NCT07119749

Brief Summary

This study will be a randomised, double-blind trial where participants will be randomly assigned to consume either a i) vegan whey protein; ii) a whey protein; or iii) a non-protein carbohydrate control supplement for 3 days following strenuous eccentric knee extension exercise. For the duration of the study period, participants will orally consume deuterated water stable isotope tracer (D2O). This, together with repeated blood sampling and muscle biopsies will allow for the calculation of free-living myofibrillar protein synthesis rates under conditions of rest and over 24-, 48- and 72-hours post-exercise recovery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

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

Study Start

First participant enrolled

September 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
Last Updated

August 13, 2025

Status Verified

April 1, 2025

Enrollment Period

1.2 years

First QC Date

May 6, 2025

Last Update Submit

August 5, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Myofibrillar protein synthesis rates (iMyoPS)

    1\. Changes in myofibrillar protein synthesis rates of the exercised leg, both over time (1, 24, 48 and 72 hours) during post-exercise recovery and between supplemental groups (vegan whey, whey protein, and non-protein carbohydrate control). Determined by assessing the incorporation of deuterium in muscle, relative to saliva and blood deuterium enrichment.

    3 days pre-exercise and 3 days post-exercise

  • Muscle function

    4\. Changes in leg muscle architecture followed by leg strength and neural activation will be assessed pre- and at 1, 8-, 24-, 48- and 72-hours post-exercise. Muscle architecture will be assessed using ultrasound and specifically, shear-wave elastography. Change in isometric strength will be assessed on a Biodex dynamometer at a set knee angle while simultaneously assessing neural activation. Participants will be asked to perform a maximal voluntary contraction (MVC) for 5 seconds while neural activation is measured using the interpolated twitch method. There will be 3 measurements for MVC and neural activation with 2 minutes rest between each attempt on visit

    pre- and 1, 4, 24, 48 and 72 hr post-exercise

  • Intramuscular anabolic signalling

    2\. Changes in the total protein content and phosphorylation status of key anabolic signalling proteins, both over time post-exercise and between the supplemental groups. Assessed by Western Blotting of muscle biopsy samples

    pre- and 1-hr and 24-hr post-exercise

  • Muscle morphology

    3\. Changes in muscle structure and morphology at pre- and at 1, 24-, 48- and 72-hours post-exercise will be assessed via immunofluorescence microscopy of muscle biopsy samples.

    pre- and 1, 24, 48 and 72 hr post-exercise

Secondary Outcomes (2)

  • Muscle soreness

    pre- and 1, 4, 24, 48 and 72 hr post-exercise

  • Blood markers of muscle damage

    pre- and 1, 4, 24, 48 and 72 hr post-exercise

Study Arms (3)

Vegan whey protein

EXPERIMENTAL

3 x daily supplementation of 0.3 g per kg body mass of vegan whey protein isolate for 3 days following an acute bout of lower-body unilateral resistance exercise

Other: Stable isotope tracer consumptionRadiation: DXA scanBehavioral: Controlled dietOther: Saliva sampleOther: Blood sampleProcedure: Muscle biopsyBehavioral: Resistance exerciseOther: Isometric strength testDietary Supplement: Supplement

Dairy whey protein

ACTIVE COMPARATOR

3 x daily supplementation of 0.3 g per kg body mass of dairy whey protein isolate for 3 days following an acute bout of lower-body unilateral resistance exercise

Other: Stable isotope tracer consumptionRadiation: DXA scanBehavioral: Controlled dietOther: Saliva sampleOther: Blood sampleProcedure: Muscle biopsyBehavioral: Resistance exerciseOther: Isometric strength testDietary Supplement: Supplement

Carbohydrate placebo

PLACEBO COMPARATOR

3 x daily supplementation of isocaloric carbohydrate placebo for 3 days following an acute bout of lower-body unilateral resistance exercise

Other: Stable isotope tracer consumptionRadiation: DXA scanBehavioral: Controlled dietOther: Saliva sampleOther: Blood sampleProcedure: Muscle biopsyBehavioral: Resistance exerciseOther: Isometric strength testDietary Supplement: Supplement

Interventions

Daily consumption of oral deuterium oxide (0.3 ml per kg of lean body mass) to equilibrate in body water and become slowly incorporated into muscle protein, enabling measurement of muscle protein synthesis rates

Carbohydrate placeboDairy whey proteinVegan whey protein
DXA scanRADIATION

Whole body DXA scan to assess lean body mass for prescription of deuterium oxide tracer

Carbohydrate placeboDairy whey proteinVegan whey protein
Controlled dietBEHAVIORAL

Participant will be asked to consume a provided 6-day diet package that will be prepared by the research team. This package will include 3 meals per day plus snacks

Carbohydrate placeboDairy whey proteinVegan whey protein

Obtained from participants by asking them to spit into a tube each day during the study, for 11 days in total.

Carbohydrate placeboDairy whey proteinVegan whey protein

Resting venous blood sample from a forearm vein on 6 separate occasions

Carbohydrate placeboDairy whey proteinVegan whey protein
Muscle biopsyPROCEDURE

A highly experienced researcher will sample a small section of muscle (\~200 mg) from the vastus lateralis muscle under local anaesthetic (5 ml, 1% Lidocaine)

Carbohydrate placeboDairy whey proteinVegan whey protein

participants will complete 8 sets of 10 repetitions of unilateral eccentric knee extensions on an isokinetic dynamometer.

Carbohydrate placeboDairy whey proteinVegan whey protein

Bilateral isometric strength will be measured using a well-established protocol on an isokinetic dynamometer.

Carbohydrate placeboDairy whey proteinVegan whey protein
SupplementDIETARY_SUPPLEMENT

Consumption of 3 supplements a day for 3 days following resistance exercise. All supplements are commercially available.

Carbohydrate placeboDairy whey proteinVegan whey protein

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males, and females aged 18-40 years with a body mass index between 18.5 and 29.9 kg/m2
  • Healthy individuals free from metabolic and respiratory disease
  • Recreationally active or trained (complete at least 150 mins of moderate physical activity, or 75 mins of vigorous physical activity per week, identify with a certain sport, intend to compete in local competition)
  • Understands and is willing, able and likely to comply with all study procedures and restrictions
  • Demonstrates an understanding of the study and willingness to participate, as evidenced by voluntary written informed consent

You may not qualify if:

  • Aged \<18 or \>40 years
  • Pregnancy and Breastfeeding
  • Body mass index \<18.5 or \>29.9 kg/m2
  • Regular participation (i.e., \>3 times weekly for the previous 3 months) in structured exercise or sport with a large eccentric component, such as trail running, soccer, basketball etc.
  • Elite athletes or sports-people who compete nationally or internationally
  • Habitual smokers
  • History of respiratory or metabolic disease
  • Any allergies or intolerances to the study materials, protein supplements and food ingredients to be used in this study. In particular, those with an allergy to lidocaine and lactose will be excluded
  • Use of any medication or supplements known to affect muscle protein metabolism (e.g., beta-blockers, corticosteroids, analgesics, or non-steroidal anti-inflammatories). Additional medications and/or supplementation aids (e.g., vitamins) will be deemed inappropriate based on the PI's discretion
  • Any current or history of musculoskeletal injury
  • Any history of medical or surgical events that may affect the study outcomes
  • Previous participation in a research-based exercise protocol designed to induce severe muscle damage in the last 6 months
  • Habitual protein intakes \<0.8 g/kg body mass/day or \> 2.2 g/kg body mass/day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham

Birmingham, West Midlands, B15 2TT, United Kingdom

Location

MeSH Terms

Conditions

Myalgia

Interventions

Absorptiometry, PhotonBlood Specimen CollectionResistance TrainingDietary Supplements

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesSpecimen HandlingClinical Laboratory TechniquesPuncturesSurgical Procedures, OperativeExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2025

First Posted

August 13, 2025

Study Start

September 1, 2023

Primary Completion

November 22, 2024

Study Completion

November 22, 2024

Last Updated

August 13, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations