Status:
NOT_YET_RECRUITING
Bath Myorhythms Project
Lead Sponsor:
University of Bath
Collaborating Sponsors:
University of Surrey
Maastricht University
Conditions:
Metabolic Regulation
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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 w...
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 monitor...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
May 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06997315
Start Date
May 23 2025
End Date
November 1 2027
Last Update
May 30 2025
Active Locations (1)
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1
University of Bath
Bath, United Kingdom, BA2 7AY