NCT05425407

Brief Summary

The aim of the study is to investigate the acute and short-term effects of collagen peptides (Collagen Peptan) on muscle and connective tissue during an eccentric overload training period. Currently, all studies investigating the effects of post-exercise collagen supplementation did this in the absence of whey proteins, which are part of the standard recommendations for post-exercise recovery. The investigators will therefore investigate whether the combined intake of whey proteins and collagen peptides ensures a better recovery of exercise performance and whether it can prevent or reduce symptoms of muscle and tendon overload during a three-week eccentric overload training period (n = 22).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

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

April 12, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2021

Completed
11 months until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

August 3, 2021

Last Update Submit

June 16, 2022

Conditions

Keywords

Whey proteinCollagen peptideMuscle and tendon overload training

Outcome Measures

Primary Outcomes (4)

  • Change in countermovement jump performance

    Change in jump height when performing a countermovement jump, measured via a force platform

    Pretest - 48 hours after the first training session (day 3 of training intervention) - Posttest (day 22 of training intervention)

  • Change in maximal isometric knee-extension force of the right leg

    Change in maximal isometric knee-extension force (angle = 45°) of the right leg

    Pretest - 48 hours after the first training session (day 3 of training intervention) - Posttest (day 22 of training intervention)

  • Change in anteroposterior thickness of the right patellar tendon

    Change in anteroposterior thickness of the right patellar tendon

    Pretest - 48 hours after the first training session (day 3 of training intervention) - Posttest (day 22 of training intervention)

  • Change in neovascularization of the right patellar tendon

    Neovascularization of the right patellar tendon scored with the Modified Ohberg Score (range 0 - 4; the higher the score, the higher the degree of neovascularization).

    Pretest - 48 hours after the first training session (day 3 of training intervention) - Posttest (day 22 of training intervention)

Secondary Outcomes (5)

  • Change in pain perception at the muscular level (VAS scale)

    Training 1 (day 1 of training intervention) - Training 2 (day 3 of training intervention) - Training 8 (day 9 of training intervention) - Training 17 (day 19 of training intervention) - Posttest (day 22 of training intervention)

  • Change in pain perception of the patellar tendon of the right leg (VISA-P)

    Pretest - Training 1 (day 1 of training intervention) - Training 17 (day 21 of training intervention) - Posttest (day 22 of training intervention)

  • Change in the blood concentration of creatine kinase

    Pretest - Training 2 (day 3 of training intervention) - Posttest (day 22 of training intervention)

  • Change in the blood concentration of Interleukin 6 (IL-6)

    Pretest - Training 2 (day 3 of training intervention) - Posttest (day 22 of training intervention)

  • Change in the blood concentration of N-terminal propeptide of type I procollagen (P1NP)

    Pretest - Training 2 (day 3 of training intervention) - Posttest (day 22 of training intervention)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Only whey protein will be provided

Dietary Supplement: whey protein

Collagen

EXPERIMENTAL

A mix of whey protein and collagen peptides will be provided

Dietary Supplement: whey protein + collagen peptide

Interventions

whey proteinDIETARY_SUPPLEMENT

Daily 45g of whey protein supplementation during a three week eccentric training period

Placebo

Daily 15g of whey protein and 20g collagen peptide supplementation during a three week eccentric training period

Collagen

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Sports participation, including general fitness training, between 2 and 5 hours max per week
  • Body mass index between 18.5 and 25

You may not qualify if:

  • Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise - Intake of any medication or nutritional supplement that could impact muscle protein synthesis and/or exercise performance during the period of the study
  • Intake of any whey protein, casein of branched-chain amino acid (BCAA) supplements from 1 month prior to the start of the study
  • Blood donation within 3 months prior to the start of the study
  • Smoking
  • Current participation in another research trial
  • Any other argument to believe that the subject is unlikely to successfully complete the full study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Physiology Research Group

Leuven, Vlaams-Brabant, 3001, Belgium

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2021

First Posted

June 21, 2022

Study Start

April 12, 2021

Primary Completion

May 30, 2021

Study Completion

June 30, 2021

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations