HealthyMYTHNCT02984358
Chronic Mycoprotein Consumption and Nucleotide Content in Metabolic Health
A study testing Animal protein based diet, Low-nucleotide mycoprotein based diet and High-nucleotide mycoprotein based diet in people with Healthy, run by University of Exeter.
Trial summary
Compare chronic (one week) of a 'normal' meat diet with one week of mycoprotein consumption, with or without a reduced nucleotide content, on markers of metabolic health, such as uric acid concentrations, blood glucose control and blood lipid profiles. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Animal protein based diet, Low-nucleotide mycoprotein based diet and High-nucleotide mycoprotein based diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2017
- 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
- BMI between 18 and 30
Who cannot join
- On medication (except contraception)
- Smokers
- Diagnosed with any metabolic or cardiovascular conditions
- BMI < 18 or > 30
- Dietary restrictions (vegetarians/vegans, etc.)
About this study
Official title: Effect of Chronic Mycoprotein Consumption, and of Its Nucleotide Content, in Uric Acid Concentrations and Other Markers of Metabolic Health in Adults
Compare chronic (one week) of a 'normal' meat diet with one week of mycoprotein consumption, with or without a reduced nucleotide content, on markers of metabolic health, such as uric acid concentrations, blood glucose control and blood lipid profiles.
- Conditions
- Healthy
- Being tested
- Animal protein based diet, Low-nucleotide mycoprotein based diet, High-nucleotide mycoprotein based diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal protein based dietOther
Low-nucleotide mycoprotein based dietOther
High-nucleotide mycoprotein based dietOther
| Study group | Role | What they receive |
|---|---|---|
| Animal protein based diet | Placebo comparator | Seven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by animal products (meat and fish). Receives: Other: Animal protein based diet |
| Low-nucleotide mycoprotein based diet | Active comparator | Seven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by nucleotide-depleted mycoprotein products (commercial Quorn products). Receives: Other: Low-nucleotide mycoprotein based diet |
| High-nucleotide mycoprotein based diet | Active comparator | Seven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by nucleotide-rich mycoprotein products. Receives: Other: High-nucleotide mycoprotein based diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum uric acid concentrations
Measured: Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)
Secondary outcomes (4)
Glycaemia and serum insulin - insulin sensitivity (oral glucose tolerance test)
Measured: Measured at baseline and after 1 week intervention (day 8)
IL-6
Measured: Measured at baseline and after 1 week intervention (day 8)
24 h blood glucose homeostasis - measured using a Dexcom CGMS
Measured: Measured 5 days at baseline (habitual data) and 5 days during the intervention (days 3 - 7)
Metabolomics (using Nuclear Magnetic Resonance - NMR)
Measured: Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2017
- Study completionDec 2017
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 HealthyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT02984358
- Sponsor's protocol ID
- 660065613
- Acronym
- MYTH
- Status last verified
- Jun 2018
- First submitted
- 2 Dec 2016
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coelho MOC, Monteyne AJ, Kamalanathan ID, Najdanovic-Visak V, Finnigan TJA, Stephens FB, Wall BT. High dietary nucleotide consumption for one week increases circulating uric acid concentrations but does not compromise metabolic health: A randomised controlled trial. Clin Nutr ESPEN. 2022 Jun;49:40-52. doi: 10.1016/j.clnesp.2022.04.022. Epub 2022 Apr 25.
PubMed 35623844
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chronic Mycoprotein Consumption, and of Its Nucleotide Content, in Uric Acid Concentrations and Other Markers of Metabolic Health in Adults
- ClinicalTrials.gov ID
- NCT02984358
- Acronym / sponsor ID
- MYTH / 660065613
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 Dec 2016 (estimated)
- 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.
Compare chronic (one week) of a 'normal' meat diet with one week of mycoprotein consumption, with or without a reduced nucleotide content, on markers of metabolic health, such as uric acid concentrations, blood glucose control and blood lipid profiles.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Animal protein based diet | Placebo comparator | Other: Animal protein based dietSeven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by animal products (meat and fish). |
| Low-nucleotide mycoprotein based diet | Active comparator | Other: Low-nucleotide mycoprotein based dietSeven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by nucleotide-depleted mycoprotein products (commercial Quorn products). |
| High-nucleotide mycoprotein based diet | Active comparator | Other: High-nucleotide mycoprotein based dietSeven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by nucleotide-rich mycoprotein products. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI between 18 and 30
Key exclusion criteria (5 listed)
- On medication (except contraception)
- Smokers
- Diagnosed with any metabolic or cardiovascular conditions
- BMI < 18 or > 30
- Dietary restrictions (vegetarians/vegans, etc.)
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 |
|---|---|---|
| Animal protein based diet | Other | Animal protein based diet |
| Low-nucleotide mycoprotein based diet | Other | Low-nucleotide mycoprotein based diet |
| High-nucleotide mycoprotein based diet | Other | High-nucleotide mycoprotein based diet |
Primary outcome
Serum uric acid concentrations
Time frame: Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)
4 secondary outcomes
Glycaemia and serum insulin - insulin sensitivity (oral glucose tolerance test)
Time frame: Measured at baseline and after 1 week intervention (day 8)
IL-6
Time frame: Measured at baseline and after 1 week intervention (day 8)
24 h blood glucose homeostasis - measured using a Dexcom CGMS
Time frame: Measured 5 days at baseline (habitual data) and 5 days during the intervention (days 3 - 7)
Metabolomics (using Nuclear Magnetic Resonance - NMR)
Time frame: Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)
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 15 Jun 2018.
- Derived from this study: PubMed 35623844Coelho MOC, Monteyne AJ, Kamalanathan ID, Najdanovic-Visak V, Finnigan TJA, Stephens FB, Wall BT. High dietary nucleotide consumption for one week increases circulating uric acid concentrations but does not compromise metabolic health: A randomised controlled trial. Clin Nutr ESPEN. 2022 Jun;49:40-52. doi: 10.1016/j.clnesp.2022.04.022. Epub 2022 Apr 25.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Animal protein based diet, Low-nucleotide mycoprotein based diet and High-nucleotide mycoprotein based diet in people with Healthy, run by University of Exeter.
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 1 inclusion and 5 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 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Serum uric acid concentrations (time frame: Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)). 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 NCT02984358, 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 15 Jun 2018.