AgingMASSNCT04325178
Mycoprotein as the Basis of a Sustainable Diet to Support Muscle Mass Maintenance and Reconditioning in Older Adults.
A study of Aging and Sarcopenia, run by University of Exeter at 1 site in United Kingdom.
Trial summary
A hallmark of ageing is loss of skeletal muscle mass and strength (sarcopenia). Sarcopenia is explained, partially, by reduced responsiveness of muscle to dietary protein. This 'anabolic resistance' can be overcome by consuming protein in close proximity to exercise and/or adequate amounts across the day. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Sarcopenia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Mar 2018to 31 Jan 2020
- 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index between 18 and 30
- Recreationally active
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.
- Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥150mmHg over two or more measurements and an average diastolic blood pressure of ≥90mmHg over two or more measurements.)
- Chronic use of statins or diabetic medication.
- A personal or family history of epilepsy, seizures or schizophrenia.
- Allergic to mycoprotein / Quorn, penicillin, or milk.
Trial locations and contacts
1 site in 1 country.
About this study
A hallmark of ageing is loss of skeletal muscle mass and strength (sarcopenia). Sarcopenia is explained, partially, by reduced responsiveness of muscle to dietary protein. This 'anabolic resistance' can be overcome by consuming protein in close proximity to exercise and/or adequate amounts across the day. Consequently, there is momentum for a greater protein RDA for older individuals. Concurrently, there is a need to establish an evidence base for the efficacy of non-animal proteins.
Mycoprotein is a sustainable non-animal derived protein that imposes a significantly lower environmental burden than animal sources. Our previous work suggests that mycoprotein has the potential to support muscle tissue remodelling to a similar extent as animal derived protein sources. The study will employ a deuterium oxide tracer to quantify muscle protein synthesis over a period of three days in response to a vegan diet or animal based diet, alongside daily unilateral resistance exercise in older adults.
Read the detailed description
Dietary protein plays a critical role in the daily regulation of muscle mass by virtue of its ability to regularly stimulate muscle protein synthesis rates. Sarcopenia is mechanistically explained, at least in part, by the reduced responsiveness of older adult's muscle tissue to these anabolic properties of dietary protein. However, this 'anabolic resistance' can be overcome by paying attention to the synergy that exists between the anabolic effects of dietary protein and physical activity. Specifically, consuming dietary protein in close temporal proximity to physical activity and/or adequate amounts of dietary protein per meal is an effective strategy to optimise muscle protein metabolism in older adults. These mechanistic, physiological findings are supported by longitudinal studies showing that older individuals who consume modestly greater amounts of dietary protein than the current RDA, and/or maintain/adopt an active lifestyle, experience reduced rates of sarcopenia and typically live healthier lives.
With the importance of dietary protein to support active, healthy ageing evident, and a consequent scientific momentum moving towards a considerable (≥50%) rise in recommended protein intake for older individuals, the inevitable question arises: 'where should this dietary protein to support healthy ageing come from?' Current and future generations are required to view developments in human nutrition through the lens of mounting challenges associated with the sustainability of increased production of animal proteins, a concern also of primary importance to Quorn Foods. However, research into the nutritional physiology of alternative, sustainable, non-animal derived protein sources is in its infancy, particularly so in older adults. Therefore, there is considerable scientific interest, public health value and commercial opportunity in establishing a robust evidence base for the efficacy of non-animal, sustainably produced dietary protein sources to support active, healthy ageing.
Mycoprotein, a food source produced by continuous fermentation of the filamentous fungus Fusarium venenatum, imposes a significantly lower environmental burden during its production compared with animal sources. In collaboration with Quorn Foods, we recently reported that acute consumption of mycoprotein in young adults results in equivalent amino acid bioavailability to that of milk protein, and therefore shows promise as a protein source to support muscle anabolism and metabolic health in numerous populations. In the present proposal, we wish to translate and extend these findings into the older adult population. We will exploit a stable isotope tracer approach (oral administration of deuterium oxide ['heavy water']) to make in vivo measurements of cumulative, free living muscle protein synthesis rates in response to a highly sustainable, non-animal derived, mycoprotein based diet with or without physical activity, compared with a more traditional diet reliant on animal derived protein sources (matched for total protein). The study will increase our knowledge of how effective non-animal derived proteins are at supporting muscle tissue remodelling in the elderly.
- Conditions
- Aging, Sarcopenia
- Being tested
- Protein, calorie and macronutrient controlled diet, derived from either omnivorous or non-animal sources, alongside unilateral resistance exercise, over a three-day period.
- Keywords
- Ageing, Muscle protein synthesis, Resistance exercise, Sarcopenia, Sustainable protein
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein, calorie and macronutrient controlled diet, derived from either omnivorous or non-animal sources, alongside unilateral resistance exercise, over a three-day period.Other
Participants received a control diet either derived from omnivorous or non-animal food sources, providing 1.8g.kg.day of protein, for a three-day period. Calories were calculated and set to place participants in a state of energy balance. Participants completed three bouts of unilateral resistance exercise, 5 sets of 30 maximal concentric knee extension contractions, on each morning that they received the control diet. During this three-day period participants also consumed a deuterium oxide tracer allowing for the measurement of muscle protein synthesis, in rested and exercised tissue, with incremental biopsies.
| Study group | Role | What they receive |
|---|---|---|
| Animal | Experimental | Participants receive the majority of their protein from animal-derived protein sources (1.8g.kg.day). Receives: Other: Protein, calorie and macronutrient controlled diet, derived from either omnivorous or non-animal sources, alongside unilateral resistance exercise, over a three-day period. |
| Non-animal | Experimental | Participants receive all their protein from non-animal-derived protein sources (1.8g.kg.day). Receives: Other: Protein, calorie and macronutrient controlled diet, derived from either omnivorous or non-animal sources, alongside unilateral resistance exercise, over a three-day period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis
Calculation of muscle protein synthesis using the product-precursor method, with deuterium in the body water pool utilised as the precursor and the incorporation of deuterated alanine into muscle tissue as the product.
Measured: Three days.
Secondary outcomes (1)
Resistance-type exercise work done
The work done (J) over 5 sets of 30 isokinetic knee extension contractions, on three consecutive days.
Measured: Three days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start22 Mar 2018
- Primary completion13 Sep 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325178
- Sponsor's protocol ID
- uexeter
- Acronym
- MASS
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- 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 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycoprotein as the Basis of a Sustainable Diet to Support Muscle Mass Maintenance and Reconditioning in Older Adults.
- ClinicalTrials.gov ID
- NCT04325178
- Acronym / sponsor ID
- MASS / uexeter
- Conditions
- Aging, Sarcopenia
- Keywords
- Ageing, Muscle protein synthesis, Resistance exercise, Sarcopenia, Sustainable protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 13 Sep 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 27 Mar 2020 (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.
A hallmark of ageing is loss of skeletal muscle mass and strength (sarcopenia). Sarcopenia is explained, partially, by reduced responsiveness of muscle to dietary protein. This 'anabolic resistance' can be overcome by consuming protein in close proximity to exercise and/or adequate amounts across the day. Consequently, there is momentum for a greater protein RDA for older individuals. Concurrently, there is a need to establish an evidence base for the efficacy of non-animal proteins.
Mycoprotein is a sustainable non-animal derived protein that imposes a significantly lower environmental burden than animal sources. Our previous work suggests that mycoprotein has the potential to support muscle tissue remodelling to a similar extent as animal derived protein sources. The study will employ a deuterium oxide tracer to quantify muscle protein synthesis over a period of three days in response to a vegan diet or animal based diet, alongside daily unilateral resistance exercise in older adults.
Detailed description
Dietary protein plays a critical role in the daily regulation of muscle mass by virtue of its ability to regularly stimulate muscle protein synthesis rates. Sarcopenia is mechanistically explained, at least in part, by the reduced responsiveness of older adult's muscle tissue to these anabolic properties of dietary protein. However, this 'anabolic resistance' can be overcome by paying attention to the synergy that exists between the anabolic effects of dietary protein and physical activity. Specifically, consuming dietary protein in close temporal proximity to physical activity and/or adequate amounts of dietary protein per meal is an effective strategy to optimise muscle protein metabolism in older adults. These mechanistic, physiological findings are supported by longitudinal studies showing that older individuals who consume modestly greater amounts of dietary protein than the current RDA, and/or maintain/adopt an active lifestyle, experience reduced rates of sarcopenia and typically live healthier lives.
With the importance of dietary protein to support active, healthy ageing evident, and a consequent scientific momentum moving towards a considerable (≥50%) rise in recommended protein intake for older individuals, the inevitable question arises: 'where should this dietary protein to support healthy ageing come from?' Current and future generations are required to view developments in human nutrition through the lens of mounting challenges associated with the sustainability of increased production of animal proteins, a concern also of primary importance to Quorn Foods. However, research into the nutritional physiology of alternative, sustainable, non-animal derived protein sources is in its infancy, particularly so in older adults. Therefore, there is considerable scientific interest, public health value and commercial opportunity in establishing a robust evidence base for the efficacy of non-animal, sustainably produced dietary protein sources to support active, healthy ageing.
Mycoprotein, a food source produced by continuous fermentation of the filamentous fungus Fusarium venenatum, imposes a significantly lower environmental burden during its production compared with animal sources. In collaboration with Quorn Foods, we recently reported that acute consumption of mycoprotein in young adults results in equivalent amino acid bioavailability to that of milk protein, and therefore shows promise as a protein source to support muscle anabolism and metabolic health in numerous populations. In the present proposal, we wish to translate and extend these findings into the older adult population. We will exploit a stable isotope tracer approach (oral administration of deuterium oxide ['heavy water']) to make in vivo measurements of cumulative, free living muscle protein synthesis rates in response to a highly sustainable, non-animal derived, mycoprotein based diet with or without physical activity, compared with a more traditional diet reliant on animal derived protein sources (matched for total protein). The study will increase our knowledge of how effective non-animal derived proteins are at supporting muscle tissue remodelling in the elderly.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Animal | Experimental | Other: Protein, calorie and macronutrient controlled diet, derived from either omnivorous or non-animal sources, alongside unilateral resistance exercise, over a three-day period.Participants receive the majority of their protein from animal-derived protein sources (1.8g.kg.day). |
| Non-animal | Experimental | Other: Protein, calorie and macronutrient controlled diet, derived from either omnivorous or non-animal sources, alongside unilateral resistance exercise, over a three-day period.Participants receive all their protein from non-animal-derived protein sources (1.8g.kg.day). |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index between 18 and 30
- Recreationally active
Key exclusion criteria (6 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.
- Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥150mmHg over two or more measurements and an average diastolic blood pressure of ≥90mmHg over two or more measurements.)
- Chronic use of statins or diabetic medication.
- 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 |
|---|---|---|
| Protein, calorie and macronutrient controlled diet, derived from either omnivorous or non-animal sources, alongside unilateral resistance exercise, over a three-day period.Participants received a control diet either derived from omnivorous or non-animal food sources, providing 1.8g.kg.day of protein, for a three-day period. Calories were calculated and set to place participants in a state of energy balance. Participants completed three bouts of unilateral resistance exercise, 5 sets of 30 maximal concentric knee extension contractions, on each morning that they received the control diet. During this three-day period participants also consumed a deuterium oxide tracer allowing for the measurement of muscle protein synthesis, in rested and exercised tissue, with incremental biopsies. | Other | Animal, Non-animal |
Primary outcome
Muscle protein synthesis
Time frame: Three days.
Calculation of muscle protein synthesis using the product-precursor method, with deuterium in the body water pool utilised as the precursor and the incorporation of deuterated alanine into muscle tissue as the product.
1 secondary outcome
Resistance-type exercise work done
Time frame: Three days.
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 Mar 2020.
- 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 of Aging and Sarcopenia, 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 6 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 Mar 2020. 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: Three 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 27 Mar 2020.