HypertrophyHAMNCT03572127
Mycoprotein, Resistance Training, and Hypertrophy
A study testing Diet in people with Hypertrophy, run by University of Exeter at 1 site in United Kingdom.
Trial summary
Protein is vital for the preservation of health and optimal adaptation to training. However, animal proteins come with economic and environmental issues. The study will investigate the effect of non-animal vs animal based habitual protein consumption on muscle protein metabolism and changes in muscle mass and function… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertrophy
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 May 2018to 1 May 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
- Males and females 18 - 40 years of age.
- Body mass index between 18 and 30.
- Recreationally active.
- Resistance training experienced (have previous performed resistance exercise, and are familiar with the basic movements).
Who cannot join
- Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes) (as this may affect normal protein metabolism).
- Any diagnosed cardiovascular disease or hypertension (to avoid any complications associated with heavy exercise).
- Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥140mmHg over two or more measurements and an average diastolic blood pressure of ≥90mmHg over two or more measurements.)
- Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism).
- A personal or family history of epilepsy, seizures or schizophrenia.
- Allergic to mycoprotein / Quorn, penicillin, or milk.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Exeter, Sports & Health Sciences, College of Life & Environmental Sciences
Exeter, Devon, EX1 2LU
About this study
Official title: Does Obtaining the Majority of Dietary Protein From Non-animal Sources Support the Skeletal Muscle Adaptive Response to Structured Resistance Training in Young Men and Women
Protein is vital for the preservation of health and optimal adaptation to training. However, animal proteins come with economic and environmental issues. The study will investigate the effect of non-animal vs animal based habitual protein consumption on muscle protein metabolism and changes in muscle mass and function over a longer period of time.
Read the detailed description
Protein is vital for the preservation of health and optimal adaptation to training. However, animal proteins come with a number of economic and environmental issues. Accordingly, the investigators need to develop an evidence base for more sustainable dietary proteins to support human nutrition. Mycoprotein is a non-animal protein produced by the continuous fermentation of the fungus Fusarium Venenatum. Previously, in a mechanistic study, it was determined that a single bolus of mycoprotein effectively supports muscle building in both rested and exercised skeletal muscle, to a similar extent as what would be expected of animal proteins. This suggests that similar adaptation of muscle tissue during training could be achieved when protein is obtained from non-animal derived protein sources.
The study will investigate the effect of high non-animal vs animal based habitual protein consumption on muscle protein metabolism and changes in muscle mass and function over a longer period of time. Initially, the study will employ a stable isotope tracer to quantify muscle protein synthesis over a period of three days in healthy male and female volunteers. During this time participants will consume a controlled vegan diet or an animal based diet, with daily unilateral resistance exercise. The second phase of the study will employ a 10 week diet and resistance training intervention, with the majority of a participant's protein either coming from animal or non-animal sources. This will determine the ability of a largely non-animal derived diet to support augmentations in muscle size and strength.
Briefly, participants will undergo 6 muscle biopsies over the course of an 11 week period. Initial biopsies will quantify muscle protein synthesis. Subsequent biopsies will characterise the adaptive response to the effects of nutrition and exercise. MRI scans will be employed to determine changes in muscle volume, and DXA scans will measure changes in body composition.
- Conditions
- Hypertrophy
- Being tested
- Diet
- Keywords
- Protein, Resistance Exercise, Skeletal Muscle, Mycoprotein, Sustainability
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
High protein diet derived from either animal or non-animal sources.
| Study group | Role | What they receive |
|---|---|---|
| Non-animal derived diet | Experimental | High protein diet derived from non-animal sources. Receives: Other: Diet |
| Animal derived diet | Active comparator | High protein diet derived from animal sources. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Protein Synthesis
Muscle protein synthesis measured via deuterium oxide
Measured: 3 days
Secondary outcomes (3)
Muscle fiber CSA
Changes in muscle fiber CSA
Measured: 10 weeks
Muscle Strength
Changes in muscle strength
Measured: 10 weeks
Muscle CSA
Changes in muscle CSA as measured by MRI
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start16 May 2018
- Primary completion1 Mar 2020
- Study completion1 May 2022
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 HypertrophyStudies 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
- Model description
- One group will consume a non-animal derived high protein diet, whilst the other group will consume a more traditional animal protein based diet.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Quorn
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572127
- Sponsor's protocol ID
- 1718/27
- Acronym
- HAM
- Status last verified
- Apr 2025
- First submitted
- 21 May 2018
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Monteyne AJ, Coelho MOC, Murton AJ, Abdelrahman DR, Blackwell JR, Koscien CP, Knapp KM, Fulford J, Finnigan TJA, Dirks ML, Stephens FB, Wall BT. Vegan and Omnivorous High Protein Diets Support Comparable Daily Myofibrillar Protein Synthesis Rates and Skeletal Muscle Hypertrophy in Young Adults. J Nutr. 2023 Jun;153(6):1680-1695. doi: 10.1016/j.tjnut.2023.02.023. Epub 2023 Feb 22.
PubMed 36822394
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Obtaining the Majority of Dietary Protein From Non-animal Sources Support the Skeletal Muscle Adaptive Response to Structured Resistance Training in Young Men and Women
- ClinicalTrials.gov ID
- NCT03572127
- Acronym / sponsor ID
- HAM / 1718/27
- Conditions
- Hypertrophy
- Keywords
- Protein, Resistance Exercise, Skeletal Muscle, Mycoprotein, Sustainability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Quorn
- Study start
- 16 May 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 28 Jun 2018 (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.
Protein is vital for the preservation of health and optimal adaptation to training. However, animal proteins come with economic and environmental issues. The study will investigate the effect of non-animal vs animal based habitual protein consumption on muscle protein metabolism and changes in muscle mass and function over a longer period of time.
Detailed description
Protein is vital for the preservation of health and optimal adaptation to training. However, animal proteins come with a number of economic and environmental issues. Accordingly, the investigators need to develop an evidence base for more sustainable dietary proteins to support human nutrition. Mycoprotein is a non-animal protein produced by the continuous fermentation of the fungus Fusarium Venenatum. Previously, in a mechanistic study, it was determined that a single bolus of mycoprotein effectively supports muscle building in both rested and exercised skeletal muscle, to a similar extent as what would be expected of animal proteins. This suggests that similar adaptation of muscle tissue during training could be achieved when protein is obtained from non-animal derived protein sources.
The study will investigate the effect of high non-animal vs animal based habitual protein consumption on muscle protein metabolism and changes in muscle mass and function over a longer period of time. Initially, the study will employ a stable isotope tracer to quantify muscle protein synthesis over a period of three days in healthy male and female volunteers. During this time participants will consume a controlled vegan diet or an animal based diet, with daily unilateral resistance exercise. The second phase of the study will employ a 10 week diet and resistance training intervention, with the majority of a participant's protein either coming from animal or non-animal sources. This will determine the ability of a largely non-animal derived diet to support augmentations in muscle size and strength.
Briefly, participants will undergo 6 muscle biopsies over the course of an 11 week period. Initial biopsies will quantify muscle protein synthesis. Subsequent biopsies will characterise the adaptive response to the effects of nutrition and exercise. MRI scans will be employed to determine changes in muscle volume, and DXA scans will measure changes in body composition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group will consume a non-animal derived high protein diet, whilst the other group will consume a more traditional animal protein based diet.
| Arm | Type | Receives |
|---|---|---|
| Non-animal derived diet | Experimental | Other: DietHigh protein diet derived from non-animal sources. |
| Animal derived diet | Active comparator | Other: DietHigh protein diet derived from animal sources. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females 18 - 40 years of age.
- Body mass index between 18 and 30.
- Recreationally active.
- Resistance training experienced (have previous performed resistance exercise, and are familiar with the basic movements).
Key exclusion criteria (7 listed)
- Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes) (as this may affect normal protein metabolism).
- Any diagnosed cardiovascular disease or hypertension (to avoid any complications associated with heavy exercise).
- Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥140mmHg over two or more measurements and an average diastolic blood pressure of ≥90mmHg over two or more measurements.)
- Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism).
- A personal or family history of epilepsy, seizures or schizophrenia.
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 |
|---|---|---|
| DietHigh protein diet derived from either animal or non-animal sources. | Other | Animal derived diet, Non-animal derived diet |
Primary outcome
Muscle Protein Synthesis
Time frame: 3 days
Muscle protein synthesis measured via deuterium oxide
3 secondary outcomes
Muscle fiber CSA
Time frame: 10 weeks
Muscle Strength
Time frame: 10 weeks
Muscle CSA
Time frame: 10 weeks
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 27 Apr 2025.
- Derived from this study: PubMed 36822394Monteyne AJ, Coelho MOC, Murton AJ, Abdelrahman DR, Blackwell JR, Koscien CP, Knapp KM, Fulford J, Finnigan TJA, Dirks ML, Stephens FB, Wall BT. Vegan and Omnivorous High Protein Diets Support Comparable Daily Myofibrillar Protein Synthesis Rates and Skeletal Muscle Hypertrophy in Young Adults. J Nutr. 2023 Jun;153(6):1680-1695. doi: 10.1016/j.tjnut.2023.02.023. Epub 2023 Feb 22.
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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 Diet in people with Hypertrophy, 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 4 inclusion and 7 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 27 Apr 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. 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?
Muscle Protein Synthesis (time frame: 3 days). 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 NCT03572127, 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 27 Apr 2025.