Clinical trial NCT02119416: Gender Difference in Response to Caffeine in Children and Adolescents
Official title: Sex and Pubertal Stage Differences in Cardiovascular Responses to Caffeine in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Cardiovascular influences
caffeine
healthy children
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 101
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak Heart Rate After 2 mg/kg of Caffeine
timeFrame: Heart rate was collected every 10 minutes for 60 minutes after the dose of caffeine.
measure: Peak Systolic Blood Pressure
timeFrame: Blood pressure was assessed every 10 minutes for 60 minutes after caffeine was administered.
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: State University at New York at Buffalo
state: New York
Study officials:
affiliation: SUNY Buffalo
name: Jennifer L Temple, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: SUNY Buffalo
name: Amanda M Ziegler, MPH
role: STUDY_DIRECTOR
affiliation: SUNY Buffalo
name: Adam M Graczyk, MS
role: STUDY_DIRECTOR
References: