Muscle RecoveryVAMPIRENCT04156386
Vegan or Animal Protein Ingestion on the Recovery of Muscle Function Following Exercise
A study testing Recovery animal (20g whey) protein supplement and Recover vegan (26g pea) protein supplement in people with Muscle Recovery, run by University of Exeter at 1 site in United Kingdom.
Trial summary
This study will assess the effect of daily post-exercise vegan (pea) and animal (whey) protein ingestion compared to placebo over 7 days of recovery from strenuous exercise. Muscle strength and soreness will be measured daily, and mechanisms underpinning recovery will be investigated in muscle biopsies taken 3, 24 and… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Recovery
- What is being tested?
- Recovery animal (20g whey) protein supplement and Recover vegan (26g pea) protein supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Sep 2019to 23 Apr 2022
- 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
- Recreationally active
- 18-40 years of age
Who cannot join
- Regular and structured involvement in resistance training
- Inactive participants
- Habitual dietary protein intake <0.8g/kg bw/day and >2.0g/kg bw/day
- Use of nutritional supplements
- Any diagnosed metabolic conditions (diabetes), cardiovascular disease or hypertension
- Current musculoskeletal injury
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- Use of anti-inflammatory medicines
- Individuals with non -removable metallic implants (including heart pacemaker, cochlea implants, medication pumps, surgical clips, plates or screws) or claustrophobia
- Individuals with an allergy to egg, fish, wheat or soy ingredients as the product is manufactured in a facility that contains these ingredients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vegan or Animal Protein Ingestion on the Recovery of Skeletal Muscle Function Following Strenuous Exercise
This study will assess the effect of daily post-exercise vegan (pea) and animal (whey) protein ingestion compared to placebo over 7 days of recovery from strenuous exercise. Muscle strength and soreness will be measured daily, and mechanisms underpinning recovery will be investigated in muscle biopsies taken 3, 24 and 48 hours after exercise.
Read the detailed description
Strenuous exercise can cause muscle soreness and reduced muscle strength. It is widely acknowledged that nutritional supplements derived from animal protein sources, including whey from milk, aids recovery when taken immediately after strenuous exercise. However, the effect of vegan protein supplements are less understood, and how they affect recovery of strength and soreness is not known. This is an important area of research due to the increasing demand for plant-based protein.
- Conditions
- Muscle Recovery
- Being tested
- Recovery animal (20g whey) protein supplement, Recover vegan (26g pea) protein supplement, Placebo (32g maltodextrin)
- Keywords
- Muscle Strength, Musculoskeletal Physiology, Muscle, Skeletal, Whey Proteins, Plant Proteins, Dietary supplements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery animal (20g whey) protein supplementDietary supplement
Animal protein supplement consumed post exercise to aid recovery of muscle function following strenuous exercise.
Recover vegan (26g pea) protein supplementDietary supplement
Vegan protein supplement consumed post exercise to aid recovery of muscle function following strenuous exercise.
Placebo (32g maltodextrin)Dietary supplement
Placebo consumed post exercise to aid recovery of muscle function following strenuous exercise.
| Study group | Role | What they receive |
|---|---|---|
| Animal Protein | Active comparator | Not described Receives: Dietary Supplement: Recovery animal (20g whey) protein supplement |
| Vegan Protein | Active comparator | Not described Receives: Dietary Supplement: Recover vegan (26g pea) protein supplement |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo (32g maltodextrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in isokinetic work (W30) performed before and every 24 h after performing 300 maximal eccentric quadriceps contractions.
The recovery of skeletal muscle isokinetic force production following eccentric exercise using an isokinetic dynamometer
Measured: Once per 24 hour period for 7 days
Secondary outcomes (5)
Perceived quadriceps muscle soreness
Soreness will be assessed using a visual analogue scale (VAS) to determine whether the protein supplement can reduce muscle soreness following eccentric exercise. This scale will represent a 100mm line with no pain and worst pain anchored at either end of the scale.
Measured: Once per 24 hour period for 7 days
Muscle swelling
Determine whether the protein supplement can reduce muscle swelling following eccentric exercise assessed using MRI
Measured: Once per 24 hour period for 3 days
Rate of protein incorporation into the muscle
Determine whether the strenuous exercise and a protein supplement can upregulate protein synthesis following strenuous exercise assessed by muscle biopsies
Measured: Once per 24 hour period for 3 days
Plasma creatine kinase (CK) activity before and every 24 h after performing 300 maximal eccentric quadriceps contractions.
Damage and inflammatory bio markers following strenuous exercise assessed by blood sample
Measured: Once per 24 hour period for 7 days
Change in flow mediated dilation
Determine whether the protein polyphenol supplement can impact vascular function following eccentric exercise
Measured: Once hourly post exercise for 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start23 Sep 2019
- Primary completion23 Apr 2022
- Study completion23 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle RecoveryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Beachbody
- Responsible party
- Sponsor
- Investigators
- Francis Stephens, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156386
- Sponsor's protocol ID
- 190703-B-01
- Acronym
- VAMPIRE
- Status last verified
- Mar 2023
- First submitted
- 6 Sep 2019
- Last updated
- 22 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vegan or Animal Protein Ingestion on the Recovery of Skeletal Muscle Function Following Strenuous Exercise
- ClinicalTrials.gov ID
- NCT04156386
- Acronym / sponsor ID
- VAMPIRE / 190703-B-01
- Conditions
- Muscle Recovery
- Keywords
- Muscle Strength, Musculoskeletal Physiology, Muscle, Skeletal, Whey Proteins, Plant Proteins, Dietary supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Beachbody
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 23 Apr 2022 (actual)
- Study completion
- 23 Apr 2022 (actual)
- First posted
- 7 Nov 2019 (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 assess the effect of daily post-exercise vegan (pea) and animal (whey) protein ingestion compared to placebo over 7 days of recovery from strenuous exercise. Muscle strength and soreness will be measured daily, and mechanisms underpinning recovery will be investigated in muscle biopsies taken 3, 24 and 48 hours after exercise.
Detailed description
Strenuous exercise can cause muscle soreness and reduced muscle strength. It is widely acknowledged that nutritional supplements derived from animal protein sources, including whey from milk, aids recovery when taken immediately after strenuous exercise. However, the effect of vegan protein supplements are less understood, and how they affect recovery of strength and soreness is not known. This is an important area of research due to the increasing demand for plant-based protein.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Animal Protein | Active comparator | Dietary Supplement: Recovery animal (20g whey) protein supplement |
| Vegan Protein | Active comparator | Dietary Supplement: Recover vegan (26g pea) protein supplement |
| Placebo | Placebo comparator | Dietary Supplement: Placebo (32g maltodextrin) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Recreationally active
- 18-40 years of age
Key exclusion criteria (9 listed)
- Regular and structured involvement in resistance training
- Inactive participants
- Habitual dietary protein intake <0.8g/kg bw/day and >2.0g/kg bw/day
- Use of nutritional supplements
- Any diagnosed metabolic conditions (diabetes), cardiovascular disease or hypertension
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 |
|---|---|---|
| Recovery animal (20g whey) protein supplementAnimal protein supplement consumed post exercise to aid recovery of muscle function following strenuous exercise. | Dietary supplement | Animal Protein |
| Recover vegan (26g pea) protein supplementVegan protein supplement consumed post exercise to aid recovery of muscle function following strenuous exercise. | Dietary supplement | Vegan Protein |
| Placebo (32g maltodextrin)Placebo consumed post exercise to aid recovery of muscle function following strenuous exercise. | Dietary supplement | Placebo |
Primary outcome
Change in isokinetic work (W30) performed before and every 24 h after performing 300 maximal eccentric quadriceps contractions.
Time frame: Once per 24 hour period for 7 days
The recovery of skeletal muscle isokinetic force production following eccentric exercise using an isokinetic dynamometer
5 secondary outcomes
Perceived quadriceps muscle soreness
Time frame: Once per 24 hour period for 7 days
Muscle swelling
Time frame: Once per 24 hour period for 3 days
Rate of protein incorporation into the muscle
Time frame: Once per 24 hour period for 3 days
Plasma creatine kinase (CK) activity before and every 24 h after performing 300 maximal eccentric quadriceps contractions.
Time frame: Once per 24 hour period for 7 days
Change in flow mediated dilation
Time frame: Once hourly post exercise for 3 hours
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 22 Mar 2023.
- 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.
Francis Stephens principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery animal (20g whey) protein supplement and Recover vegan (26g pea) protein supplement in people with Muscle Recovery, run by University of Exeter 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 2 inclusion and 9 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 22 Mar 2023. 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?
Change in isokinetic work (W30) performed before and every 24 h after performing 300 maximal eccentric quadriceps contractions. (time frame: Once per 24 hour period for 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2023.