Condition category
Circulatory System
Date applied
11/07/2012
Date assigned
04/09/2012
Last edited
18/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
The aim of this study is to establish whether the amount in salt can be reduced in a common everyday food item such as bread without a discernible difference in taste. Bread has been chosen because of the fact that it is consumed in large quantities in the staple diet of many people in addition to the fact that it is also a large contributor to our daily salt intake.

Who can participate?
We have asked that only people over 18 participate and exclude anyone who is known to have Coeliac disease or is gluten intolerant. Both of the criteria have been passed by our local ethics committee.

What does the study involve?
The study involves members of the public tasting 5 different types of white bread. Each bread type will be made with varying levels of salt, a salt alternative such as Lo-Salt or no salt. All breads will be made by a professional local baker who adheres to local food standards for handling and preparation. The members of the public will then be asked to comment on the taste of the bread and record their views on a data sheet.

What are the possible benefits and risks of participating?
The benefits of reducing salt in bread are potentially huge. We generally consume far excess the amount of salt we actually need. High salt consumption has been linked to poor health outcomes such as stroke and cancer. By reducing salt in an everyday item such as bread, a significant knock on reduction on the overall amount of public salt consumption could be gained. There are very few risks.

Where is the study run from?
University of Oxford

When is study starting and how long is it expected to run for?
The study will run from August 2012 until December 2012. After this all the results collected will be subject to data analysis.

Who is funding the study?
National Institute of Health Research, National School of Primary Care Research.

Who is the main contact?
Dr Kamal R. Mahtani

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kamal Ram Mahtani

ORCID ID

Contact details

University of Oxford
Department of Primary Care Health Sciences
New Radcliffe House
Walton Street
Jericho
Oxford
OX2 6NW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

151

Study information

Scientific title

Can we reduce salt levels in bread without a discernable difference in taste

Acronym

Study hypothesis

Is there a difference in taste preference for bread made with half levels of salt or a salt alternative compared to standard levels of salt?

Ethics approval

Medical Sciences Interdisciplinary Research Ethics Committee, University of Oxford, 17/06/2012

Study design

Randomised controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Cardiovascular disease

Intervention

This is a double blinded randomised control cross over trial. Participants will be asked if they would like to taste some white bread then comment on it.
Participants will be recruited from the Oxfordshire general public.
Participants will be informed that this is a “bread tasting experiment”. Informed consent will be taken as the patient wishing to become enrolled and signing their participation sheet. They will be asked to taste 5 different types of white bread will be blinded to the salt content of the bread they will be tasting.
Their taste preference will be recorded on a Visual Analogue Scale which will be used for the analysis.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Overall taste score

Secondary outcome measures

Correlation between taste preference and:
1. Gender
2. Age
3. Smoking status

Overall trial start date

01/05/2012

Overall trial end date

01/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Adults (over 18 years of age) who regularly eat white bread

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

350

Participant exclusion criteria

Anyone under the age of 18 years old or has a gluten intolerance or Coeliac disease

Recruitment start date

01/05/2012

Recruitment end date

01/03/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Oxford
OX2 6NW
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

NIHR School for Primary Care Research
Primary Care Clinical Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

Government

Website

http://www.birmingham.ac.uk/schools/haps/departments/primarycare/index.aspx

Funders

Funder type

Government

Funder name

National Institute for Health Research - School for Primary Care Research (NSPCR) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes

18/03/2016: No publications found, verifying study status with principal investigator