Safety study to assess the effect of aspartame Nutritional, Metabolic, Endocrine
Conditions
Interventions
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
Sponsors
Hull and East Yorkshire Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed