Vegan Whey Protein for Muscle Anabolism and Post-exercise Recovery

August 5, 2025 updated by: University of Birmingham

The Effects of Ingesting Vegan-friendly Whey Protein on Muscle Anabolism and Recovery Following Damaging Eccentric Resistance Exercise

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will be asked to attend 7 experimental visits at the School of Sport, Exercise and Rehabilitation Sciences at the University of Birmingham. The first of the 7 visits will be to assess participant eligibility and to gain written informed consent, where the remaining 6 visits will involve experimental procedures. Briefly, participants will be randomly assigned to ingest one of three nutritional supplements (i: vegan whey protein isolate; ii: whey protein isolate; iii: a non-protein carbohydrate control), 3 times a day for a total of 3 days following an acute bout of unilateral lower-limb eccentric exercise. The study will be run in a double-blinded fashion, where the researchers and participants will both be unaware of nutritional treatment allocation. The amount of protein in each supplemental beverage is prescribed based on total body mass (0.3 g of protein per kg of body mass). As well, for 3 days before and 3 days after the exercise bout, participants will be provided with a standardised diet to consume. For the 3 days before the exercise bout, all participants will consume an identical diet, with a protein intake of 1 g per kg body mass and diets will be energy-matched between treatment groups. For the subsequent 3 days, participants assigned to each of the protein supplementation groups (whey protein or vegan whey protein) will have a daily protein intake of 1.9 g per kg body mass, whereas participants assigned to the carbohydrate control group will maintain protein intake at 1 g per kg body mass. Measures of muscle function, soreness and thickness will be taken before and at various time points after the eccentric exercise, details of which can be found below. To assess the muscle protein synthetic response to each nutritional treatment, participants will orally consume a stable isotope tracer ("heavy water") for a period of 9 days, and muscle biopsies and saliva samples will be taken periodically. An outline of each experimental visit is outlined below.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TT
        • School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vegan whey protein
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 consumption
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
Radiation: DXA scan
Whole body DXA scan to assess lean body mass for prescription of deuterium oxide tracer
Behavioral: Controlled diet
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
Other: Saliva sample
Obtained from participants by asking them to spit into a tube each day during the study, for 11 days in total.
Other: Blood sample
Resting venous blood sample from a forearm vein on 6 separate occasions
Procedure: Muscle biopsy
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)
Behavioral: Resistance exercise
participants will complete 8 sets of 10 repetitions of unilateral eccentric knee extensions on an isokinetic dynamometer.
Other: Isometric strength test
Bilateral isometric strength will be measured using a well-established protocol on an isokinetic dynamometer.
Dietary supplement: Supplement
Consumption of 3 supplements a day for 3 days following resistance exercise. All supplements are commercially available.
Active Comparator: Dairy whey protein
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 consumption
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
Radiation: DXA scan
Whole body DXA scan to assess lean body mass for prescription of deuterium oxide tracer
Behavioral: Controlled diet
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
Other: Saliva sample
Obtained from participants by asking them to spit into a tube each day during the study, for 11 days in total.
Other: Blood sample
Resting venous blood sample from a forearm vein on 6 separate occasions
Procedure: Muscle biopsy
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)
Behavioral: Resistance exercise
participants will complete 8 sets of 10 repetitions of unilateral eccentric knee extensions on an isokinetic dynamometer.
Other: Isometric strength test
Bilateral isometric strength will be measured using a well-established protocol on an isokinetic dynamometer.
Dietary supplement: Supplement
Consumption of 3 supplements a day for 3 days following resistance exercise. All supplements are commercially available.
Placebo Comparator: Carbohydrate placebo
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 consumption
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
Radiation: DXA scan
Whole body DXA scan to assess lean body mass for prescription of deuterium oxide tracer
Behavioral: Controlled diet
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
Other: Saliva sample
Obtained from participants by asking them to spit into a tube each day during the study, for 11 days in total.
Other: Blood sample
Resting venous blood sample from a forearm vein on 6 separate occasions
Procedure: Muscle biopsy
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)
Behavioral: Resistance exercise
participants will complete 8 sets of 10 repetitions of unilateral eccentric knee extensions on an isokinetic dynamometer.
Other: Isometric strength test
Bilateral isometric strength will be measured using a well-established protocol on an isokinetic dynamometer.
Dietary supplement: Supplement
Consumption of 3 supplements a day for 3 days following resistance exercise. All supplements are commercially available.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Myofibrillar protein synthesis rates (iMyoPS)
Time Frame: 3 days pre-exercise and 3 days post-exercise
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
Time Frame: pre- and 1, 4, 24, 48 and 72 hr post-exercise
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
Time Frame: pre- and 1-hr and 24-hr post-exercise
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
Time Frame: pre- and 1, 24, 48 and 72 hr post-exercise
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle soreness
Time Frame: pre- and 1, 4, 24, 48 and 72 hr post-exercise
Subjective ratings of muscle soreness will be measured via completion of validated visual analogue scales (no muscle soreness 0 - worst imaginable muscle soreness 100 mm)
pre- and 1, 4, 24, 48 and 72 hr post-exercise
Blood markers of muscle damage
Time Frame: pre- and 1, 4, 24, 48 and 72 hr post-exercise
Plasma concentrations of systemic markers of muscle damage (creatine kinase, lactate dehydrogenase etc) will be measured from blood samples
pre- and 1, 4, 24, 48 and 72 hr post-exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RG_21-198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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