Gender Difference in Response to Caffeine in Children and Adolescents

NCT ID: NCT02119416

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-10-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

1mg/kg Caffeine

Order of Caffeine Administration for Visits 1-6: 1mg, 2mg, 0mg, 1mg, 2mg, 0mg

Group Type: EXPERIMENTAL

Low Caffeine Administration first (1mg/kg body weight)

Intervention Type: DRUG

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

2mg/kg caffeine

Order of Caffeine Administration for Visits 1-6: 2mg, 0mg, 1mg, 2mg, 0mg, 1mg

Group Type: EXPERIMENTAL

High Caffeine Administration first (2mg/kg body weight)

Intervention Type: DRUG

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

Placebo

Order of Administration for Visits 1-6: 0mg, 1mg, 2mg, 0mg, 1mg, 2mg

Group Type: EXPERIMENTAL

Placebo Administration first

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Temple

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer L Temple, PhD

Role: PRINCIPAL_INVESTIGATOR

SUNY Buffalo

Amanda M Ziegler, MPH

Role: STUDY_DIRECTOR

SUNY Buffalo

Adam M Graczyk, MS

Role: STUDY_DIRECTOR

SUNY Buffalo

Locations

State University at New York at Buffalo

Buffalo, New York, United States

Countries

United States

Other Identifiers

R01DA030386

Identifier Type: NIH

Identifier Source: org_study_id

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