N/A
N=101
Gender Difference in Response to Caffeine in Children and Adolescents
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02119416 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Peak Heart Rate After 2 mg/kg of Caffeine — 73.6; 73.2; 79.6 beats per minute — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Placebo Administration first (Drug); Low Caffeine Administration first (1mg/kg body weight) (Drug); High Caffeine Administration first (2mg/kg body weight) (Drug)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Heart Rate After 2 mg/kg of Caffeine |
73.6; 73.2; 79.6 | <0.05 sig |
| PRIMARY Peak Systolic Blood Pressure |
107.6; 112.3; 109.6 | <0.05 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT02119416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.