Metabolic RegulationNCT06997315
Bath Myorhythms Project
A study testing Time of exercise and No exercise in people with Metabolic Regulation, run by University of Bath at 1 site in United Kingdom.
Trial summary
Human Physiology is coordinated by a circadian timing system that synchronises daily cycles of light-dark, wake- sleep, activity-rest and feeding-fasting. The alignment of these behavioural patterns with underlying biological rhythms is closely linked to physiological function, with misalignment linked to chronic… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Regulation
- What is being tested?
- Time of exercise and No exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 May 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women and men - with targeted recruitment to encourage females to volunteer given previous recruitment rates; anticipating fewer women than men, sex will also be included as a strata in the randomisation plan to favour the few who do volunteer being relatively evenly distributed between conditions.
- A body mass index of >18 and <35 kg•m-2.
- Minimum absolute body mass of 67 kg (to accommodate the required dose of lidocaine for 7 biopsies, plus additional for pre-incisions)
- be between 18-50 years of age
- Premenopausal women
- Metabolically healthy (free from diagnosed metabolic illness or family history of type II diabetes
Show all 16Show fewer
- be able and willing to give informed oral and written consent,
- complete and meet the defined criteria of pre-study questionnaires and screens
- have a regular sleep cycle with a sleep duration between 6 and 8 h
- do not exhibit extreme morning or evening preference (Horne and Ostberg, 1976)
- agree to keep a constant sleep/wake cycle with a self-selected 8-h duration in bed/dark trying to sleep (from which it cannot be deviated by more than 30 minutes) for one week prior to the lab study
- obtain 15 minutes of sunlight within 1.5 hours of waking up and agree to nap only within a 4 h designated nap window for one week prior to the lab study
- allow confirmation of compliance to these instructions by wearing ActiHeart and light monitors continuously and complete daily sleep and event diaries for one week before the study session
- agree to refrain from alcohol, caffeine, strenuous exercise and certain food components for one day before the study session
- agree to weigh and record daily meals (based on individual energy requirements) for TWO days prior to the study
- agree to refrain from prescribed and 'over the counter' medication and food/vitamin supplements for a wash-out period three weeks before and during the study IF the drug is deemed to affect study outcomes and may safely be withheld for that period.
Who cannot join
- are taking regular medication (also non-prescribed) or food supplements (e.g. vitamins, minerals, fish oil, antioxidant tablets) from which it is not possible to refrain, known to influence: sleep/alertness/the circadian timing system (e.g. beta-blockers, barbituates, antidepressants, benzodiazepines, melatonin, ritalin, modafinil, soporifics, St John's Wort), any of the metabolic functions (e.g. affecting thyroid, kidney, liver or gastrointestinal function) any of the inflammatory markers (e.g. aspirin, ibuprofen, antibiotics, hay fever medication, medication for sore throats and colds), and/or any of the endothelial markers (e.g. ACE inhibitors and angiotensin (receptor) blockers, diuretics, beta-blockers, anti-thrombosis medication), any anticoagulant medication
- have a history of any circadian or sleep disorder or metabolic, cardiovascular or chronic infectious / inflammatory disease as confirmed by the GP or the pre-study questionnaires (e.g. a Pittsburgh Sleep Quality Index > 5 will result in exclusion)
- have a history of psychiatric or neurological disease or drug and alcohol abuse
- have donated over 400 ml of blood in the three months preceding the study
- have participated in shift work (regularly working past a typical bed time of 2300 h) or have travelled across more than two time zones within three weeks before the study
- do not keep a regular sleep-wake cycle
Show all 10Show fewer
- do not refrain from alcohol, caffeine containing drinks (e.g. coffee, coke, tea, Red Bull), strenuous exercise and certain foods (e.g. those high in fat and green vegetables) for one day before and during the laboratory session
- regularly consume more than 4 cups of caffeinated beverages (e.g. tea, coffee, cola) daily
- smokers
- have a known lidocaine allergy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Bath
Bath, BA2 7AY
James A Betts, PhD, jb335@bath.ac.uk
About this study
Official title: Bath MyoRhythms Project (BMP): Characterising Rhythmicity in Human Skeletal Muscle Metabolism
Human Physiology is coordinated by a circadian timing system that synchronises daily cycles of light-dark, wake- sleep, activity-rest and feeding-fasting. The alignment of these behavioural patterns with underlying biological rhythms is closely linked to physiological function, with misalignment linked to chronic metabolic diseases.
The vast majority of evidence about rhythms in metabolism comes from studies of rodents, which is remarkable given that rodents differ fundamentally from humans in both behaviour and metabolic regulation. Moreover, almost no research in any species has examined the effects of muscle contractile activity on 24-h rhythms in metabolism. Skeletal muscle is a key site of metabolic regulation and contractile activity is a powerful stimulus to increase metabolism. The researchers have established a novel protocol for serial muscle sampling throughout 24 hours and pilot work completed in preparation for this grant revealed diurnal transcriptomic and lipidomic rhythms in human skeletal muscle. Further development of that protocol has used enteral feeding via a tube which delivers nutrient directly to the stomach to enable constant nutrient delivery (including during sleep), with preliminary data indicating that underlying rhythms in metabolism are responsive to nutrient availability patterns.
The researchers will now capitalise on those findings by incorporating multiple isotope tracers within the protocol, thus finally documenting the nature of rhythmic flux in carbohydrate metabolism and protein turnover in human skeletal muscle, and how those rhythms are aligned with timing and patterns of exercise. In summary, participants will stay in the laboratory for 36 hours with 24 hours of constant feeding via nasogastric tube, and muscle and blood sampling. Participants will be allocated to either the early or late exercise group (involving 1 hour of cycling at either 0800 or 2000 h, respectively) or the control group who will rest for the 24 hours.
Read the detailed description
Once eligibility has been verified, participants will attend the laboratory for preliminary testing which will include a submaximal exercise test on an exercise bike. Participants will then be monitored for one-week ahead of their main laboratory visit and will adhere to pre-trial dietary and lifestyle controls for the final 48 h of the pre-trial week (including records of wake/sleep cycles and weighed-food diaries, along with wearable technologies to continuously monitor physical activity, light exposure and sub-cutaneous interstitial glucose concentrations) and standardised meals will be provided to all participants for the 24 h ahead of laboratory visits.
Participants will arrive in the laboratory at 1900 h (DAY 1) the day before the 24-h monitoring period to consume a standardised evening meal (baked potato, beans, broccoli). A cannula will be fitted to an antecubital vein prior and participants will sleep in the laboratory ready for monitoring to commence upon waking the next morning (DAY 2).
At 0600 h, whilst the participant remains asleep, infusion of labelled protein and glucose will be commenced to achieve steady state before starting the sampling period and to allow measurement of protein and glucose metabolism. Resting metabolic rate (the amount of energy required at rest) will be measured immediately upon waking by collecting expired breath samples. Specifically, expired gases will be collected for 20-30 minutes using the gold-standard Douglas bag technique. This measured value will then be used to individually prescribe the energy requirements to be met via nasogastric feeding. A second cannula will then be fitted and a nasogastric tube will be inserted through the nose into the stomach to commence delivery of a nutritionally balanced meal-replacement solution at 0800 h which will be delivered continuously throughout the 24 hour monitoring period. A muscle sample will be obtained at 0730. Participants in the early exercise group will commence 1 hour of exercise at a moderate intensity with 1-min expired breath samples and blood samples collected every 15 minutes and heart rate monitored throughout to verify the exercise intensity.
Further muscle samples will be obtained at 4-h intervals to allow for 7 time-points ending at the final sample at 0800 h the next morning (DAY 3) and blood sampling will occur hourly. The inactive group will follow the same sampling schedule without the exercise. The late exercise group will adhere to the same series of events as described above but with a 12-h delayed shift in time of day. Upon completion of those final tissue samples, participants will be provided with the same breakfast as they had been provided on DAY 1 as part of their dietary standardisation and they will be issued with the same lunch as was consumed on DAY 1 to take away. All wearable devices other than the continuous glucose monitor will then be removed before the participant leaves the laboratory. Body temperature will also be measured throughout the protocol via ingestible thermometers.
- Conditions
- Metabolic Regulation
- Being tested
- Time of exercise, No exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time of exerciseOther
The intervention is 1 hour of exercise at 50% between lactate threshold 1 and 2 either in the morning or the evening at the start of the 24 hour sampling period.
No exerciseOther
The participants will rest for the full 24 hour sampling period.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Other: No exercise |
| Early exercise | Experimental | Not described Receives: Other: Time of exercise |
| Late exercise | Experimental | Not described Receives: Other: Time of exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbohydrate flux
Rates of exogenous glucose appearance, endogenous glucose production, total carbohydrate oxidation, exogenous carbohydrate oxidation and net glycogen degradation in muscle biopsies over 24 hours
Measured: 24 hours
Skeletal muscle protein synthesis
Plasma amino acid concentrations derived from the L-[ring-13C]-phenylalanine infusion over 24 hours.
Measured: 24 hours
Skeletal muscle protein synthesis
Protein fractional synthetic rates in muscle samples derived from the L-[ring-13C]-phenylalanine infusion over 24 hours.
Measured: 24 hours
Secondary outcomes (19)
Mass spectrometry phosphoproteomics
Mass spectrometry phosphoproteomics from skeletal muscle biopsies over 24 hours.
Measured: 24 hours
Protein content of proteins involved in insulin signalling, glucose transport and protein synthesis.
The content of proteins involved in insulin signalling, glucose transport and protein synthesis determined by semi-quantitative western blotting in skeletal muscle biopsies over 24 hours.
Measured: 24 hours.
Skeletal muscle gene expression
Transcriptomic and targeted quantitative real-time PCR TaqMan analyses of skeletal muscle gene expression from muscle biopsies over 24 hours.
Measured: 24 hours
Intramuscular metabolites
Liquid chromatography-mass spectrometry to quantify circulating and intramuscular metabolites indicative of carbohydrate, lipid and amino acid metabolism in skeletal muscle biopsies over 24 hours.
Measured: 24 hours
Intramuscular enzymes
Liquid chromatography-mass spectrometry to quantify the activation of intramuscular enzymes involved in the formation of acetyl-CoA in skeletal muscle biopsies over 24 hours.
Measured: 24 hours
Plasma glucose concentrations
Plasma glucose concentrations over 24 hours.
Measured: 24 hours
Plasma non-esterified fatty acid concentrations
Plasma non-esterified fatty acid concentrations over 24 hours
Measured: 24 hours
Plasma glycerol concentrations
Plasma glycerol concentrations over 24 hours
Measured: 24 hours
Plasma triacylglycerol concentrations
Plasma triacylglycerol concentrations over 24 hours
Measured: 24 hours
Plasma urea concentrations
Plasma urea concentrations over 24 hours
Measured: 24 hours
Plasma insulin concentrations
Plasma insulin concentrations over 24 hours
Measured: 24 hours
Plasma glucagon-like peptide-1 concentrations
Plasma glucagon-like peptide-1 concentrations over 24 hours
Measured: 24 hours
Plasma insulin-like growth factor 1 concentrations
Plasma insulin-like growth factor 1 concentrations over 24 hours
Measured: 24 hours
Plasma gastric inhibitory polypeptide concentrations
Plasma gastric inhibitory polypeptide concentrations over 24 hours
Measured: 24 hours
Plasma peptide YY concentrations
Plasma peptide YY concentrations over 24 hours
Measured: 24 hours
Plasma cortisol concentrations
Plasma cortisol concentrations over 24 hours
Measured: 24 hours
Plasma total ghrelin concentrations
Plasma total ghrelin concentrations over 24 hours
Measured: 24 hours
Plasma leptin concentrations
Plasma leptin concentrations over 24 hours
Measured: 24 hours
Plasma melatonin concentrations
Plasma melatonin concentrations over 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start23 May 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic RegulationStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- University of Surrey, Maastricht University, University of Copenhagen, University of Nottingham, Australian Catholic University, University of Geneva, Switzerland
- Responsible party
- Principal investigator, James Betts, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997315
- Sponsor's protocol ID
- 7560-9757
- Status last verified
- May 2026
- First submitted
- 22 Apr 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bath MyoRhythms Project (BMP): Characterising Rhythmicity in Human Skeletal Muscle Metabolism
- ClinicalTrials.gov ID
- NCT06997315
- Acronym / sponsor ID
- 7560-9757
- Conditions
- Metabolic Regulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- University of Surrey, Maastricht University, University of Copenhagen, University of Nottingham, Australian Catholic University, University of Geneva, Switzerland
- Study start
- 23 May 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 30 May 2025 (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.
Human Physiology is coordinated by a circadian timing system that synchronises daily cycles of light-dark, wake- sleep, activity-rest and feeding-fasting. The alignment of these behavioural patterns with underlying biological rhythms is closely linked to physiological function, with misalignment linked to chronic metabolic diseases.
The vast majority of evidence about rhythms in metabolism comes from studies of rodents, which is remarkable given that rodents differ fundamentally from humans in both behaviour and metabolic regulation. Moreover, almost no research in any species has examined the effects of muscle contractile activity on 24-h rhythms in metabolism. Skeletal muscle is a key site of metabolic regulation and contractile activity is a powerful stimulus to increase metabolism. The researchers have established a novel protocol for serial muscle sampling throughout 24 hours and pilot work completed in preparation for this grant revealed diurnal transcriptomic and lipidomic rhythms in human skeletal muscle. Further development of that protocol has used enteral feeding via a tube which delivers nutrient directly to the stomach to enable constant nutrient delivery (including during sleep), with preliminary data indicating that underlying rhythms in metabolism are responsive to nutrient availability patterns.
The researchers will now capitalise on those findings by incorporating multiple isotope tracers within the protocol, thus finally documenting the nature of rhythmic flux in carbohydrate metabolism and protein turnover in human skeletal muscle, and how those rhythms are aligned with timing and patterns of exercise. In summary, participants will stay in the laboratory for 36 hours with 24 hours of constant feeding via nasogastric tube, and muscle and blood sampling. Participants will be allocated to either the early or late exercise group (involving 1 hour of cycling at either 0800 or 2000 h, respectively) or the control group who will rest for the 24 hours.
Detailed description
Once eligibility has been verified, participants will attend the laboratory for preliminary testing which will include a submaximal exercise test on an exercise bike. Participants will then be monitored for one-week ahead of their main laboratory visit and will adhere to pre-trial dietary and lifestyle controls for the final 48 h of the pre-trial week (including records of wake/sleep cycles and weighed-food diaries, along with wearable technologies to continuously monitor physical activity, light exposure and sub-cutaneous interstitial glucose concentrations) and standardised meals will be provided to all participants for the 24 h ahead of laboratory visits.
Participants will arrive in the laboratory at 1900 h (DAY 1) the day before the 24-h monitoring period to consume a standardised evening meal (baked potato, beans, broccoli). A cannula will be fitted to an antecubital vein prior and participants will sleep in the laboratory ready for monitoring to commence upon waking the next morning (DAY 2).
At 0600 h, whilst the participant remains asleep, infusion of labelled protein and glucose will be commenced to achieve steady state before starting the sampling period and to allow measurement of protein and glucose metabolism. Resting metabolic rate (the amount of energy required at rest) will be measured immediately upon waking by collecting expired breath samples. Specifically, expired gases will be collected for 20-30 minutes using the gold-standard Douglas bag technique. This measured value will then be used to individually prescribe the energy requirements to be met via nasogastric feeding. A second cannula will then be fitted and a nasogastric tube will be inserted through the nose into the stomach to commence delivery of a nutritionally balanced meal-replacement solution at 0800 h which will be delivered continuously throughout the 24 hour monitoring period. A muscle sample will be obtained at 0730. Participants in the early exercise group will commence 1 hour of exercise at a moderate intensity with 1-min expired breath samples and blood samples collected every 15 minutes and heart rate monitored throughout to verify the exercise intensity.
Further muscle samples will be obtained at 4-h intervals to allow for 7 time-points ending at the final sample at 0800 h the next morning (DAY 3) and blood sampling will occur hourly. The inactive group will follow the same sampling schedule without the exercise. The late exercise group will adhere to the same series of events as described above but with a 12-h delayed shift in time of day. Upon completion of those final tissue samples, participants will be provided with the same breakfast as they had been provided on DAY 1 as part of their dietary standardisation and they will be issued with the same lunch as was consumed on DAY 1 to take away. All wearable devices other than the continuous glucose monitor will then be removed before the participant leaves the laboratory. Body temperature will also be measured throughout the protocol via ingestible thermometers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: No exercise |
| Early exercise | Experimental | Other: Time of exercise |
| Late exercise | Experimental | Other: Time of exercise |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Women and men - with targeted recruitment to encourage females to volunteer given previous recruitment rates; anticipating fewer women than men, sex will also be included as a strata in the randomisation plan to favour the few who do volunteer being relatively evenly distributed between conditions.
- A body mass index of >18 and <35 kg•m-2.
- Minimum absolute body mass of 67 kg (to accommodate the required dose of lidocaine for 7 biopsies, plus additional for pre-incisions)
- be between 18-50 years of age
- Premenopausal women
Key exclusion criteria (10 listed)
- are taking regular medication (also non-prescribed) or food supplements (e.g. vitamins, minerals, fish oil, antioxidant tablets) from which it is not possible to refrain, known to influence: sleep/alertness/the circadian timing system (e.g. beta-blockers, barbituates, antidepressants, benzodiazepines, melatonin, ritalin, modafinil, soporifics, St John's Wort), any of the metabolic functions (e.g. affecting thyroid, kidney, liver or gastrointestinal function) any of the inflammatory markers (e.g. aspirin, ibuprofen, antibiotics, hay fever medication, medication for sore throats and colds), and/or any of the endothelial markers (e.g. ACE inhibitors and angiotensin (receptor) blockers, diuretics, beta-blockers, anti-thrombosis medication), any anticoagulant medication
- have a history of any circadian or sleep disorder or metabolic, cardiovascular or chronic infectious / inflammatory disease as confirmed by the GP or the pre-study questionnaires (e.g. a Pittsburgh Sleep Quality Index > 5 will result in exclusion)
- have a history of psychiatric or neurological disease or drug and alcohol abuse
- have donated over 400 ml of blood in the three months preceding the study
- have participated in shift work (regularly working past a typical bed time of 2300 h) or have travelled across more than two time zones within three weeks before the study
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 |
|---|---|---|
| Time of exerciseThe intervention is 1 hour of exercise at 50% between lactate threshold 1 and 2 either in the morning or the evening at the start of the 24 hour sampling period. | Other | Early exercise, Late exercise |
| No exerciseThe participants will rest for the full 24 hour sampling period. | Other | Control |
Primary outcome
Carbohydrate flux
Time frame: 24 hours
Rates of exogenous glucose appearance, endogenous glucose production, total carbohydrate oxidation, exogenous carbohydrate oxidation and net glycogen degradation in muscle biopsies over 24 hours
Skeletal muscle protein synthesis
Time frame: 24 hours
Plasma amino acid concentrations derived from the L-[ring-13C]-phenylalanine infusion over 24 hours.
Skeletal muscle protein synthesis
Time frame: 24 hours
Protein fractional synthetic rates in muscle samples derived from the L-[ring-13C]-phenylalanine infusion over 24 hours.
19 secondary outcomes
Mass spectrometry phosphoproteomics
Time frame: 24 hours
Protein content of proteins involved in insulin signalling, glucose transport and protein synthesis.
Time frame: 24 hours.
Skeletal muscle gene expression
Time frame: 24 hours
Intramuscular metabolites
Time frame: 24 hours
Intramuscular enzymes
Time frame: 24 hours
Plasma glucose concentrations
Time frame: 24 hours
Plasma non-esterified fatty acid concentrations
Time frame: 24 hours
Plasma glycerol concentrations
Time frame: 24 hours
Plasma triacylglycerol concentrations
Time frame: 24 hours
Plasma urea concentrations
Time frame: 24 hours
Plasma insulin concentrations
Time frame: 24 hours
Plasma glucagon-like peptide-1 concentrations
Time frame: 24 hours
Plasma insulin-like growth factor 1 concentrations
Time frame: 24 hours
Plasma gastric inhibitory polypeptide concentrations
Time frame: 24 hours
Plasma peptide YY concentrations
Time frame: 24 hours
Plasma cortisol concentrations
Time frame: 24 hours
Plasma total ghrelin concentrations
Time frame: 24 hours
Plasma leptin concentrations
Time frame: 24 hours
Plasma melatonin concentrations
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time of exercise and No exercise in people with Metabolic Regulation, run by University of Bath 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 16 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 11 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James A Betts, PhD (01225 383 448, jb335@bath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carbohydrate flux (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 May 2026.