Healthy AgingNOVANCT04297137
The Bioavailability of Multiple Novel, Sustainable, Non-animal Derived Protein Sources
A study testing Protein ingestion in people with Healthy Aging, run by University of Exeter at 1 site in United Kingdom.
Trial summary
The progressive age-related loss of muscle mass is termed sarcopenia. Consequences of sarcopenia are, but not limited to, decreased muscle strength, frailty, and an increased risk for the development of chronic metabolic diseases. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Protein ingestion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Nov 2019to 1 Oct 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females aged 18-35 or 55 - 80 years old.
- Body mass index between 18.5 - 30.
Who cannot join
- Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes).
- Any diagnosed cardiovascular disease or hypertension.
- Elevated blood pressure (>150/90 mmHg) at the time of screening.
- Known pre-existing liver disease/condition.
- Any medication known to affect protein and/or amino acid metabolism.
- Allergy to mycoprotein/Quorn/edible fungi, edible algae, lupin/legumes, or milk.
- Smoking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Bioavailability of the Sustainable, Non-animal Derived Protein Sources Mycoprotein, Spirulina, Chlorella, Pea and Lupin to Milk Protein in Healthy Older Adults
The progressive age-related loss of muscle mass is termed sarcopenia. Consequences of sarcopenia are, but not limited to, decreased muscle strength, frailty, and an increased risk for the development of chronic metabolic diseases. Impaired postprandial protein digestion and amino acid absorption with advancing age has been suggested to be a key mechanism underlying sarcopenia. To overcome age-related skeletal muscle atrophy, sufficient dietary protein intake is required. However, the production of animal-based protein sources, such as milk, is associated with a number of economic, environmental, and ethical issues. Accordingly, there is a need to develop sustainable dietary protein sources to support our nutrition. Mycoprotein, spirulina, chlorella, pea, and lupin are novel, sustainable, non-animal derived protein sources that may represent potential alternative protein sources. However, the efficacy of these sources to stimulate muscle mass growth in both young and older adults is unknown.
Therefore, the present study will investigate the postprandial bioavailability of mycoprotein, spirulina, chlorella, pea, and lupin protein when compared to the animal-derived milk protein. Moreover, postprandial protein handling of these novel protein sources across different ages will be assessed. Briefly, 12 healthy young, and older adults will visit the University for 6 separate test days, with each day lasting 6 hours. Participants will consume the one of the 6 protein drinks on each test day. Repeated blood sampling will be used to assess protein digestion and subsequent systemic amino acid appearance.
- Conditions
- Healthy Aging
- Being tested
- Protein ingestion
- Keywords
- Protein digestion, Amino acid absorption, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein ingestionDietary supplement
Ingestion of various sustainable non-animal derived protein sources compared to animal-based milk protein.
| Study group | Role | What they receive |
|---|---|---|
| Mycoprotein | Experimental | Ingestion of 30 g mycoprotein drink Receives: Dietary Supplement: Protein ingestion |
| Spirulina | Experimental | Ingestion of 30 g spirulina protein drink Receives: Dietary Supplement: Protein ingestion |
| Chlorella | Experimental | Ingestion of 30 g chlorella protein drink Receives: Dietary Supplement: Protein ingestion |
| Pea | Experimental | Ingestion of 30 g pea protein drink Receives: Dietary Supplement: Protein ingestion |
| Lupin | Experimental | Ingestion of 30 g lupin protein drink Receives: Dietary Supplement: Protein ingestion |
| Milk | Active comparator | Ingestion of 30 g milk protein Receives: Dietary Supplement: Protein ingestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma amino acid concentrations
Peak and total plasma amino acid concentrations following protein ingestion
Measured: 5 hours
Secondary outcomes (2)
Blood glucose
The levels of glucose in the blood following protein ingestion
Measured: 5 hours
Serum insulin
The levels of insulin in blood serum following protein ingestion
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start12 Nov 2019
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin T Wall, PhD, Principal investigator, Professor of Nutritional Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297137
- Sponsor's protocol ID
- 191023/A/09
- Acronym
- NOVA
- Status last verified
- Jan 2024
- First submitted
- 3 Mar 2020
- Last updated
- 11 Jan 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 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Bioavailability of the Sustainable, Non-animal Derived Protein Sources Mycoprotein, Spirulina, Chlorella, Pea and Lupin to Milk Protein in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT04297137
- Acronym / sponsor ID
- NOVA / 191023/A/09
- Conditions
- Healthy Aging
- Keywords
- Protein digestion, Amino acid absorption, Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 5 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.
The progressive age-related loss of muscle mass is termed sarcopenia. Consequences of sarcopenia are, but not limited to, decreased muscle strength, frailty, and an increased risk for the development of chronic metabolic diseases. Impaired postprandial protein digestion and amino acid absorption with advancing age has been suggested to be a key mechanism underlying sarcopenia. To overcome age-related skeletal muscle atrophy, sufficient dietary protein intake is required. However, the production of animal-based protein sources, such as milk, is associated with a number of economic, environmental, and ethical issues. Accordingly, there is a need to develop sustainable dietary protein sources to support our nutrition. Mycoprotein, spirulina, chlorella, pea, and lupin are novel, sustainable, non-animal derived protein sources that may represent potential alternative protein sources. However, the efficacy of these sources to stimulate muscle mass growth in both young and older adults is unknown.
Therefore, the present study will investigate the postprandial bioavailability of mycoprotein, spirulina, chlorella, pea, and lupin protein when compared to the animal-derived milk protein. Moreover, postprandial protein handling of these novel protein sources across different ages will be assessed. Briefly, 12 healthy young, and older adults will visit the University for 6 separate test days, with each day lasting 6 hours. Participants will consume the one of the 6 protein drinks on each test day. Repeated blood sampling will be used to assess protein digestion and subsequent systemic amino acid appearance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Mycoprotein | Experimental | Dietary Supplement: Protein ingestionIngestion of 30 g mycoprotein drink |
| Spirulina | Experimental | Dietary Supplement: Protein ingestionIngestion of 30 g spirulina protein drink |
| Chlorella | Experimental | Dietary Supplement: Protein ingestionIngestion of 30 g chlorella protein drink |
| Pea | Experimental | Dietary Supplement: Protein ingestionIngestion of 30 g pea protein drink |
| Lupin | Experimental | Dietary Supplement: Protein ingestionIngestion of 30 g lupin protein drink |
| Milk | Active comparator | Dietary Supplement: Protein ingestionIngestion of 30 g milk protein |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females aged 18-35 or 55 - 80 years old.
- Body mass index between 18.5 - 30.
Key exclusion criteria (7 listed)
- Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes).
- Any diagnosed cardiovascular disease or hypertension.
- Elevated blood pressure (>150/90 mmHg) at the time of screening.
- Known pre-existing liver disease/condition.
- Any medication known to affect protein and/or amino acid metabolism.
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 ingestionIngestion of various sustainable non-animal derived protein sources compared to animal-based milk protein. | Dietary supplement | Chlorella, Lupin, Milk, Mycoprotein, Pea, Spirulina |
Primary outcome
Plasma amino acid concentrations
Time frame: 5 hours
Peak and total plasma amino acid concentrations following protein ingestion
2 secondary outcomes
Blood glucose
Time frame: 5 hours
Serum insulin
Time frame: 5 hours
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 11 Jan 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.
Benjamin T Wall, PhD principal investigator
Professor of Nutritional Physiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein ingestion in people with 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 2 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 11 Jan 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?
Plasma amino acid concentrations (time frame: 5 hours). 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 11 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.