Substantiation for Performance Claims

Hum Psychopharmacol. 2009 Apr;24(3):239-47. Effects of caffeine in chewing gum on mood and attention. Smith A.

RATIONALE: Recent research has shown that even small doses (<40mg) of caffeine can improve alertness and increase performance efficiency on attention tasks. Previous studies have given the caffeine in a variety of beverages or in capsules and it was of interest to see whether similar effects could be observed when the caffeine was given in gum. In addition, chewing gum has been shown to have behavioural effects and the present study extended our knowledge of this topic. OBJECTIVES: To compare the effects of caffeinated gum (40 mg), placebo gum and no gum conditions on mood and attention. METHODS: A double blind placebo controlled study was conducted with volunteers being randomly assigned to one of the three conditions. Baseline measures of mood and attention were taken prior to chewing and a test session was then conducted. One hundred and eighteen young adults participated in the study. RESULTS: Caffeinated gum was associated with a more positive mood and better performance on tasks requiring sustained attention. The caffeine improved the speed of encoding of new information which is consistent with previous findings. Chewing placebo gum was also found to be associated with more positive mood, both shortly after chewing and at the end of the study. CONCLUSIONS: The implications of the present study are that chewing caffeinated gum has been shown to improve performance efficiency and mood by its alerting and energizing effects. The profile of caffeine effects is what one would predict from the existing caffeine literature and such effects may be extremely beneficial in real-life situations. Prior chewing of placebo gum was associated with a more positive mood and this also confirms previous findings.

PMID: 19330801 [PubMed - indexed for MEDLINE]

Psychopharmacology (Berl). 2008 Oct;200(2):255-60. Epub 2008 Jun 9. Effects of caffeine on alertness as measured by infrared reflectance oculography.

Michael N, Johns M, Owen C, Patterson J.

RATIONALE: Caffeine is a well-known stimulant that can be used to increase alertness and performance especially in low arousal situations such as monotonous highway driving or after sleep deprivation. The effects of caffeine in rested, alert, participants are less clear, and this may be attributable to difficulties in objectively assessing small changes in alertness. OBJECTIVES: The present study examined the effects of caffeine in non-sleep-deprived participants with methods that have previously been shown to be sensitive to changes in alertness. In order to avoid confounding results, low, or non-users of caffeine, were sought as participants. MATERIALS AND METHODS: Twelve subjects participated in a within-subjects double-blind placebo-controlled design study and were administered either a capsule containing 200 mg of caffeine or placebo on two separate days. Ten-minute long tests of vigilance were performed at baseline and then at 30, 60, 120, 180, and 240 min after swallowing the capsule. During vigilance tests, eye blink variables were measured using infrared reflectance oculography and converted into a drowsiness score, Johns Drowsiness Scale (JDS). RESULTS: Caffeine significantly reduced JDS scores (drowsiness) and reaction times, and these changes persisted for 3 to 4 h. Self reports of sleepiness were not as sensitive, with Karolinska Sleepiness Scale scores only being significantly lower in the caffeine compared to placebo condition at 30 min post capsule administration. CONCLUSIONS: The results demonstrated that despite being well rested, administration of caffeine significantly increased alertness and enhanced performance, and these changes were able to be detected with the JDS. 

Substantiation for Healthy Claims

Please refer to  http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/ucm064916.htm