title: Bath Breakfast Project (BBP)--examining the role of extended daily fasting in human energy balance and associated health outcomes: study protocol for a randomised controlled trial [ISRCTN31521726].
abstract: BACKGROUND
  Current guidance regarding the role of daily breakfast in human health is largely grounded in cross-sectional observations. However, the causal nature of these relationships has not been fully explored and what limited information is emerging from controlled laboratory-based experiments appears inconsistent with much existing data. Further progress in our understanding therefore requires a direct examination of how daily breakfast impacts human health under free-living conditions.
  
  
  METHODS
  The Bath Breakfast Project (BBP) is a randomised controlled trial comparing the effects of daily breakfast consumption relative to extended fasting on energy balance and human health. Approximately 70 men and women will undergo extensive laboratory-based assessments of their acute metabolic responses under fasted and post-prandial conditions, to include: resting metabolic rate, substrate oxidation, dietary-induced thermogenesis and systemic concentrations of key metabolites/hormones. Physiological and psychological indices of appetite will also be monitored both over the first few hours of the day (i.e. whether fed or fasted) and also following a standardised test lunch used to assess voluntary energy intake under controlled conditions. Baseline measurements of participants' anthropometric characteristics (e.g. DEXA) will be recorded prior to intervention, along with an oral glucose tolerance test and acquisition of adipose tissue samples to determine expression of key genes and estimates of tissue-specific insulin action. Participants will then be randomly assigned either to a group prescribed an energy intake of ≥3000 kJ before 1100 each day or a group to extend their overnight fast by abstaining from ingestion of energy-providing nutrients until 1200 each day, with all laboratory-based measurements followed-up 6 weeks later. Free-living assessments of energy intake (via direct weighed food diaries) and energy expenditure (via combined heart-rate/accelerometry) will be made during the first and last week of intervention, with continuous glucose monitors worn both to document chronic glycaemic responses to the intervention and to verify compliance.
authors: Human Physiology Research Group, Department for Health, University of Bath, UK.
authors: James A
authors: JA
authors: Betts
authors: Dylan
authors: D
authors: Thompson
authors: Judith D
authors: JD
authors: Richardson
authors: Enhad A
authors: EA
authors: Chowdhury
authors: Matthew
authors: M
authors: Jeans
authors: Geoffrey D
authors: GD
authors: Holman
authors: Kostas
authors: K
authors: Tsintzas
mesh_terms: D015502:Absorptiometry, Photon; D056044:Actigraphy / Q000295:instrumentation; D001786:Blood Glucose / Q000378:metabolism; D001823:Body Composition; D018592:Cross-Over Studies; D004435:Eating; D004734:Energy Metabolism; D004739:England; D005215:Fasting / Q000097:blood*; D005247:Feeding Behavior; D005260:Female; D005951:Glucose Tolerance Test; D006801:Humans; D007328:Insulin / Q000097:blood; D008297:Male; D019518:Postprandial Period; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D007328:Insulin