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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United Kingdom1 site
  • University of Exeter

    Exeter, Devon, EX1 2LU

Other trials in United Kingdom

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 groups in NCT04325178
Study groupRoleWhat they receive
AnimalExperimentalParticipants 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-animalExperimentalParticipants 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.

  1. 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)
  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.

  1. First posted27 Mar 2020
  2. Study start22 Mar 2018
  3. Primary completion13 Sep 2019
  4. Study completion31 Jan 2020

Resources

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)
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

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.

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