Determining reactions to aspartame in subjects who have reported symptoms in the past compared to controls

Last updated:
17 February 2010
Study Duration: July 2009 to November 2014
Contractor: University of Hull
Project Code: FS231010 (T01054)

Background

A number of individuals report adverse reactions after consuming food and drink containing aspartame. Whilst numerous research studies and risk assessments have shown aspartame can be consumed safely, individual reports of these reactions persist. Given this continuing anecdotal evidence, European regulatory authorities, including the Food Standards Agency, feel it’s appropriate to see if more can be found out about these alleged effects. This pilot study aims to determine the feasibility and power required for an effective full scale study to address the concerns of the public.

Research Approach

This double blind placebo controlled pilot study aims to record any effects from eating a snack bar that may or may not contain aspartame, in a safe controlled clinical environment. The study will recruit fifty individuals who report reactions, including (but not exclusively) headaches and nausea, after consuming aspartame and fifty individuals who normally consume foods containing aspartame without problems to act as controls.

Subjects will be asked to complete general health and wellbeing questionnaires, they will also provide blood and urine samples. The samples will be analysed to determine the effect of aspartame consumption on plasma and urinary metabolite profile. The data will be assessed to determine the suitability of the product and the methodology in order to determine the feasibility and power required for an effective full scale study.