Healthy AgingMVPNCT05985369
Vegan and Omnivorous Diets and Skeletal Muscle Turnover in Healthy Older Adults
A study of Healthy Aging, run by University of Exeter at 1 site in United Kingdom.
Trial summary
Dietary protein intake and physical activity are key to minimise the age-related loss of skeletal muscle mass. While animal-derived protein sources are considered high-quality anabolic foods, it remains unclear whether non-animal-derived (vegan) protein sources support skeletal muscle maintenance and healthy ageing. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Nov 2022to 31 Oct 2023
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 18.5 - 30
- Active (not very sedentary and not master athlete; assessed via IPAQ)
- Women only: post menopause
Who cannot join
- Hypertension (>150/90 mmHg)
- Any diagnosed metabolic impairment
- Any diagnosed cardiovascular disease
- Any diagnosed gastrointestinal disease
- Diagnosed cancer
- Any medication known to affect muscle metabolism (e.g. hormone replacement therapy)
- Severe food allergies or intolerances (e.g. celiac, lactose intolerance, allergic to fungi or algae foods)
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a High-quality Vegan Diet on Skeletal Muscle Maintenance and Adaptation in Comparison to a Protein-matched Omnivorous Diet in Healthy Older Adults.
Dietary protein intake and physical activity are key to minimise the age-related loss of skeletal muscle mass. While animal-derived protein sources are considered high-quality anabolic foods, it remains unclear whether non-animal-derived (vegan) protein sources support skeletal muscle maintenance and healthy ageing. The aim of the present study is to assess the effect of a vegan diet on daily muscle protein synthesis rates compared to a protein-matched omnivorous diet where the majority of protein is derived from high-quality animal-based protein sources.
Read the detailed description
Background: The age-related loss of muscle mass and strength is (partly) explained by a blunted responsiveness of skeletal muscle to the anabolic properties of dietary protein and muscle contraction. Therefore, sufficient dietary protein intake and physical activity are required to minimise age-related muscle atrophy. It remains unknown whether this can be achieved utilising non-animal-derived (vegan) protein sources.
Objective: To assess daily muscle protein synthesis rates when adopting a vegan or protein-matched omnivorous control diet.
Methods: Healthy older adults (aged 60-80 years) will be randomly allocated to a completely controlled 1-week vegan (providing 0.8 g/kg BW/day protein) or protein-matched omnivorous diet. During this week, participants will perform a set of unilateral leg resistance exercise on day 1, 3, and 5. Deuterium oxide in combination with saliva and muscle sample (from the m. vastus lateralis) collection will be used to measure daily muscle protein synthesis rates in resting and exercised tissue.
Value: This will be the first study assessing daily muscle protein turnover in healthy older adults adopting a 1-week vegan diet. This will contribute to the understanding and viability of vegan protein to support active and healthy ageing.
- Conditions
- Healthy Aging
- Being tested
- Controlled diet and resistance exercise
- Keywords
- Muscle metabolism, Protein metabolism, Sarcopenia, Resistance exercise
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled diet and resistance exerciseOther
Participants will adopt a 1-week completely controlled diet and perform 3 sessions of unilateral leg resistance exercise.
| Study group | Role | What they receive |
|---|---|---|
| Vegan diet | Experimental | Participants will be allocated to a fully controlled 1-week vegan diet containing 0.8 g/kg BW/day of protein where all protein provided will be derived from non-animal-derived protein sources. Receives: Other: Controlled diet and resistance exercise |
| Omnivorous diet | Experimental | Participants will be allocated to a fully controlled 1-week omnivorous diet containing 0.8 g/kg BW/day of protein where the majority of protein will be derived from animal-derived protein sources. Receives: Other: Controlled diet and resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis (MPS) in resting and exercised tissue
Daily MPS rates, expressed as fractional synthetic rate (%/h)
Measured: 7 days
Secondary outcomes (1)
Muscle morphology
Changes in muscle thickness during the intervention period, measured via ultrasound
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start9 Nov 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- 22 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
- NCT05985369
- Sponsor's protocol ID
- 524790
- Acronym
- MVP
- Status last verified
- Apr 2024
- First submitted
- 2 Aug 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a High-quality Vegan Diet on Skeletal Muscle Maintenance and Adaptation in Comparison to a Protein-matched Omnivorous Diet in Healthy Older Adults.
- ClinicalTrials.gov ID
- NCT05985369
- Acronym / sponsor ID
- MVP / 524790
- Conditions
- Healthy Aging
- Keywords
- Muscle metabolism, Protein metabolism, Sarcopenia, Resistance exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 14 Aug 2023 (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.
Dietary protein intake and physical activity are key to minimise the age-related loss of skeletal muscle mass. While animal-derived protein sources are considered high-quality anabolic foods, it remains unclear whether non-animal-derived (vegan) protein sources support skeletal muscle maintenance and healthy ageing. The aim of the present study is to assess the effect of a vegan diet on daily muscle protein synthesis rates compared to a protein-matched omnivorous diet where the majority of protein is derived from high-quality animal-based protein sources.
Detailed description
Background: The age-related loss of muscle mass and strength is (partly) explained by a blunted responsiveness of skeletal muscle to the anabolic properties of dietary protein and muscle contraction. Therefore, sufficient dietary protein intake and physical activity are required to minimise age-related muscle atrophy. It remains unknown whether this can be achieved utilising non-animal-derived (vegan) protein sources.
Objective: To assess daily muscle protein synthesis rates when adopting a vegan or protein-matched omnivorous control diet.
Methods: Healthy older adults (aged 60-80 years) will be randomly allocated to a completely controlled 1-week vegan (providing 0.8 g/kg BW/day protein) or protein-matched omnivorous diet. During this week, participants will perform a set of unilateral leg resistance exercise on day 1, 3, and 5. Deuterium oxide in combination with saliva and muscle sample (from the m. vastus lateralis) collection will be used to measure daily muscle protein synthesis rates in resting and exercised tissue.
Value: This will be the first study assessing daily muscle protein turnover in healthy older adults adopting a 1-week vegan diet. This will contribute to the understanding and viability of vegan protein to support active and healthy ageing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegan diet | Experimental | Other: Controlled diet and resistance exerciseParticipants will be allocated to a fully controlled 1-week vegan diet containing 0.8 g/kg BW/day of protein where all protein provided will be derived from non-animal-derived protein sources. |
| Omnivorous diet | Experimental | Other: Controlled diet and resistance exerciseParticipants will be allocated to a fully controlled 1-week omnivorous diet containing 0.8 g/kg BW/day of protein where the majority of protein will be derived from animal-derived protein sources. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI between 18.5 - 30
- Active (not very sedentary and not master athlete; assessed via IPAQ)
- Women only: post menopause
Key exclusion criteria (8 listed)
- Hypertension (>150/90 mmHg)
- Any diagnosed metabolic impairment
- Any diagnosed cardiovascular disease
- Any diagnosed gastrointestinal disease
- Diagnosed cancer
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 |
|---|---|---|
| Controlled diet and resistance exerciseParticipants will adopt a 1-week completely controlled diet and perform 3 sessions of unilateral leg resistance exercise. | Other | Omnivorous diet, Vegan diet |
Primary outcome
Muscle protein synthesis (MPS) in resting and exercised tissue
Time frame: 7 days
Daily MPS rates, expressed as fractional synthetic rate (%/h)
1 secondary outcome
Muscle morphology
Time frame: 7 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 24 Apr 2024.
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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 Healthy Aging, 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 3 inclusion and 8 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 24 Apr 2024. 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 (MPS) in resting and exercised tissue (time frame: 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 24 Apr 2024.