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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1mg/kg Caffeine | Experimental | Order of Caffeine Administration for Visits 1-6: 1mg, 2mg, 0mg, 1mg, 2mg, 0mg |
|
| 2mg/kg caffeine | Experimental | Order of Caffeine Administration for Visits 1-6: 2mg, 0mg, 1mg, 2mg, 0mg, 1mg |
|
| Placebo | Experimental | Order of Administration for Visits 1-6: 0mg, 1mg, 2mg, 0mg, 1mg, 2mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer L Temple, PhD | SUNY Buffalo | Principal Investigator |
| Amanda M Ziegler, MPH | SUNY Buffalo | Study Director |
| Adam M Graczyk, MS | SUNY Buffalo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University at New York at Buffalo | Buffalo | New York | 14214 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1mg/kg Caffeine | Order of Caffeine Administration for Visits 1-6: 1mg/kg then 2mg/kg then 0mg/kg |
| FG001 | 2mg/kg Caffeine | Order of Caffeine Administration for Visits 1-6: 2mg/kg then 0mg/kg then 1mg/kg |
| FG002 | Placebo | Order of Administration for Visits 1-6: 0mg/kg then 1mg/kg then 2mg/kg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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all participants had all treatments across all studies on this project
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| ID | Title | Description |
|---|---|---|
| BG000 | 1mg/kg Caffeine | Order of Caffeine Administration for Visits 1-6: 1mg/kg then 2mg/kg then 0mg/kg |
| BG001 | 2mg/kg Caffeine | Order of Caffeine Administration for Visits 1-6: 2mg/kg then 0mg/kg then 1mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | beats per minute | Heart rate was collected every 10 minutes for 60 minutes after the dose of caffeine. |
|
We collected adverse events over the five year period covered by this funding proposal.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1mg/kg Caffeine | Order of Caffeine Administration for Visits 1-6: 1mg/kg then 2mg/kg then 0mg/kg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Temple | SUNYBuffalo | 716-829-5593 | jltemple@buffalo.edu |
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| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| 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 |
|
| BG002 | Placebo | Order of Administration for Visits 1-6: 0mg/kg then 1mg/kg then 2mg/kg |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| OG002 | 0 mg/kg Then 1 mg/kg Then 2 mg/kg | Order of Administration for Visits 1-6: 0mg/kg then 1mg/kg then 2mg/kg |
|
|
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| 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. | Participants were randomized to a particular order, but this was a crossover design. | Posted | Mean | Standard Error | mmHg | Blood pressure was assessed every 10 minutes for 60 minutes after caffeine was administered. |
|
|
|
|
| 0 |
| 96 |
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | 2mg/kg Caffeine | Order of Caffeine Administration for Visits 1-6: 2mg/kg then 0mg/kg then 1mg/kg | 0 | 96 | 0 | 96 | 0 | 96 |
| EG002 | Placebo | Order of Administration for Visits 1-6: 0mg/kg then 1mg/kg then 2mg/kg | 0 | 96 | 0 | 96 | 0 | 96 |
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| Mixed Models Analysis |
| <0.05 |
| Other |