Bath Myorhythms Project

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Bath

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Time of exercise

    Other intervention

    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 exercise

    Other intervention

    The participants will rest for the full 24 hour sampling period.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: Early exerciseExperimental treatment 1 intervention
Group C: Late exerciseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
24 hours
2

Skeletal muscle protein synthesis

Plasma amino acid concentrations derived from the L-\[ring-13C\]-phenylalanine infusion over 24 hours.

Time frame
24 hours
3

Skeletal muscle protein synthesis

Protein fractional synthetic rates in muscle samples derived from the L-\[ring-13C\]-phenylalanine infusion over 24 hours.

Time frame
24 hours

Secondary outcomes

1

Mass spectrometry phosphoproteomics

Mass spectrometry phosphoproteomics from skeletal muscle biopsies over 24 hours.

Time frame
24 hours
2

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.

Time frame
24 hours.
3

Skeletal muscle gene expression

Transcriptomic and targeted quantitative real-time PCR TaqMan analyses of skeletal muscle gene expression from muscle biopsies over 24 hours.

Time frame
24 hours
4

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.

Time frame
24 hours

Other outcomes

1

Skeletal muscle lipid concentrations

Skeletal muscle lipid concentrations using lipidomics of muscle biopsy samples over 24 hours

Time frame
24 hours
2

Blood cell counts

Plasma blood cell counts (i.e. leukocytes and subsets, erythrocytes and platelets) over 24 hours.

Time frame
24 hours
3

Skeletal muscle autophagic flux

Protein content of proteins involved in skeletal muscle autophagic flux determined by semi-quantitative western blotting in muscle biopsy samples over 24 hours.

Time frame
24 hours
4

Polysomnography profile

During 11 hours of sleep during pre-trial monitoring and intervention.

Time frame
11 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bath

Lead sponsor

University of Surrey

Collaborator

Maastricht University

Collaborator

University of Copenhagen

Collaborator

University of Nottingham

Collaborator

Australian Catholic University

Collaborator

University of Geneva, Switzerland

Collaborator