HealthyTIDENCT03568864
High Nucleotide Meal Consumption in Uric Acid and Metabolic Health
A study testing Low nucleotide meal and High nucleotide meal in people with Healthy, run by University of Exeter at 1 site in United Kingdom.
Trial summary
The production of protein rich animal products is associated with a large environmental burden, and with ethical considerations. Additionally, the over-consumption of meat might be associated with detrimental effects to health. 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?
- Low nucleotide meal and High nucleotide meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jul 2017to 14 Mar 2018
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Luke's Campus - University of Exeter
Exeter, Devon, EX1 2LU
About this study
Official title: The Acute Effect of a High Nucleotide Mycoprotein Meal in Uric Acid Concentrations and Other Markers of Health
The production of protein rich animal products is associated with a large environmental burden, and with ethical considerations. Additionally, the over-consumption of meat might be associated with detrimental effects to health.
Using mycoprotein, a food ingredient derived from the fermentation of a fungus, as a meat substitute could result in environmental benefits, and could have a role in managing obesity, diabetes and improving metabolic health. However, naturally produced mycoprotein has a high nucleotide content and little is known about the impact of nucleotides in uric acid levels and other health markers.
The aim of this study is to investigate the effect of a meal based on nucleotide rich mycoprotein on uric acid concentrations and other markers of health.
- Conditions
- Healthy
- Being tested
- Low nucleotide meal, High nucleotide meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low nucleotide mealOther
The participants will consume a mixed meal (sandwich) containing a nucleotide depleted mycoprotein product (low in nucleotides)
High nucleotide mealOther
The participants will consume a mixed meal (sandwich) containing a non nucleotide depleted mycoprotein product (high in nucleotides)
| Study group | Role | What they receive |
|---|---|---|
| Low nucleotide meal | Placebo comparator | Mixed meal containing mycoprotein with a reduced nucleotide content (~ 2% nucleotides) Receives: Other: Low nucleotide meal |
| High nucleotide meal | Experimental | Mixed meal containing mycoprotein with a high nucleotide content (~ 10% nucleotides) Receives: Other: High nucleotide meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum uric acid concentrations over a 24 h period
Measured: Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal; 8, 12 and 24 hours after meal
Secondary outcomes (3)
Blood glucose
Measured: Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal; 24 hours after meal
Serum insulin
Measured: Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal
Branched chained amino-acids
Measured: Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start31 Jul 2017
- Primary completion14 Mar 2018
- Study completion14 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 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
- NCT03568864
- Sponsor's protocol ID
- 170712/A/01
- Acronym
- TIDE
- Status last verified
- Jun 2018
- First submitted
- 31 May 2018
- Last updated
- 26 Jun 2018
- 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 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of a High Nucleotide Mycoprotein Meal in Uric Acid Concentrations and Other Markers of Health
- ClinicalTrials.gov ID
- NCT03568864
- Acronym / sponsor ID
- TIDE / 170712/A/01
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 14 Mar 2018 (actual)
- First posted
- 26 Jun 2018 (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 production of protein rich animal products is associated with a large environmental burden, and with ethical considerations. Additionally, the over-consumption of meat might be associated with detrimental effects to health.
Using mycoprotein, a food ingredient derived from the fermentation of a fungus, as a meat substitute could result in environmental benefits, and could have a role in managing obesity, diabetes and improving metabolic health. However, naturally produced mycoprotein has a high nucleotide content and little is known about the impact of nucleotides in uric acid levels and other health markers.
The aim of this study is to investigate the effect of a meal based on nucleotide rich mycoprotein on uric acid concentrations and other markers of health.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low nucleotide meal | Placebo comparator | Other: Low nucleotide mealMixed meal containing mycoprotein with a reduced nucleotide content (~ 2% nucleotides) |
| High nucleotide meal | Experimental | Other: High nucleotide mealMixed meal containing mycoprotein with a high nucleotide content (~ 10% nucleotides) |
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 (4 listed)
- On medication (except contraception)
- Smokers
- Diagnosed with any metabolic or cardiovascular conditions
- BMI < 18 or > 30
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 |
|---|---|---|
| Low nucleotide mealThe participants will consume a mixed meal (sandwich) containing a nucleotide depleted mycoprotein product (low in nucleotides) | Other | Low nucleotide meal |
| High nucleotide mealThe participants will consume a mixed meal (sandwich) containing a non nucleotide depleted mycoprotein product (high in nucleotides) | Other | High nucleotide meal |
Primary outcome
Changes in serum uric acid concentrations over a 24 h period
Time frame: Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal; 8, 12 and 24 hours after meal
3 secondary outcomes
Blood glucose
Time frame: Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal; 24 hours after meal
Serum insulin
Time frame: Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal
Branched chained amino-acids
Time frame: Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal
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 26 Jun 2018.
- 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 testing Low nucleotide meal and High nucleotide meal in people with Healthy, 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 1 inclusion and 4 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 26 Jun 2018. 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. 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?
Changes in serum uric acid concentrations over a 24 h period (time frame: Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal; 8, 12 and 24 hours after meal). 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 26 Jun 2018.