Gender Difference in Response to Caffeine in Children and Adolescents

Not Applicable

Completed

Conditions: Healthy

Interventions: Drug: High Caffeine Administration first (2mg/kg body weight)
Drug: Low Caffeine Administration first (1mg/kg body weight)
Drug: Placebo Administration first

Registration Number: NCT02119416

Lead Sponsor: State University of New York at Buffalo

Brief Summary: Caffeine use is on the rise in America, and one of the most popular sources is soda. Among youth ages 8-16, caffeine consumption has increased by over 70% in the past 30 years. Few studies have examined the role of hormones in caffeine consumption within this age group.

The purpose of the current experiment was to determine the effect of caffeine on children 8 and 9 compared to those 15 and 16 years of age. The investigators were looking at the effect of puberty on the consumption of caffeine as well as the effect that the caffeine has on the body (for example: heart rate, blood pressure) and cognitive function.

Detailed Description: Our previous studies have demonstrated sex differences in both the reinforcing properties of (Temple JL, Briatico LN, Clark EN, Dewey AM, 2009) and physiological responses to (Temple JL, Dewey AM, Briatico LN, 2010) caffeine. This is consistent with the literature on other types of drugs showing that men and women often differ in both drug self administration (Lynch WJ,2008 ) and drug sensitivity (Temple, JL, et al, 2008). These differences have been attributed, at least in part, to differences in gonadal hormones (Lynch WJ, 2008) ,Dreher JC et al, 2007). Our laboratory conducted a study investigating subjective effects of caffeine in post-pubertal adolescents and found that boys reported greater drug effects and liking of drug effects than did females (Temple JL, Dewey AM, Briatico LN, 2010, Temple JL, Ziegler AM,2011). In addition, the differences in feeling of the drug effects were related to salivary estradiol levels in females, but not in males, suggesting that steroid hormones can mediate the subjective effects of caffeine. When taken together, these data suggest that there are gender differences in acute and chronic effects of caffeine and that these differences may be mediated by differences in circulating steroid hormones. Previous studies have shown that subjective responses to caffeine vary across the menstrual cycle (Terner JM, de Wit H, 2006), with the greatest subjective effects occurring during the follicular phase, when estradiol levels begin to rise and peak just prior to the ovulatory LH surge. To date, no well-controlled studies have been conducted in humans examining the relationship between steroid hormones and caffeine effects on cognition, which the investigators will address in this study.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 101

Inclusion Criteria

males and females from 8-9 yoa or 15-17 yoa (post pubertal)
those 8-9 much have Tanner Staging below 3
those 15-17 much have Tanner Staging above 3.
willing to come into the lab 6 times for 1.5-2 hours each
those willing to abstain from consuming caffeine for 24 hours before each appointment
those willing to withdraw from consuming anything other than water for 2 hours before each appointment.
15-17 year old females much have begun menarche

Exclusion Criteria

those on ADHD medication or other's impacting caffeine metabolism
those reporting being on birth control or other hormones
those that are pregnant or breastfeeding
those outside the given age range or pubertal classification
those reporting having an adverse effect of caffeine in the past

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2mg/kg caffeine	High Caffeine Administration first (2mg/kg body weight)	Order of Caffeine Administration for Visits 1-6: 2mg, 0mg, 1mg, 2mg, 0mg, 1mg
1mg/kg Caffeine	Low Caffeine Administration first (1mg/kg body weight)	Order of Caffeine Administration for Visits 1-6: 1mg, 2mg, 0mg, 1mg, 2mg, 0mg
Placebo	Placebo Administration first	Order of Administration for Visits 1-6: 0mg, 1mg, 2mg, 0mg, 1mg, 2mg

Primary Outcome Measures

Name	Time	Method
Peak Heart Rate After 2 mg/kg of Caffeine	Heart rate was collected every 10 minutes for 60 minutes after the dose of caffeine.	Heart rate measurements were taken every 10 minutes, following 1 minute of rest with an automated Welch Allen Blood Pressure Cuff. We have reported the data as the peak heart rate after 2 mg/kg.
Peak Systolic Blood Pressure	Blood pressure was assessed every 10 minutes for 60 minutes after caffeine was administered.	Blood pressure measurements were taken every 10 minutes, following 1 minute of rest with an automated Welch Allen Blood Pressure Cuff. We have reported the peak heart rate after the 2 mg/kg dose of caffeine.

Secondary Outcome Measures