Aspartame study: Determination of the symptoms of aspartame in subjects who have reported symptoms in the past compared to controls
| ISRCTN | ISRCTN39650237 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39650237 |
| Secondary identifying numbers | Version 1.5 |
- Submission date
- 10/08/2012
- Registration date
- 11/10/2012
- Last edited
- 09/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Scientific
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
| Phone | +44 (0)1482 675312 |
|---|---|
| stephen.atkin@hyms.ac.uk |
Study information
| Study design | Double-blinded placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| 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(s) | East Yorkshire & North Lincolnshire Research Ethics Committee, 30/06/2009, ref: 09/H1304/46 |
| 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 |
| Primary outcome measure | 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 study start date | 12/02/2010 |
| Overall study end date | 30/08/2012 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 (75 normal control / 75 aspartame sensitive) |
| 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 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
- England
- United Kingdom
Study participating centre
HU3 2RW
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Development Department
2nd Floor, Daisy Building
Castle Hill Hospital
Castle Road
Cottingham
Hull
HU16 5JQ
England
United Kingdom
| Phone | +44 (0)1482 461903 |
|---|---|
| james.illingworth@hey.nhs.uk | |
"ROR" |
https://ror.org/01b11x021 |
Funders
Funder type
Government
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Food Standards Agency, FSA
- 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? |
|---|---|---|---|---|---|
| Results article | results | 18/03/2015 | Yes | No |
