HealthyNCT02119416
Gender Difference in Response to Caffeine in Children and Adolescents
A study testing Low Caffeine Administration first (1mg/kg body weight) and High Caffeine Administration first (2mg/kg body weight) in people with Healthy, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Low Caffeine Administration first (1mg/kg body weight) and High Caffeine Administration first (2mg/kg body weight)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
State University at New York at Buffalo
Buffalo, New York, 14214
About this study
Official title: 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.
Read the 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
- Being tested
- Placebo Administration first, Low Caffeine Administration first (1mg/kg body weight), High Caffeine Administration first (2mg/kg body weight)
- Keywords
- Cardiovascular influences, caffeine, healthy children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Administration firstDrug
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
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
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
| Study group | Role | What they receive |
|---|---|---|
| 1mg/kg Caffeine | Experimental | Order of Caffeine Administration for Visits 1-6: 1mg, 2mg, 0mg, 1mg, 2mg, 0mg Receives: 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 Receives: Drug: High Caffeine Administration first (2mg/kg body weight) |
| Placebo | Experimental | Order of Administration for Visits 1-6: 0mg, 1mg, 2mg, 0mg, 1mg, 2mg Receives: Drug: Placebo Administration first |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Blood pressure was assessed every 10 minutes for 60 minutes after caffeine was administered.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startAug 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Temple, State University of New York at Buffalo
- Investigators
- Jennifer L Temple, PhD, Principal investigator, SUNY BuffaloAmanda M Ziegler, MPH, Study director, SUNY BuffaloAdam M Graczyk, MS, Study director, SUNY Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119416
- Sponsor's protocol ID
- R01DA030386
- Status last verified
- Jul 2022
- First submitted
- 14 Apr 2014
- Last updated
- 17 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex and Pubertal Stage Differences in Cardiovascular Responses to Caffeine in Children
- ClinicalTrials.gov ID
- NCT02119416
- Acronym / sponsor ID
- R01DA030386
- Conditions
- Healthy
- Keywords
- Cardiovascular influences, caffeine, healthy children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Posted 17 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1mg/kg Caffeine | Experimental | Drug: Low Caffeine Administration first (1mg/kg body weight)Order of Caffeine Administration for Visits 1-6: 1mg, 2mg, 0mg, 1mg, 2mg, 0mg |
| 2mg/kg caffeine | Experimental | Drug: High Caffeine Administration first (2mg/kg body weight)Order of Caffeine Administration for Visits 1-6: 2mg, 0mg, 1mg, 2mg, 0mg, 1mg |
| Placebo | Experimental | Drug: Placebo Administration firstOrder of Administration for Visits 1-6: 0mg, 1mg, 2mg, 0mg, 1mg, 2mg |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Administration firstAll 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 | Drug | Placebo |
| 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 | Drug | 1mg/kg Caffeine |
| 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 | Drug | 2mg/kg caffeine |
Primary outcome
Peak Heart Rate After 2 mg/kg of Caffeine
Time frame: Heart rate was collected every 10 minutes for 60 minutes after the dose 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.
Peak Systolic Blood Pressure
Time frame: Blood pressure was assessed every 10 minutes for 60 minutes after caffeine was administered.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Temple, PhD principal investigator
SUNY Buffalo
Amanda M Ziegler, MPH study director
SUNY Buffalo
Adam M Graczyk, MS study director
SUNY Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Caffeine Administration first (1mg/kg body weight) and High Caffeine Administration first (2mg/kg body weight) in people with Healthy, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Heart Rate After 2 mg/kg of Caffeine (time frame: Heart rate was collected every 10 minutes for 60 minutes after the dose of caffeine.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.