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

NCT05427279 | Completed

• 1 other identifier: 220518
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Effect of Food Supplement

Keywords

Collagen synthesis; Exercise; Supplementation; Engineered ligaments

Outcome Measures

Primary Outcomes (1)

• Collagen protein synthesis

  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)

  Baseline (0 hour) to 4 hours after last exercise bout (at 28 hour of the protocol)

Secondary Outcomes (2)

• Ligament collagen content

  Baseline (0 hour) to directly after consumption of supplementation (1 hour)

• Strength of engineered ligaments

  Baseline (0 hour) to directly after consumption of supplementation (1 hour)

Study Arms (4)

Placebo

PLACEBO COMPARATOR

This arm will be given a placebo (20g maltodextrin with 50mg vitamin C)

Dietary Supplement: Placebo

Hydrolized Collagen

EXPERIMENTAL

This arm will be given Hydrolized Collagen (20g with 50mg vitamin C)

Dietary Supplement: Hydrolized Collagen

PrimaColl

EXPERIMENTAL

This arm will be given PrimaColl, a vegan collagen supplementation (20g with 50mg vitamin C)

Dietary Supplement: PrimaColl

Whey Protein

EXPERIMENTAL

This arm will be given whey protein (20g with 50mg vitamin C)

Dietary Supplement: Whey protein

Interventions

Placebo DIETARY_SUPPLEMENT

The participant will consume a supplemental dose of a placebo (20g maltodextrin with 50mg vitamin C)

Also known as: maltodextrin

Placebo

Hydrolized Collagen DIETARY_SUPPLEMENT

The participant will consume a supplemental dose of Hydrolized collagen (20g with 50mg vitamin C)

Hydrolized Collagen

PrimaColl DIETARY_SUPPLEMENT

The participant will consume a supplemental dose of PrimaColl, a vegan collagen supplementation (20g with 50mg vitamin C)

PrimaColl

Whey protein DIETARY_SUPPLEMENT

The participant will consume a supplemental dose of whey protein (20g whey isolate with 50mg vitamin C)

Whey Protein

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Geltor: collaborator

Study Sites (1)

Hickey Laboratory

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

maltodextrin; Whey Proteins

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Keith Baar, PhD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 22, 2022
• Study Start: October 5, 2022
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

US (1)