Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/08/2016
Date assigned
10/08/2016
Last edited
11/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
It is often said that breakfast is the most important meal of the day. However, the benefits of breakfast consumption have not been thoroughly investigated in well-designed studies. A recent study carried out in The University of Sheffield clearly showed that consuming a fortified cereal (cereal enriched with vitamins and minerals) with milk every day for 12 weeks led to an increase in the intake of vitamins and minerals and improved measures of nutritional status. The study was carried out in adolescent girls who rarely ate breakfast. Interestingly, if the cereal and milk was consumed for supper there was a small weight gain. This could not be explained by an increase in the amount of energy consumed. It is thought possible that taking cereal and milk as a breakfast might lead to an increase in the amount of energy used in physical activity (physical activity energy expenditure) later in the day, and that this is not seen when cereal with milk is taken as a supper. The aim of this study is to find out whether eating cereal with milk as breakfast will lead to an increase in physical activity energy expenditure compared with eating cereal with milk for supper.

Who can participate?
Healthy women aged 18-24 of normal weight who regularly skip breakfast

What does the study involve?
Participants are randomly allocated into two groups, who either eat cereal with milk for four days for breakfast or for supper. After a one week break, the two groups swap so that those who were eating the cereal for breakfast now eat it for dinner and vice versa. Participants are asked to wear an accelerometer (device to measure physical activity) on their wrist for all of their waking hours during the two four day study periods. Participants also complete a food diary for four days before and during the four day study periods. At the end of the study, energy expenditure is calculated from the accelerometer readings and dietary intakes are compared.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.

Where is the study run from?
The University of Sheffield (UK)

When is the study starting and how long is it expected to run for?
April 2007 to December 2015

Who is funding the study?
Kelloggs Company of Great Britain (UK)

Who is the main contact?
Professor Hilary Powers

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hilary Powers

ORCID ID

http://orcid.org/0000-0002-0496-5446

Contact details

Department of Oncology and Metabolism
The Medical School
The University of Sheffield
Sheffield
S102RX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

007629

Study information

Scientific title

A comparison of the effect of consuming cereal with milk as a breakfast or as a supper, on physical activity energy expenditure

Acronym

BEES

Study hypothesis

The consumption of cereal with milk as breakfast will elicit an increase in physical activity energy expenditure compared with consumption of cereal with milk as supper.

Ethics approval

University of Sheffield Research Ethics Committee, 12/02/2016, ref: 007629

Study design

Single-centre randomised crossover trial

Primary study design

Interventional

Secondary study design

Trial setting

Community

Trial type

Other

Patient information sheet

See additional files

Condition

Energy expenditure

Intervention

Participants are randomly allocated to eat 50g fortified breakfast cereal with 150ml semi-skimmed milk for breakfast or dinner for four days in a random order. There is a wash out period of one week between the two interventions.

Participants are asked to wear the Actigraph monitor for all their waking hours for each of the 4 day intervention periods. They are asked to take the monitor off when bathing or showering or swimming. They are asked not to wear the monitor when they go to bed.

Participants complete a food and beverage diary on three occasions - for 4 days prior to intervention and for 4 days for each of the interventions (i.e. cereal and milk at supper and at breakfast time). Participants are shown how much detail to put in the diaries and at the end of each 4-day period they meet with the researcher to discuss the details of their diary entries. They are asked to eat and drink what they liked, as long as they took their intervention cereal and milk. There is no follow-up. Data collection finishes when the last food diary has been completed and discussed.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Physical activity energy expenditure is measured using an accelerometer (Actigraph), worn on the wrist during waking hours of each 4 day intervention period.

Secondary outcome measures

Dietary intake is assessed using 4-day food and beverage diaries, facilitated by using food portion booklets.

Overall trial start date

09/05/2016

Overall trial end date

31/08/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female
2. Age 18-24 years
3. BMI between 18.5 and 25kg/m2
4. Report regularly skipping breakfast

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

20

Participant exclusion criteria

1. BMI outside 18.5-25 kg/m2 range
2. Report in training for sporting event
3. Known allergy to wheat, barley or milk

Recruitment start date

09/05/2016

Recruitment end date

31/08/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The University of Sheffield
Sheffield Medical School Beech Hill Road
Sheffield
S10 2RX
United Kingdom

Sponsor information

Organisation

The University of Sheffield

Sponsor details

The medical School
Beech Hill Road
Sheffield
S102RX
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Kelloggs Company of Great Britain

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Anticipated publishing a peer reviewed paper within 6 months of completion of the study. Potential target journals are: European Journal of Nutrition, British Journal of Nutrition, Public Health Nutrition.

Intention to publish date

31/12/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/08/2016: Uploaded participant information sheet.