NCT05386771

Brief Summary

Rationale: Protein ingestion stimulates muscle protein synthesis and augments the muscle protein synthetic response to a single exercise session. In support, protein supplementation has been shown to augment the gains in muscle mass and strength following resistance exercise training. The force generated by contracting muscle is transferred through a network of connective tissue proteins towards the bone. Consequently, remodeling of skeletal muscle connective tissue represents an essential component of skeletal muscle adaptation to exercise. The anabolic effect of a protein supplement is mainly determined by the plasma amino acid response after ingestion. Although whey protein is considered the preferred protein source to maximize myofibrillar protein synthesis rates, it contains insufficient glycine and proline to support the post-exercise increase in connective tissue protein synthesis rates. In contrast, collagen protein is rich in glycine and proline and has, therefore, been proposed as a preferred protein source to support connective tissue remodeling. Hence, the combined ingestion of whey plus collagen protein may therefore be preferred to stimulate both myofibrillar and collagen protein synthesis rates in skeletal muscle tissue. The most ideal protein supplement for stimulating both myofibrillar and collagen protein synthesis is one that gives a rapid initial rise in plasma amino acid concentrations including leucine, proline and glycine concentrations. However, the effect a blend of whey and collagen protein on myofibrillar and connective tissue protein synthesis rates is unknown. Objective: To assess the effect of a whey and collagen protein blend versus a placebo on myofibrillar and connective tissue protein synthesis rates in muscle obtained during recovery from exercise and rest in vivo in humans. Study design: Double-blind, parallel-group, placebo-controlled intervention study. Study population: 28 healthy recreationally active males (18-35 y; BMI: 18.5-30 kg/m2). Intervention: Participants will perform unilateral resistance exercise followed by the ingestion of either a blend of 25 g whey and 5 g collagen protein or a non-caloric placebo (flavored water). Continuous intravenous stable isotope amino acid tracer infusions will be applied, and plasma and muscle samples will be collected in order to assess protein synthesis rates in muscle tissue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 6, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2023

Completed
Last Updated

July 19, 2023

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

May 18, 2022

Last Update Submit

July 18, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Muscle protein synthesis rates exercised leg

    Muscle protein synthesis rates are calculated using L-ring-13C6-phenylalanine tracer and provided as 1 integrated value over the specified timeframe using plasma as precursor of the exercised leg.

    0-5 hours

  • Muscle protein synthesis rates rested leg

    Muscle protein synthesis rates are calculated using L-ring-13C6-phenylalanine tracer and provided as 1 integrated value over the specified timeframe using plasma as precursor of the rested leg.

    0-5 hours

Secondary Outcomes (4)

  • Muscle protein synthesis rates

    -3-0 hours

  • Plasma glucose concentrations

    0-5 hours

  • Plasma insulin concentrations

    0-5 hours

  • Plasma amino acids concentrations

    0-5 hours

Other Outcomes (8)

  • Age

    baseline

  • Dietary macronutrient intake

    2 days before test days

  • Body mass in kg

    baseline

  • +5 more other outcomes

Study Arms (2)

Whey and collagen protein blend

EXPERIMENTAL

A blend of 25g of whey protein and 5g of collagen protein

Dietary Supplement: Whey/collagen protein blendBehavioral: Resistance exercise

Placebo

PLACEBO COMPARATOR

Water, same volume as the experimental study beverage

Dietary Supplement: Whey/collagen protein blendBehavioral: Resistance exercise

Interventions

Whey/collagen protein blendDIETARY_SUPPLEMENT

Ingestion of 30g of protein dissolved in 300ml water consumed after an exercise session

PlaceboWhey and collagen protein blend

A single resistance exercise session of the leg press and leg extension exercise

PlaceboWhey and collagen protein blend

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males
  • Aged between 18-35 years
  • Healthy, recreationally active (performing exercise 3 times per week or less in the past 6 months)
  • BMI 18.5 - 30 kg/m2
  • No physical limitations (i.e. able to perform all activities associated with daily living in an independent manner).

You may not qualify if:

  • Females
  • Musculoskeletal disorders
  • Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
  • Participation in any structured regular exercise program
  • Chronic use of gastric acid suppressing medication or anti-coagulants
  • Pathologies of the gastrointestinal tract
  • Blood donation in the past 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre+

Maastricht, Limburg, 6229ER, Netherlands

Location

Related Publications (1)

  • Aussieker T, Kaiser J, Hermans WJH, Hendriks FK, Holwerda AM, Senden JM, VAN Kranenburg JMX, Goessens JPB, Braun U, Baar K, Snijders T, VAN Loon LJC. Ingestion of a Whey Plus Collagen Protein Blend Increases Myofibrillar and Muscle Connective Protein Synthesis Rates. Med Sci Sports Exerc. 2025 Mar 1;57(3):544-554. doi: 10.1249/MSS.0000000000003596. Epub 2024 Nov 6.

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Randomized double-blind
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Double-blind, parallel-group, placebo-controlled intervention study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 23, 2022

Study Start

September 6, 2022

Primary Completion

April 3, 2023

Study Completion

April 3, 2023

Last Updated

July 19, 2023

Record last verified: 2022-09

Locations