Extended daily fasting (omission of breakfast) and regulation of energy balance

ISRCTN	ISRCTN31521726
DOI	https://doi.org/10.1186/ISRCTN31521726
Secondary identifying numbers	BB/H008322/1

Submission date: 30/09/2010
Registration date: 03/11/2010
Last edited: 12/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr James Betts
Scientific

Department for Health
University of Bath
Claverton Down
Bath
BA2 7AY
United Kingdom

Phone	+44 (0)1225 383 448
Email	J.Betts@bath.ac.uk

Study information

Study design	Interventional single-centre randomised study: phase I = cross-over, phase II = parallel group
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Can be found at http://www.bath.ac.uk/health/research/breakfastproject.html
Scientific title	Extended daily fasting, regulation of energy balance and associated health outcomes: a randomised single centre intervention study with two phases
Study acronym	Bath Breakfast Project (BBP)
Study hypothesis	Primary hypothesis: Extended daily fasting will cause a positive shift in energy balance relative to frequent breakfast consumption due to decreased spontaneous physical activity. Secondary hypothesis: Extended daily fasting will cause a change in energy balance regulatory hormones conducive of increased appetite and decreased spontaneous physical activity relative to frequent breakfast consumption, with a resultant impairment of glycaemic control and increased systemic inflammation.
Ethics approval(s)	National Health Service (NHS) South West 3 Research Ethics Committee (REC), 13/04/2010, ref: 10/H0106/13. Amendment approved on 11/08/2010
Condition	Diet/inactivity/obesity-related diabetes and associated cardiovascular disease
Intervention	Intervention: 6-week daily consumption of breakfast (i.e. at least 2933 kJ before 11:00) Control: 6-week daily omission of breakfast (i.e. 0 kJ until 12:00)
Intervention type	Other
Primary outcome measure	Alterations in energy balance between treatments (i.e. the culmination of resting metabolic rate, diet-induced thermogenesis and physical activity energy expenditure relative to dietary energy intake). All measurements contributing to both the primary and secondary outcomes are made throughout two 8 hour lab visits during Phase I and then continuously throughout the first and sixth week of dietary intervention during Phase II.
Secondary outcome measures	Both the mechanistic data explaining how the intervention may have impacted on energy balance (i.e. appetite regulatory hormones, metabolic regulatory hormones and associated expression of key genes) and also the whole-body endpoints indicative of altered health status with each treatment (i.e. adiposity, glycaemic control and chronic lowgrade inflammation). All measurements contributing to both the primary and secondary outcomes are made throughout two 8 hour lab visits during Phase I and then continuously throughout the first and sixth week of dietary intervention during Phase II.
Overall study start date	14/04/2010
Overall study end date	14/04/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	70
Participant inclusion criteria	1. Participants may be male or female (females may or may not be taking oral contraceptives but must maintain a record of menstrual cycle phase or contraceptive use prior to entry into the study) 2. Those within the specified age range (20 - 60 years) 3. Individuals with a body mass index between 20 - 24 kg/m2 or above 30 kg/m2 4. Able and willing to safely comply with all study procedures 5. Able to provide written informed consent for participation whilst acknowledging their freedom to withdraw at any point during the study
Participant exclusion criteria	1. Women who are known to be pregnant or who are intending to become pregnant over the course of the study 2. Women who are breast feeding 3. Participation in another clinical trial 4. Any reported use of substances which may pose undue personal risk to participants or introduce bias into the experiment 5. Any other condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias into the experiment 6. Individuals with any known bleeding disorder 7. Individuals currently taking any medication known to act as an anticoagulant
Recruitment start date	14/04/2010
Recruitment end date	14/04/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Bath

Bath
BA2 7AY
United Kingdom

Sponsor information

University of Bath (UK)
University/education

c/o Dr James Betts
Human Physiology Research Group
Department for Health
Bath
BA2 7AY
England
United Kingdom

Phone	+44 (0)1225 383 448
Email	j.betts@bath.ac.uk
Website	http://www.bath.ac.uk/
"ROR"	https://ror.org/002h8g185

Funders

Funder type

Research council

Biotechnology and Biological Sciences Research Council (BBSRC) (UK) (ref: BB/H008322/1)
Government organisation / National government

Alternative name(s): UKRI - Biotechnology And Biological Sciences Research Council, BBSRC UK, BBSRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	08/07/2011		Yes	No
Results article	results	01/08/2014		Yes	No
Results article	results	01/03/2016		Yes	No
Results article	results	01/01/2018		Yes	No
Results article	substudy results	01/05/2019	12/03/2020	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

12/03/2020: Publication reference added.
14/02/2018: Publication reference added.
11/02/2016: Publication reference added.