Gender Difference in Response to Caffeine in Children and Adolescents

NCT02119416 | Completed Results

• 1 other identifier: R01DA030386
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Cardiovascular influences; caffeine; healthy children

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (3)

1mg/kg Caffeine

EXPERIMENTAL

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

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

2mg/kg caffeine

EXPERIMENTAL

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

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

Placebo

EXPERIMENTAL

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

Drug: Placebo Administration first

Interventions

Placebo Administration first 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

Placebo

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

1mg/kg Caffeine

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

2mg/kg caffeine

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• year old females much have begun menarche

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

State University at New York at Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Interventions

Weights and Measures

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Jennifer Temple
• Organization: SUNYBuffalo

jltemple@buffalo.edu

716-829-5593

Study Officials

• Jennifer L Temple, PhD

  SUNY Buffalo

  PRINCIPAL INVESTIGATOR

• Amanda M Ziegler, MPH

  SUNY Buffalo

  STUDY DIRECTOR

• Adam M Graczyk, MS

  SUNY Buffalo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 21, 2014
• Study Start: August 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: August 17, 2022
• Results First Posted: August 17, 2022

Record last verified: 2022-07

Locations

US (1)