Vegan Whey Protein for Muscle Anabolism and Post-exercise Recovery

NCT ID: NCT07119749

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-11-22

Brief Summary

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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

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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

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Muscle Soreness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Stable isotope tracer consumption

Intervention Type OTHER

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 scan

Intervention Type RADIATION

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

Controlled diet

Intervention Type BEHAVIORAL

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 sample

Intervention Type OTHER

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

Blood sample

Intervention Type OTHER

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

Muscle biopsy

Intervention Type PROCEDURE

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 exercise

Intervention Type BEHAVIORAL

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

Isometric strength test

Intervention Type OTHER

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

Supplement

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type ACTIVE_COMPARATOR

Stable isotope tracer consumption

Intervention Type OTHER

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 scan

Intervention Type RADIATION

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

Controlled diet

Intervention Type BEHAVIORAL

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 sample

Intervention Type OTHER

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

Blood sample

Intervention Type OTHER

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

Muscle biopsy

Intervention Type PROCEDURE

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 exercise

Intervention Type BEHAVIORAL

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

Isometric strength test

Intervention Type OTHER

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

Supplement

Intervention Type DIETARY_SUPPLEMENT

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

Carbohydrate placebo

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

Group Type PLACEBO_COMPARATOR

Stable isotope tracer consumption

Intervention Type OTHER

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 scan

Intervention Type RADIATION

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

Controlled diet

Intervention Type BEHAVIORAL

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 sample

Intervention Type OTHER

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

Blood sample

Intervention Type OTHER

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

Muscle biopsy

Intervention Type PROCEDURE

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 exercise

Intervention Type BEHAVIORAL

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

Isometric strength test

Intervention Type OTHER

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

Supplement

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type OTHER

DXA scan

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

Intervention Type RADIATION

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

Intervention Type BEHAVIORAL

Saliva sample

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

Intervention Type OTHER

Blood sample

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

Intervention Type OTHER

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)

Intervention Type PROCEDURE

Resistance exercise

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

Intervention Type BEHAVIORAL

Isometric strength test

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

Intervention Type OTHER

Supplement

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Birmingham, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RG_21-198

Identifier Type: -

Identifier Source: org_study_id

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