- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04156386
Vegan or Animal Protein Ingestion on the Recovery of Muscle Function Following Exercise (VAMPIRE)
March 21, 2023 updated by: University of Exeter
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
30
Phase
- 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 Contact
- Name: Kiera Wilkinson
- Phone Number: 07905299691
- Email: kw509@exeter.ac.uk
Study Contact Backup
- Name: Amy Booth
- Email: ab1201@exeter.ac.uk
Study Locations
-
-
-
Exeter, United Kingdom, EX1 1TX
- University of Exeter
-
-
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
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Recreationally active
- 18-40 years of age
Exclusion Criteria:
- 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
- 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
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo consumed post exercise to aid recovery of muscle function following strenuous exercise.
|
Active Comparator: Vegan Protein
|
Vegan protein supplement consumed post exercise to aid recovery of muscle function following strenuous exercise.
|
Active Comparator: Animal Protein
|
Animal protein supplement consumed post exercise to aid recovery of muscle function following strenuous exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Once per 24 hour period for 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived quadriceps muscle soreness
Time Frame: Once per 24 hour period for 7 days
|
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.
|
Once per 24 hour period for 7 days
|
Muscle swelling
Time Frame: Once per 24 hour period for 3 days
|
Determine whether the protein supplement can reduce muscle swelling following eccentric exercise assessed using MRI
|
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
|
Determine whether the strenuous exercise and a protein supplement can upregulate protein synthesis following strenuous exercise assessed by muscle biopsies
|
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
|
Damage and inflammatory bio markers following strenuous exercise assessed by blood sample
|
Once per 24 hour period for 7 days
|
Change in flow mediated dilation
Time Frame: Once hourly post exercise for 3 hours
|
Determine whether the protein polyphenol supplement can impact vascular function following eccentric exercise
|
Once hourly post exercise for 3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
September 23, 2019
Primary Completion (Actual)
April 23, 2022
Study Completion (Actual)
April 23, 2022
Study Registration Dates
First Submitted
September 6, 2019
First Submitted That Met QC Criteria
November 6, 2019
First Posted (Actual)
November 7, 2019
Study Record Updates
Last Update Posted (Actual)
March 22, 2023
Last Update Submitted That Met QC Criteria
March 21, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 190703-B-01
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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