Healthy
Conditions
Keywords
Cardiovascular influences, caffeine, healthy children
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.
Interventions
DRUGPlacebo 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
DRUGLow 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
DRUGHigh 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
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Heart Rate After 2 mg/kg of Caffeine | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1mg/kg Caffeine Order of Caffeine Administration for Visits 1-6: 1mg/kg then 2mg/kg then 0mg/kg | 30 |
| 2mg/kg Caffeine Order of Caffeine Administration for Visits 1-6: 2mg/kg then 0mg/kg then 1mg/kg | 35 |
| Placebo Order of Administration for Visits 1-6: 0mg/kg then 1mg/kg then 2mg/kg | 31 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 | 1 |
| Overall Study | wrong pubertal stage | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | 2mg/kg Caffeine | Placebo | 1mg/kg Caffeine | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 35 Participants | 31 Participants | 30 Participants | 96 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12.2 years STANDARD_DEVIATION 1.1 | 12.2 years STANDARD_DEVIATION 1.1 | 12.2 years STANDARD_DEVIATION 1.1 | 12.2 years STANDARD_DEVIATION 1.1 |
| Region of Enrollment United States | 35 participants | 31 participants | 30 participants | 96 participants |
| Sex: Female, Male Female | 17 Participants | 14 Participants | 13 Participants | 44 Participants |
| Sex: Female, Male Male | 18 Participants | 17 Participants | 17 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 96 | 0 / 96 |
| other Total, other adverse events | 0 / 96 | 0 / 96 | 0 / 96 |
| serious Total, serious adverse events | 0 / 96 | 0 / 96 | 0 / 96 |
Outcome results
Primary
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.
Time frame: Heart rate was collected every 10 minutes for 60 minutes after the dose of caffeine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1mg/kg Caffeine Then 2 mg/kg Then 0 mg/kg | Peak Heart Rate After 2 mg/kg of Caffeine | 73.6 beats per minute | Standard Error 2.32 |
| 2mg/kg Caffeine Then 0 mg/kg Then 1 mg/kg | Peak Heart Rate After 2 mg/kg of Caffeine | 73.2 beats per minute | Standard Error 1.6 |
| 0 mg/kg Then 1 mg/kg Then 2 mg/kg | Peak Heart Rate After 2 mg/kg of Caffeine | 79.6 beats per minute | Standard Error 2.64 |
p-value: <0.05mixed effects regression
Comparison: We used repeated measures ANOVAS and conducted planned comparisons between groups as post-hoc tests.p-value: <0.05ANCOVA
Primary
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.
Time frame: Blood pressure was assessed every 10 minutes for 60 minutes after caffeine was administered.
Population: Participants were randomized to a particular order, but this was a crossover design.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1mg/kg Caffeine Then 2 mg/kg Then 0 mg/kg | Peak Systolic Blood Pressure | 107.6 mmHg | Standard Error 1.82 |
| 2mg/kg Caffeine Then 0 mg/kg Then 1 mg/kg | Peak Systolic Blood Pressure | 112.3 mmHg | Standard Error 1.69 |
| 0 mg/kg Then 1 mg/kg Then 2 mg/kg | Peak Systolic Blood Pressure | 109.6 mmHg | Standard Error 2.09 |
Comparison: order was included in the analysis. We examined caffeine dose.p-value: <0.05mixed effects regression
p-value: <0.05Mixed Models Analysis