title: Aspartame sensitivity? A double blind randomised crossover study.
abstract: BACKGROUND
  Aspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms. The objective of this study was to compare the acute symptom effects of aspartame to a control preparation.
  
  
  METHODS
  This was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight individual who has self reported sensitivity to aspartame were compared to 48 age and gender matched aspartame non-sensitive individuals. They were given aspartame (100mg)-containing or control snack bars randomly at least 7 days apart. The main outcome measures were acute effects of aspartame measured using repeated ratings of 14 symptoms, biochemistry and metabonomics.
  
  
  RESULTS
  Aspartame sensitive and non-sensitive participants differed psychologically at baseline in handling feelings and perceived stress. Sensitive participants had higher triglycerides (2.05 ± 1.44 vs. 1.26 ± 0.84mmol/L; p value 0.008) and lower HDL-C (1.16 ± 0.34 vs. 1.35 ± 0.54 mmol/L; p value 0.04), reflected in 1H NMR serum analysis that showed differences in the baseline lipid content between the two groups. Urine metabonomic studies showed no significant differences. None of the rated symptoms differed between aspartame and control bars, or between sensitive and control participants. However, aspartame sensitive participants rated more symptoms particularly in the first test session, whether this was placebo or control. Aspartame and control bars affected GLP-1, GIP, tyrosine and phenylalanine levels equally in both aspartame sensitive and non-sensitive subjects.
  
  
  CONCLUSIONS
  Using a comprehensive battery of psychological tests, biochemistry and state of the art metabonomics there was no evidence of any acute adverse responses to aspartame. This independent study gives reassurance to both regulatory bodies and the public that acute ingestion of aspartame does not have any detectable psychological or metabolic effects in humans.
  
  
  BACKGROUND
  ISRCTN Registry ISRCTN39650237.
authors.affiliation: Academic Endocrinology, Diabetes and Metabolism, Hull York Medical School, University of Hull, Hull, United Kingdom.
authors.forename: Thozhukat
authors.initials: T
authors.lastname: Sathyapalan
authors.affiliation: Food Standards Agency, London, United Kingdom.
authors.forename: Natalie J
authors.initials: NJ
authors.lastname: Thatcher
authors.affiliation: Department of Psychology, University of Hull, Hull, United Kingdom.
authors.forename: Richard
authors.initials: R
authors.lastname: Hammersley
authors.affiliation: Department of Academic Cardiology, University of Hull, Hull, United Kingdom.
authors.forename: Alan S
authors.initials: AS
authors.lastname: Rigby
authors.forename: Fraser L
authors.initials: FL
authors.lastname: Courts
authors.affiliation: Faculty of Medicine, Imperial College, London, United Kingdom.
authors.forename: Alexandros
authors.initials: A
authors.lastname: Pechlivanis
authors.affiliation: Faculty of Medicine, Imperial College, London, United Kingdom.
authors.forename: Nigel J
authors.initials: NJ
authors.lastname: Gooderham
authors.affiliation: Faculty of Medicine, Imperial College, London, United Kingdom.
authors.forename: Elaine
authors.initials: E
authors.lastname: Holmes
authors.affiliation: Diabetes Complications Research Centre, Conway Institute, University College Dublin, Belfield, Ireland.
authors.forename: Carel W
authors.initials: CW
authors.lastname: le Roux
authors.affiliation: Weill Cornell Medical College Qatar, Education City PO Box 24144, Doha, Qatar.
authors.forename: Stephen L
authors.initials: SL
authors.lastname: Atkin
mesh_terms: D000328:Adult; D000368:Aged; D001218:Aspartame / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013549:Sweetening Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D014280:Triglycerides / Q000097:blood
chemical_list: D013549:Sweetening Agents; D014280:Triglycerides; D001218:Aspartame