Gender Difference in Response to Caffeine in Children and Adolescents

Sex and Pubertal Stage Differences in Cardiovascular Responses to Caffeine in Children

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Low Caffeine Administration first (1mg/kg body weight); Drug: High Caffeine Administration first (2mg/kg body weight); Drug: Placebo Administration first

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14214
      • State University at New York at Buffalo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1mg/kg Caffeine; Order of Caffeine Administration for Visits 1-6: 1mg, 2mg, 0mg, 1mg, 2mg, 0mg	Drug: Low Caffeine Administration first (1mg/kg body weight); On two of the 6 visits, participants received a placebo (flattened sprite) added to their beverage. Order of Caffeine Administration for Visits 1-6: 1mg, 2mg, 0mg, 1mg, 2mg, 0mg
Experimental: 2mg/kg caffeine; Order of Caffeine Administration for Visits 1-6: 2mg, 0mg, 1mg, 2mg, 0mg, 1mg	Drug: High Caffeine Administration first (2mg/kg body weight); On two of the 6 visits, participants received a placebo (flattened sprite) added to their beverage. Order of Caffeine Administration for Visits 1-6: 2mg, 0mg, 1mg, 2mg, 0mg, 1mg
Experimental: Placebo; Order of Administration for Visits 1-6: 0mg, 1mg, 2mg, 0mg, 1mg, 2mg	Drug: Placebo Administration first; All participants received each dose on two days and the order of administration was counterbalanced. Order of Administration for Visits 1-6: 0mg, 1mg, 2mg, 0mg, 1mg, 2mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Heart Rate After 2 mg/kg 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.	Heart rate was collected every 10 minutes for 60 minutes after the dose of caffeine.
Peak Systolic Blood Pressure	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.	Blood pressure was assessed every 10 minutes for 60 minutes after caffeine was administered.

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Jennifer L Temple, PhD, SUNY Buffalo; Study Director: Amanda M Ziegler, MPH, SUNY Buffalo; Study Director: Adam M Graczyk, MS, SUNY Buffalo

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: April 14, 2014
• First Submitted That Met QC Criteria: April 18, 2014
• First Posted (Estimate): April 21, 2014

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: caffeine; healthy children; Cardiovascular influences
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: R01DA030386 (U.S. NIH Grant/Contract)