Muscle SorenessNCT07119749
Vegan Whey Protein for Muscle Anabolism and Post-exercise Recovery
A study testing Stable isotope tracer consumption, DXA scan and Saliva sample in people with Muscle Soreness, run by University of Birmingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Soreness
- What is being tested?
- Stable isotope tracer consumption, DXA scan and Saliva sample
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2023to 22 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham
Birmingham, West Midlands, B15 2TT
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle Soreness
- Being tested
- Stable isotope tracer consumption, DXA scan, Controlled diet, Saliva sample, Blood sample
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stable isotope tracer consumptionOther
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
DXA scanRadiation
Whole body DXA scan to assess lean body mass for prescription of deuterium oxide tracer
Controlled dietBehavioural
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
Saliva sampleOther
Obtained from participants by asking them to spit into a tube each day during the study, for 11 days in total.
Blood sampleOther
Resting venous blood sample from a forearm vein on 6 separate occasions
Muscle biopsyProcedure or surgery
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)
Resistance exerciseBehavioural
participants will complete 8 sets of 10 repetitions of unilateral eccentric knee extensions on an isokinetic dynamometer.
Isometric strength testOther
Bilateral isometric strength will be measured using a well-established protocol on an isokinetic dynamometer.
SupplementDietary supplement
Consumption of 3 supplements a day for 3 days following resistance exercise. All supplements are commercially available.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Stable isotope tracer consumption; Radiation: DXA scan; Behavioral: Controlled diet; Other: Saliva sample; Other: Blood sample; Procedure: Muscle biopsy; Behavioral: Resistance exercise; Other: Isometric strength test; Dietary 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 Receives: Other: Stable isotope tracer consumption; Radiation: DXA scan; Behavioral: Controlled diet; Other: Saliva sample; Other: Blood sample; Procedure: Muscle biopsy; Behavioral: Resistance exercise; Other: Isometric strength test; Dietary 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 Receives: Other: Stable isotope tracer consumption; Radiation: DXA scan; Behavioral: Controlled diet; Other: Saliva sample; Other: Blood sample; Procedure: Muscle biopsy; Behavioral: Resistance exercise; Other: Isometric strength test; Dietary Supplement: Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myofibrillar protein synthesis rates (iMyoPS)
- 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.
Measured: 3 days pre-exercise and 3 days post-exercise
Muscle function
- 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
Measured: pre- and 1, 4, 24, 48 and 72 hr post-exercise
Intramuscular anabolic signalling
- 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
Measured: pre- and 1-hr and 24-hr post-exercise
Muscle morphology
- 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.
Measured: pre- and 1, 24, 48 and 72 hr post-exercise
Secondary outcomes (2)
Muscle soreness
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)
Measured: pre- and 1, 4, 24, 48 and 72 hr post-exercise
Blood markers of muscle damage
Plasma concentrations of systemic markers of muscle damage (creatine kinase, lactate dehydrogenase etc) will be measured from blood samples
Measured: pre- and 1, 4, 24, 48 and 72 hr post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Sep 2023
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle SorenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119749
- Sponsor's protocol ID
- RG_21-198
- Status last verified
- Apr 2025
- First submitted
- 6 May 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rogers LM, Korzepa M, Belfield AE, Quinlan JI, Wallis GA, Breen L. Muscle Recovery and Myofibrillar Protein Synthesis after Damaging Exercise with Recombinant Bovine beta-Lactoglobulin, Dairy-Derived Whey or Carbohydrate Supplementation in Young Healthy Adults. J Nutr. 2026 May;156(5):101321. doi: 10.1016/j.tjnut.2025.101321. Epub 2026 Jan 5.
PubMed 41500363
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ingesting Vegan-friendly Whey Protein on Muscle Anabolism and Recovery Following Damaging Eccentric Resistance Exercise
- ClinicalTrials.gov ID
- NCT07119749
- Acronym / sponsor ID
- RG_21-198
- Conditions
- Muscle Soreness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vegan whey protein | Experimental | Other: Stable isotope tracer consumption, Radiation: DXA scan, Behavioral: Controlled diet, Other: Saliva sample, Other: Blood sample, Procedure: Muscle biopsy, Behavioral: Resistance exercise, Other: Isometric strength test, Dietary Supplement: Supplement3 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 |
| Dairy whey protein | Active comparator | Other: Stable isotope tracer consumption, Radiation: DXA scan, Behavioral: Controlled diet, Other: Saliva sample, Other: Blood sample, Procedure: Muscle biopsy, Behavioral: Resistance exercise, Other: Isometric strength test, Dietary Supplement: Supplement3 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 |
| Carbohydrate placebo | Placebo comparator | Other: Stable isotope tracer consumption, Radiation: DXA scan, Behavioral: Controlled diet, Other: Saliva sample, Other: Blood sample, Procedure: Muscle biopsy, Behavioral: Resistance exercise, Other: Isometric strength test, Dietary Supplement: Supplement3 x daily supplementation of isocaloric carbohydrate placebo for 3 days following an acute bout of lower-body unilateral resistance exercise |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stable isotope tracer consumptionDaily 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 | Other | Carbohydrate placebo, Dairy whey protein, Vegan whey protein |
| DXA scanWhole body DXA scan to assess lean body mass for prescription of deuterium oxide tracer | Radiation | Carbohydrate placebo, Dairy whey protein, Vegan whey protein |
| Controlled dietParticipant 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 | Behavioural | Carbohydrate placebo, Dairy whey protein, Vegan whey protein |
| Saliva sampleObtained from participants by asking them to spit into a tube each day during the study, for 11 days in total. | Other | Carbohydrate placebo, Dairy whey protein, Vegan whey protein |
| Blood sampleResting venous blood sample from a forearm vein on 6 separate occasions | Other | Carbohydrate placebo, Dairy whey protein, Vegan whey protein |
| Muscle biopsyA highly experienced researcher will sample a small section of muscle (~200 mg) from the vastus lateralis muscle under local anaesthetic (5 ml, 1% Lidocaine) | Procedure or surgery | Carbohydrate placebo, Dairy whey protein, Vegan whey protein |
| Resistance exerciseparticipants will complete 8 sets of 10 repetitions of unilateral eccentric knee extensions on an isokinetic dynamometer. | Behavioural | Carbohydrate placebo, Dairy whey protein, Vegan whey protein |
| Isometric strength testBilateral isometric strength will be measured using a well-established protocol on an isokinetic dynamometer. | Other | Carbohydrate placebo, Dairy whey protein, Vegan whey protein |
| SupplementConsumption of 3 supplements a day for 3 days following resistance exercise. All supplements are commercially available. | Dietary supplement | Carbohydrate placebo, Dairy whey protein, Vegan whey protein |
Primary outcome
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.
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
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
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.
2 secondary outcomes
Muscle soreness
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Derived from this study: PubMed 41500363Rogers LM, Korzepa M, Belfield AE, Quinlan JI, Wallis GA, Breen L. Muscle Recovery and Myofibrillar Protein Synthesis after Damaging Exercise with Recombinant Bovine beta-Lactoglobulin, Dairy-Derived Whey or Carbohydrate Supplementation in Young Healthy Adults. J Nutr. 2026 May;156(5):101321. doi: 10.1016/j.tjnut.2025.101321. Epub 2026 Jan 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stable isotope tracer consumption, DXA scan and Saliva sample in people with Muscle Soreness, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myofibrillar protein synthesis rates (iMyoPS) (time frame: 3 days pre-exercise and 3 days post-exercise). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07119749, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.