions

Keywords

collagengelatinPINP

Outcome Measures

Primary Outcomes (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.

    4 weeks

Study Arms (1)

effects of gelatin, collagen on PINP levels

EXPERIMENTAL

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

Interventions

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.

effects of gelatin, collagen on PINP levels

Eligibility Criteria

Age18 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale healthy active
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biological Sciences

Davis, California, 95616, United States

Location

MeSH Terms

Interventions

GelatinCollagen

Intervention Hierarchy (Ancestors)

ScleroproteinsProteinsAmino Acids, Peptides, and ProteinsBiopolymersPolymersMacromolecular SubstancesExtracellular Matrix Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: A crossover design where subject are randomized to consume all 3 intervention doses.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2017

First Posted

November 29, 2017

Study Start

October 21, 2017

Primary Completion

September 7, 2018

Study Completion

September 7, 2018

Last Updated

November 9, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations