Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/08/2012
Date assigned
11/10/2012
Last edited
09/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There is public concern over the safety of the artificial sweetener aspartame and the European Food Safety Authority has brought together an expert committee to review the evidence. The UK Food Standards Agency has suggested a small study to look at the concerns of the public on the symptoms caused by aspartame. In this study we will use questionnaires and laboratory tests to determine whether the perceived effects of aspartame can be detected in people who say they have a problem eating aspartame, compared with people who consume aspartame with no problem.

Who can participate?
People who say they have a problem eating aspartame and people who normally consume foods containing aspartame with no problem.

What does the study involve?
Participants are asked to eat a snack bar containing aspartame and a matched bar containing no aspartame at two visits one week apart. The dose of aspartame is well below the maximum recommended level.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
University of Hull and Hull Royal Infirmary Hospital (UK).

When is the study starting and how long is it expected to run for?
February 2010 to August 2012.

Who is funding the study?
Food Standard Agency (UK).

Who is the main contact?
Professor Stephen Atkin
stephen.atkin@hyms.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephen Atkin

ORCID ID

Contact details

Hull York Medical School
Michael White Centre for Diabetes
Endocrinology & Metabolism
Brocklehurst Building
Hull Royal Infirmary
220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom
+44 (0)1482 675312
stephen.atkin@hyms.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1.5

Study information

Scientific title

Determination of the symptoms of aspartame in subjects who have reported symptoms in the past compared to controls: a pilot double blind placebo-controlled study

Acronym

Study hypothesis

To assess the efficacy of the necessary psychometric and biochemical methodologies to determine whether the perceived effects of aspartame can be detected in sufferers compared to non sufferers

Ethics approval

East Yorkshire & North Lincolnshire Research Ethics Committee, 30/06/2009, ref: 09/H1304/46

Study design

Double-blinded placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

Safety study to assess the effect of aspartame

Intervention

75 self reported responders to aspartame and 75 normal control participants

The snack bar is to be eaten by fasting participants; they will be asked to eat 2 bars given in a double blinded and randomized order, one containing aspartame and one is aspartame free. These bars will be given to the subject one week apart. The dose of aspartame in the bar is 100mg, this is well below the Reference Daily Intake maximum recommended by EFSA of 40mg/kg bw.

Visit 1 - Full blood count (FBC), biochemical profile
Visit 2 & 3 - Insulin, Glucose, Glucagon-like peptide-1 (GLP-1), Gastric inhibitory polypeptide (GIP), biochemical profile and glucose, glucagons, Interleukins, TNF alpha and IgE, Aspartame

Intervention type

Other

Phase

Drug names

Primary outcome measures

Testing of the rigour of the study methods and design. To determine the power needed for a large scale study for the investigation of subjects with self diagnosed adverse reactions to aspartame.

Secondary outcome measures

1. To validate that the product used for the trial is optimal and fit for purpose
2. To ascertain the optimal design for the main study
3. To validate the questionnaire tools for the identification of symptoms of adverse events in individuals reporting self diagnosed adverse reactions
4. To validate the biochemical assays in individuals reporting self diagnosed adverse reaction

Overall trial start date

12/02/2010

Overall trial end date

30/08/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy volunteers:
1. No known allergies
2. No concomitant medical condition
3. No medication

Aspartame reactors:
1. Reported effect of aspartame on ingestion
2. No allergies to other food substances

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

150 (75 normal control / 75 aspartame sensitive)

Participant exclusion criteria

1. Allergies to food or medication
2. A concomitant medical condition
3. Prescription medication
4. Refusal for GP to be informed

Aspartame reactors:
1. Allergies to food or medication
2. A concomitant medical condition
3. Prescription medication
4. Refusal for GP to be informed

Recruitment start date

12/02/2010

Recruitment end date

30/08/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hull York Medical School
Hull
HU3 2RW
United Kingdom

Sponsor information

Organisation

Hull and East Yorkshire Hospitals NHS Trust (UK)

Sponsor details

Research & Development Department
2nd Floor
Daisy Building
Castle Hill Hospital
Castle Road
Cottingham
Hull
HU16 5JQ
United Kingdom
+44 (0)1482 461903
james.illingworth@hey.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Food Standards Agency

Alternative name(s)

FSA

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25786106

Publication citations

Additional files

Editorial Notes