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Gender Difference in Response to Caffeine in Children and Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02119416
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
State University of New York at Buffalo

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Placebo Administration first Drug: Low Caffeine Administration first (1mg/kg body weight) Drug: High Caffeine Administration first (2mg/kg body weight) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Sex and Pubertal Stage Differences in Cardiovascular Responses to Caffeine in Children
Study Start Date : August 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

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





Primary Outcome Measures :
  1. Change in Heart Rate [ Time Frame: 0,10, 20, 30, 40, 50, 60 min ]

    Heart rate measurements were taken every 10 minutes, following 1 minute of rest with an automated Welch Allen Blood Pressure Cuff.

    This procedure was duplicated on all 6 visits.


  2. Change in Blood pressure [ Time Frame: 0, 10, 20, 30, 40, 50, 60min ]

    Blood pressure measurements were taken every 10 minutes, following 1 minute of rest with an automated Welch Allen Blood Pressure Cuff.

    This procedure was duplicated on all 6 visits.




Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119416


Locations
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United States, New York
State University at New York - at Buffalo, NY
Buffalo, New York, United States, 14214
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
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Principal Investigator: Jennifer L Temple, PhD SUNY Buffalo
Study Director: Amanda M Ziegler, MPH SUNY Buffalo
Study Director: Adam M Graczyk, MS SUNY Buffalo

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Responsible Party: State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT02119416    
Other Study ID Numbers: R01DA030386 ( U.S. NIH Grant/Contract )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: April 2014
Keywords provided by State University of New York at Buffalo:
Cardiovascular influences
caffeine
healthy children
Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents