Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2010
Date assigned
03/11/2010
Last edited
15/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr James Betts

ORCID ID

Contact details

Department for Health
University of Bath
Claverton Down
Bath
BA2 7AY
United Kingdom
+44 (0)1225 383 448
J.Betts@bath.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BB/H008322/1

Study information

Scientific title

Extended daily fasting, regulation of energy balance and associated health outcomes: a randomised single centre intervention study with two phases

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

National Health Service (NHS) South West 3 Research Ethics Committee (REC), 13/04/2010, ref: 10/H0106/13. Amendment approved on 11/08/2010

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

Trial setting

Other

Trial type

Treatment

Patient information sheet

Can be found at http://www.bath.ac.uk/health/research/breakfastproject.html

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

14/04/2010

Overall trial end date

14/04/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

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

United Kingdom

Trial participating centre

University of Bath
Bath
BA2 7AY
United Kingdom

Sponsor information

Organisation

University of Bath (UK)

Sponsor details

c/o Dr James Betts
Human Physiology Research Group
Department for Health
Bath
BA2 7AY
United Kingdom
+44 (0)1225 383 448
j.betts@bath.ac.uk

Sponsor type

University/education

Website

http://www.bath.ac.uk/

Funders

Funder type

Research council

Funder name

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

Alternative name(s)

BBSRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21740575
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24898233
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26864365

Publication citations

  1. Protocol

    Betts JA, Thompson D, Richardson JD, Chowdhury EA, Jeans M, Holman GD, Tsintzas K, 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]., Trials, 2011, 12, 172, doi: 10.1186/1745-6215-12-172.

  2. Results

    Betts JA, Richardson JD, Chowdhury EA, Holman GD, Tsintzas K, Thompson D, The causal role of breakfast in energy balance and health: a randomized controlled trial in lean adults., Am. J. Clin. Nutr., 2014, 100, 2, 539-547, doi: 10.3945/ajcn.114.083402.

  3. Results

    EA Chowdhury, JD Richardson, GD Holman, K Tsintzas, D Thompson, JA Betts, The causal role of breakfast in energy balance and health: a randomized controlled trial in obese adults, Am J Clin Nutr, 2016, doi: 10.3945/​ajcn.115.122044.

Additional files

Editorial Notes

11/02/2016: Publication reference added.