HealthyFUNNCT03659890
Dietary Nucleotides and Ribose on Muscle Fuel Utilisation
A study testing Low nucleotide, High nucleotide and High nucletide + Ribose in people with Healthy, run by University of Exeter at 1 site in United Kingdom.
Trial summary
Nucleotides are the building blocks for a variety of molecules, including ATP, which is broken down in the skeletal muscle cells to provide fuel for exercise. Nucleotides can be obtained from the diet, and produced or salvaged by the body. 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, High nucleotide and High nucletide + Ribose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2018to 2 Feb 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 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
- Muscle or bone injuries
- BMI < 18 or > 30
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Exeter - St Luke's Campus
Exeter, Devon, EX2 4TH
About this study
Official title: The Effect of Dietary Nucleotides and Ribose on Muscle Fuel Utilisation and Exercise Performance
Nucleotides are the building blocks for a variety of molecules, including ATP, which is broken down in the skeletal muscle cells to provide fuel for exercise. Nucleotides can be obtained from the diet, and produced or salvaged by the body. Though nucleotides provide the building blocks for ATP, the sugar ribose has been suggested to be rate limiting for synthesising ATP.
Previous studies have shown a decrease in ATP levels in the muscle after intense exercise, and this is linked to fatigue. Other studies have also reported benefits of nucleotide and/or ribose supplementation on exercise performance. However, any potential link between ATP metabolism and exercise performance has not been explored.
This study will look at the effects of nucleotide and nucleotide-ribose supplementation in fuel utilisation and performance in skeletal muscle during endurance exercise.
- Conditions
- Healthy
- Being tested
- Low nucleotide, High nucleotide, High nucletide + Ribose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low nucleotideDietary supplement
2 week, twice daily, supplementation with a nucleotide-depleted mycoprotein drink, with added dextrose
High nucleotideDietary supplement
2 week, twice daily, supplementation with a nucleotide-rich mycoprotein drink, with added dextrose
High nucletide + RiboseDietary supplement
2 week, twice daily, supplementation with a nucleotide-rich mycoprotein drink, with added ribose
| Study group | Role | What they receive |
|---|---|---|
| Low nucleotide | Placebo comparator | 2 week supplementation with a low nucleotide mycoprotein drink, with added dextrose Receives: Dietary Supplement: Low nucleotide |
| High nucleotide | Experimental | 2 week supplementation with a high nucleotide mycoprotein drink, with added dextrose Receives: Dietary Supplement: High nucleotide |
| High nucletide + Ribose | Experimental | 2 week supplementation with a high nucleotide mycoprotein drink, with added ribose Receives: Dietary Supplement: High nucletide + Ribose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in muscle ATP concentrations
Measured: After each supplementation cycle (day 15 of each cycle): baseline (fasted and before exercise), immediately after glycogen depleting exercise (after exercising for 1:30 - 2 hours), immediately after 15 minute time trial and after 3-hour recovery
Secondary outcomes (4)
Changes in muscle glycogen concentrations
Measured: After each supplementation cycle (day 15 of each cycle): baseline (fasted and before exercise), immediately after glycogen depleting exercise (after exercising for 1:30 - 2 hours), immediately after 15 minute time trial and after 3-hour recovery
Blood lactate concentrations
Measured: After supplementation cycle (day 15): baseline and at 15 minute intervals up 1 hour during glycogen depleting exercise
Blood glucose concentrations
Measured: After supplementation cycle (day 15): baseline and at 15 minute intervals up 1 hour during glycogen depleting exercise
Serum uric acid concentrations
Measured: Measured at baseline and of days 6, 8 and 15 of each supplementation cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start28 Jun 2018
- Primary completion2 Feb 2020
- Study completion2 Feb 2020
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
- 13 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
- NCT03659890
- Sponsor's protocol ID
- 171206/B/04
- Acronym
- FUN
- Status last verified
- Mar 2020
- First submitted
- 13 Jun 2018
- Last updated
- 26 Mar 2020
- 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 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Nucleotides and Ribose on Muscle Fuel Utilisation and Exercise Performance
- ClinicalTrials.gov ID
- NCT03659890
- Acronym / sponsor ID
- FUN / 171206/B/04
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 2 Feb 2020 (actual)
- Study completion
- 2 Feb 2020 (actual)
- First posted
- 6 Sep 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.
Nucleotides are the building blocks for a variety of molecules, including ATP, which is broken down in the skeletal muscle cells to provide fuel for exercise. Nucleotides can be obtained from the diet, and produced or salvaged by the body. Though nucleotides provide the building blocks for ATP, the sugar ribose has been suggested to be rate limiting for synthesising ATP.
Previous studies have shown a decrease in ATP levels in the muscle after intense exercise, and this is linked to fatigue. Other studies have also reported benefits of nucleotide and/or ribose supplementation on exercise performance. However, any potential link between ATP metabolism and exercise performance has not been explored.
This study will look at the effects of nucleotide and nucleotide-ribose supplementation in fuel utilisation and performance in skeletal muscle during endurance exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low nucleotide | Placebo comparator | Dietary Supplement: Low nucleotide2 week supplementation with a low nucleotide mycoprotein drink, with added dextrose |
| High nucleotide | Experimental | Dietary Supplement: High nucleotide2 week supplementation with a high nucleotide mycoprotein drink, with added dextrose |
| High nucletide + Ribose | Experimental | Dietary Supplement: High nucletide + Ribose2 week supplementation with a high nucleotide mycoprotein drink, with added ribose |
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
- Muscle or bone injuries
- 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 nucleotide2 week, twice daily, supplementation with a nucleotide-depleted mycoprotein drink, with added dextrose | Dietary supplement | Low nucleotide |
| High nucleotide2 week, twice daily, supplementation with a nucleotide-rich mycoprotein drink, with added dextrose | Dietary supplement | High nucleotide |
| High nucletide + Ribose2 week, twice daily, supplementation with a nucleotide-rich mycoprotein drink, with added ribose | Dietary supplement | High nucletide + Ribose |
Primary outcome
Changes in muscle ATP concentrations
Time frame: After each supplementation cycle (day 15 of each cycle): baseline (fasted and before exercise), immediately after glycogen depleting exercise (after exercising for 1:30 - 2 hours), immediately after 15 minute time trial and after 3-hour recovery
4 secondary outcomes
Changes in muscle glycogen concentrations
Time frame: After each supplementation cycle (day 15 of each cycle): baseline (fasted and before exercise), immediately after glycogen depleting exercise (after exercising for 1:30 - 2 hours), immediately after 15 minute time trial and after 3-hour recovery
Blood lactate concentrations
Time frame: After supplementation cycle (day 15): baseline and at 15 minute intervals up 1 hour during glycogen depleting exercise
Blood glucose concentrations
Time frame: After supplementation cycle (day 15): baseline and at 15 minute intervals up 1 hour during glycogen depleting exercise
Serum uric acid concentrations
Time frame: Measured at baseline and of days 6, 8 and 15 of each supplementation cycle
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 Mar 2020.
- 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, High nucleotide and High nucletide + Ribose 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 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 26 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. 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 muscle ATP concentrations (time frame: After each supplementation cycle (day 15 of each cycle): baseline (fasted and before exercise), immediately after glycogen depleting exercise (after exercising for 1:30 - 2 hours), immediately after 15 minute time trial and after 3-hour recovery). 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 Mar 2020.