We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Vitamin C Enriched Hydrolyzed Collagen, PrimaColl™, Whey Protein, or Placebo on Collagen Synthesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05427279
Recruitment Status : Recruiting
First Posted : June 22, 2022
Last Update Posted : August 22, 2022
Sponsor:
Collaborator:
Geltor
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:

The purpose of this study is to determine the effects of repeated dosing vitamin C enriched hydrolyzed collagen (HC) over a 24hr period, compared to PrimaColl™ (PC), whey protein (WP) and placebo (PL), with prescribed exercise on collagen synthesis.

To achieve this, participants will consume a supplemental dose of HC (20g with 50mg vitamin C), PC (20g with 50mg vitamin C), whey protein (20g whey isolate with 50mg vitamin C) or a placebo (20g maltodextrin with 50mg vitamin C) 1hr prior to an exercise bout (6 minutes of jump rope), this will be repeated three times over a 24h period.

The amount of collagen protein synthesized will be indirectly measured by measuring pro-collagen type I N-terminal propeptide (PINP) in the serum before and 4hrs after the last exercise bout.


Condition or disease Intervention/treatment Phase
Effect of Food Supplement Dietary Supplement: Placebo Dietary Supplement: Hydrolized Collagen Dietary Supplement: PrimaColl Dietary Supplement: Whey protein Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will consume a supplemental dose of hydrolyzed collagen (20g with 50mg vitamin C), PrimaColl (20g with 50mg vitamin C), whey protein (20g whey isolate with 50mg vitamin C) or a placebo (20g maltodextrin with 50mg vitamin C) 1hr prior to exercise bouts (6 minutes of jump rope). The type of consumed supplementation will be randomized where neither the participant nor investigator will know which supplement is being consumed. Each participant will repeat the protocol four times.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: A randomized double-blind crossover design with neither the subjects nor the investigators knowing who is on which treatment. The interventions will be coded using a blinded alphabetical letter code (A, B, C, D). A delegate researcher (independent party not further involved in the study) will randomize all interventions using a computer-generated randomization list. The delegate will hand in the code-breaker to the principal investigator in a sealed envelope. The envelope will be stored in a locked filing cabinet in the principal investigator's office, which will also be locked when unoccupied. The envelope will be opened by the principal investigator after completing the analysis of blood samples.
Primary Purpose: Other
Official Title: Investigating the Effects of 24-hours of Repeated Doses of Vitamin C Enriched Hydrolyzed Collagen, PrimaColl™, Whey Protein, or Placebo on Collagen Synthesis
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C
Drug Information available for: Collagen

Arm Intervention/treatment
Placebo Comparator: Placebo
This arm will be given a placebo (20g maltodextrin with 50mg vitamin C)
Dietary Supplement: Placebo
The participant will consume a supplemental dose of a placebo (20g maltodextrin with 50mg vitamin C)
Other Name: maltodextrin

Experimental: Hydrolized Collagen
This arm will be given Hydrolized Collagen (20g with 50mg vitamin C)
Dietary Supplement: Hydrolized Collagen
The participant will consume a supplemental dose of Hydrolized collagen (20g with 50mg vitamin C)

Experimental: PrimaColl
This arm will be given PrimaColl, a vegan collagen supplementation (20g with 50mg vitamin C)
Dietary Supplement: PrimaColl
The participant will consume a supplemental dose of PrimaColl, a vegan collagen supplementation (20g with 50mg vitamin C)

Experimental: Whey Protein
This arm will be given whey protein (20g with 50mg vitamin C)
Dietary Supplement: Whey protein
The participant will consume a supplemental dose of whey protein (20g whey isolate with 50mg vitamin C)




Primary Outcome Measures :
  1. Collagen protein synthesis [ Time Frame: Baseline (0 hour) to 4 hours after last exercise bout (at 28 hour of the protocol) ]
    Collagen protein synthesis will be indirectly measured by measuring pro-collagen type I N-terminal propeptide (PINP) in the serum before and 4 hours after the last exercise bout (at 28 hours of the protocol)


Secondary Outcome Measures :
  1. Ligament collagen content [ Time Frame: Baseline (0 hour) to directly after consumption of supplementation (1 hour) ]
    Serum from participants will be used to treat engineered ligaments in order to assess the effect of the different supplementation on the ligament collagen content using a hydroxyproline assay kit.

  2. Strength of engineered ligaments [ Time Frame: Baseline (0 hour) to directly after consumption of supplementation (1 hour) ]
    Serum from participants will be used to treat engineered ligaments in order to measure the effect of the different supplementation on the strength of the ligaments, the strength will be measured using the Instron bio puls 68SC-1 tension and compression machine.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy active male or female
  • normal weight (BMI between 18 and 25 kg/m2)

Exclusion Criteria:

  • taking any medication that may interfere with the study
  • have a history of more than 3 musculoskeletal injuries within the past 12 months
  • have any health or dietary restriction that would be affected by the supplementation protocol

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): NCT05427279


Contacts
Layout table for location contacts
Contact: Emelie Strandberg, PhD +15307049253 ekstandberg@ucdavis.edu
Contact: Keith Baar, PhD kbaar@ucdavis.edu

Locations
Layout table for location information
United States, California
Hickey Laboratory Recruiting
Davis, California, United States, 95616
Contact: Emelie Strandberg, PhD    530-704-9253    ekstrandberg@ucdavis.edu   
Contact: Keith Baar, PhD    +15304002188    kbaar@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Geltor
Investigators
Layout table for investigator information
Principal Investigator: Keith Baar, PhD UC Davis
Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT05427279    
Other Study ID Numbers: 220518
First Posted: June 22, 2022    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022

Layout table for additional information
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 synthesis
Exercise
Supplementation
Engineered ligaments