Caffeine-Related DisordersNCT03292380
Validation of a 24-hour Caffeine Intake Recall
An observational study of Caffeine-Related Disorders, run by University of Waterloo at 1 site in Canada.
Trial summary
A 24-hour Caffeine Intake Recall (CIR-24) was developed to estimate caffeine consumption in the previous 24 hours, modeled after the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24), using a brand-specific database of caffeine-containing foods, beverages and supplements. Read more about this study
- Who is it for?
- Ages 17 to 30 years
- Conditions the study is for
- Caffeine-Related Disorders
- How many people
- 79 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jul 2015to 19 Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 17 to 30 years
- All sexes
- Child, Adult
Study population: A total of 85 young adults were recruited from a university community in southwestern Ontario from June to August, 2015. Recruitment strategies included distributing flyers to individuals on campus and in community settings, posting flyers in public areas, and making announcements to undergraduate classes using a consecutive sampling technique. We attempted to recruit an equal amount of individuals who self-reported consuming low, moderate, and high amounts of caffeinated beverages (within each sex); however, the caffeine consumption quotas were relaxed due to low response from high-intake consumers.
Who may be able to join
- 17-30 years of age
- read and speak English
- consumed at least some caffeine in a typical day
Who cannot join
- had smoked a cigarette in the past month
- pregnant
- taking oral contraceptives
Trial locations and contacts
1 site in 1 country.
Canada1 site
School of Public Health, University of Waterloo
Waterloo, Ontario, N2L3G1
About this study
Official title: Evaluation of a 24-hour Caffeine Intake Assessment Compared to Urinary Biomarkers of Caffeine Intake and a Brief Caffeinated Beverage Questionnaire
A 24-hour Caffeine Intake Recall (CIR-24) was developed to estimate caffeine consumption in the previous 24 hours, modeled after the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24), using a brand-specific database of caffeine-containing foods, beverages and supplements. The objective of this study was to evaluate the accuracy of the CIR-24 compared to caffeine concentration biomarkers in urine and a caffeinated beverage intake frequency screener (CBQ) among a young adult population.
79 young adults ages 18 to 29 years provided 24-hour urine samples and completed the CIR-24 and CBQ. Excretion rates for caffeine and eight caffeine metabolites were quantified from urine samples using high performance liquid chromatography-polarity switching electrospray ionization-tandem quadrupole mass spectrometry with stable isotope labeled internal standards.
Read the detailed description
The objective of this study was to evaluate the accuracy of the CIR-24 compared to caffeine concentration biomarkers in urine and a caffeinated beverage intake frequency screener (CBQ) among a young adult population.
A 24-hour Caffeine Intake Recall (CIR-24) was developed to estimate caffeine consumption in the previous 24 hours. The online, self-administered CIR-24 was developed to measure dietary intake of caffeine from food, beverages, and supplements. The tool was based on the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24), a web-based, self-administered tool for collecting dietary recalls and records. ASA24 uses a multiple-pass method adapted from the Automated Multiple-Pass Method (AMPM) used in NHANES in the US and the Canadian Community Health Survey in Canada. The same general question structure was used in this custom online survey, but the items queried were limited to foods, beverages and supplements that may contain caffeine. The tool was created for the Canadian context by listing only Canadian products, changing container sizes to reflect the Canadian marketplace, and including a French version. The food, beverage, and supplement categories and sub-categories can be found in Supplemental Table 1. Specific items listed were based on ASA24 and the Canadian Nutrient File, with additional items identified through the USDA National Nutrient Databases and internet searches. Respondents were asked about the consumption of items from each of four main categories (beverages, foods, energy products with added caffeine, and supplements) in the prior day. Based on each food or beverage reported, the participant receives tailored probes based on their responses, to identify the specific items that may have contained caffeine (e.g., if carbonated beverage consumption was reported, the participant is asked to specify the type of carbonated beverage and brand consumed). Amounts of each item consumed were ascertained based on the particular category: food amounts were estimated by the number of items/pieces consumed, or by a volume amount (depending on the item); beverage amounts were estimated using images of container types and sizes (adapted from the ASA24) (or volume for powders, liquids, and concentrates); and supplements were estimated by unit (or volume for powders and liquids). The CIR-24 tool is available at http://davidhammond.ca/wp-content/uploads/2015/11/2014-CED-Technical-Report.pdf.A database was compiled of the caffeine content of all food and beverage items in the Canadian Nutrient File listed as containing caffeine (with some additional items from the USDA National Nutrient Database for Standard Reference), plus energy drinks, shots, and products (sourced from the nutrition information on products purchased in previous studies, as well as internet searches), and supplements listed as containing caffeine in Health Canada's Licensed Natural Health Products Database (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/lnhpd-bdpsnh-eng.php) or identified through an online pharmacy (www.well.ca). More precise and brand-specific values were added for popular products such as coffee, using information provided by manufacturers (e.g., Starbucks, Tim Horton's, McDonald's) and/or websites that aggregate nutrition information (http://www.cspinet.org/new/cafchart.htm).
A paper version of a caffeinated beverage questionnaire (CBQ) from the Fred Hutchison Cancer Centre, adapted slightly for use in Canada (e.g., mL measures were included in addition to fluid ounces), was also administered.The CBQ included 13 beverage categories, including caffeinated and decaffeinated coffee (brewed and instant) and tea, energy drinks and highly caffeinated sodas, regular colas and root beer, and caffeine-free colas and root beer. Nine frequency categories were included: Never or less than once per month; 1-3 per month; 1 per week; 2-4 per week; 5-6 per week; 1 per day; 2-3 per day; 4-5 per day; 6+ per day. A reference for a 'medium' size for each type of beverage category was provided; respondents stated whether each drink size was small, medium or large in comparison to the reference amount. Responses to the CBQ were used to calculate average daily caffeine consumption for each respondent. First, the number of annual servings consumed for each questionnaire item was calculated by multiplying the reported frequency by the reported portion size. A 'small' size was multiplied by a serving ratio of 0.5, and a 'large' size was multiplied by 1.5. Next, the average annual volume of each beverage consumed was divided by 365 to estimate the daily intake of each beverage. The caffeine database that accompanies the tool was used to calculate the amount of caffeine consumed in milligrams. In cases in which frequency data for items were missing, we assumed that none was consumed, and when a frequency was entered but no portion size was indicated, the 'medium' size was assumed.
For each participant, all urine samples were combined, and the total volume of the entire 24-hour sample was recorded. A sample from each participant was aliquoted into a 2 mL cryovial, and immediately frozen at -80°C. Samples were moved for 8 days to a -20°C freezer due to logistical issues, and were later returned to -80°C. At the end of the study period, all samples were transported in insulated containers with dry ice to the CDC Nutritional Biomarkers Branch in Atlanta, GA for analysis.
Urine concentrations for caffeine (1,3,7-trimethylxanthine) and 8 caffeine metabolites (1,7-dimethylxanthine (Paraxanthine or 17X); 1,3-dimethylxanthine (theophylline, 13X); 1,3,7-trimethyluric acid (137U); 1,3-dimethyluric acid (13U); 1,7-dimethyluric acid (17U); 1-methyluric acid (1U); 1-methylxanthine (1X); and 5-acetylamino-6-amino-3-methyluracil (AAMU)) were quantified by use of a high performance liquid chromatography-polarity switching electrospray ionization-tandem quadrupole mass spectrometry with stable isotope labeled internal standards based on a method reported previously.(26) Existing studies indicate that these metabolites have moderate correlation with caffeine intake (14). The limits of detection were: 0.05 μmol/L for 1U; 0.01 μmol/L for theophylline; 0.02 μmol/L for 13U and 17U; 0.005 μmol/L 137U; 0.03 μmol/L for 1X; 0.003 mmol/L for caffeine; 0.006 μmol/L for 17X; and, 0.1 μmol/L for AAMU. Samples that had amounts below the limits of detection were excluded for that particular metabolite.
- Conditions
- Caffeine-Related Disorders
- Being tested
- No intervention was included
- Keywords
- Caffeine, Dietary intake, Validation, Dietary methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention was includedOther
| Study group | Role | What they receive |
|---|---|---|
| Caffeine intake recall | All subjects completed 24-hour urine collection, and subsequently completed the 24-hour Caffeine Intake Recall (CIR-24) developed by the research group and the Caffeinated Beverage Frequency Questionnaire (CBQ) developed by the Fred Hutchison Cancer Centre. The order of completing the CIR-24 and the CBQ was alternated each day of data collection. Receives: Other: No intervention was included |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour dietary intake from CIR-24
The amount of caffeine consumed in the previous 24 hours using the CIR-24 tool.
Measured: The day after the urine collection
Urine concentrations of caffeine and 8 additional metabolites
Urine concentrations for caffeine (1,3,7-trimethylxanthine) and 8 caffeine metabolites (1,7-dimethylxanthine (Paraxanthine or 17X); 1,3-dimethylxanthine (theophylline, 13X); 1,3,7-trimethyluric acid (137U); 1,3-dimethyluric acid (13U); 1,7-dimethyluric acid (17U); 1-methyluric acid (1U); 1-methylxanthine (1X); and 5-acetylamino-6-amino-3-methyluracil (AAMU)) were quantified by use of a high performance liquid chromatography-polarity switching electrospray ionization-tandem quadrupole mass spectrometry with stable isotope labeled internal standards based on a method reported previously. Existing studies indicate that these metabolites have moderate correlation with caffeine intake.
Urine samples were collected from the time participants woke the following day, for the subsequent 24-hour period. Participants were instructed to discard the first void of the 24-hour period, but to include the final void at the end of the 24-hour period (i.e., the next morning).
Measured: 24 hour collection, one day prior to self-report techniques
Secondary outcomes (1)
Daily caffeine intake according to CBQ
The average amount of caffeine consumed over one day using the CBQ
Measured: The previous 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start6 Jul 2015
- Primary completion19 Aug 2015
- Study completion19 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caffeine-Related DisordersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, David Hammond, University of Waterloo
- Investigators
- David Hammond, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292380
- Sponsor's protocol ID
- ORE File#20262
- Status last verified
- Sep 2017
- First submitted
- 19 Sep 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a 24-hour Caffeine Intake Assessment Compared to Urinary Biomarkers of Caffeine Intake and a Brief Caffeinated Beverage Questionnaire
- ClinicalTrials.gov ID
- NCT03292380
- Acronym / sponsor ID
- ORE File#20262
- Conditions
- Caffeine-Related Disorders
- Keywords
- Caffeine, Dietary intake, Validation, Dietary methods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Canadian Institutes of Health Research (CIHR)
- Study start
- 6 Jul 2015 (actual)
- Primary completion
- 19 Aug 2015 (actual)
- Study completion
- 19 Aug 2015 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 24-hour Caffeine Intake Recall (CIR-24) was developed to estimate caffeine consumption in the previous 24 hours, modeled after the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24), using a brand-specific database of caffeine-containing foods, beverages and supplements. The objective of this study was to evaluate the accuracy of the CIR-24 compared to caffeine concentration biomarkers in urine and a caffeinated beverage intake frequency screener (CBQ) among a young adult population.
79 young adults ages 18 to 29 years provided 24-hour urine samples and completed the CIR-24 and CBQ. Excretion rates for caffeine and eight caffeine metabolites were quantified from urine samples using high performance liquid chromatography-polarity switching electrospray ionization-tandem quadrupole mass spectrometry with stable isotope labeled internal standards.
Detailed description
The objective of this study was to evaluate the accuracy of the CIR-24 compared to caffeine concentration biomarkers in urine and a caffeinated beverage intake frequency screener (CBQ) among a young adult population.
A 24-hour Caffeine Intake Recall (CIR-24) was developed to estimate caffeine consumption in the previous 24 hours. The online, self-administered CIR-24 was developed to measure dietary intake of caffeine from food, beverages, and supplements. The tool was based on the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24), a web-based, self-administered tool for collecting dietary recalls and records. ASA24 uses a multiple-pass method adapted from the Automated Multiple-Pass Method (AMPM) used in NHANES in the US and the Canadian Community Health Survey in Canada. The same general question structure was used in this custom online survey, but the items queried were limited to foods, beverages and supplements that may contain caffeine. The tool was created for the Canadian context by listing only Canadian products, changing container sizes to reflect the Canadian marketplace, and including a French version. The food, beverage, and supplement categories and sub-categories can be found in Supplemental Table 1. Specific items listed were based on ASA24 and the Canadian Nutrient File, with additional items identified through the USDA National Nutrient Databases and internet searches. Respondents were asked about the consumption of items from each of four main categories (beverages, foods, energy products with added caffeine, and supplements) in the prior day. Based on each food or beverage reported, the participant receives tailored probes based on their responses, to identify the specific items that may have contained caffeine (e.g., if carbonated beverage consumption was reported, the participant is asked to specify the type of carbonated beverage and brand consumed). Amounts of each item consumed were ascertained based on the particular category: food amounts were estimated by the number of items/pieces consumed, or by a volume amount (depending on the item); beverage amounts were estimated using images of container types and sizes (adapted from the ASA24) (or volume for powders, liquids, and concentrates); and supplements were estimated by unit (or volume for powders and liquids). The CIR-24 tool is available at http://davidhammond.ca/wp-content/uploads/2015/11/2014-CED-Technical-Report.pdf.A database was compiled of the caffeine content of all food and beverage items in the Canadian Nutrient File listed as containing caffeine (with some additional items from the USDA National Nutrient Database for Standard Reference), plus energy drinks, shots, and products (sourced from the nutrition information on products purchased in previous studies, as well as internet searches), and supplements listed as containing caffeine in Health Canada's Licensed Natural Health Products Database (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/lnhpd-bdpsnh-eng.php) or identified through an online pharmacy (www.well.ca). More precise and brand-specific values were added for popular products such as coffee, using information provided by manufacturers (e.g., Starbucks, Tim Horton's, McDonald's) and/or websites that aggregate nutrition information (http://www.cspinet.org/new/cafchart.htm).
A paper version of a caffeinated beverage questionnaire (CBQ) from the Fred Hutchison Cancer Centre, adapted slightly for use in Canada (e.g., mL measures were included in addition to fluid ounces), was also administered.The CBQ included 13 beverage categories, including caffeinated and decaffeinated coffee (brewed and instant) and tea, energy drinks and highly caffeinated sodas, regular colas and root beer, and caffeine-free colas and root beer. Nine frequency categories were included: Never or less than once per month; 1-3 per month; 1 per week; 2-4 per week; 5-6 per week; 1 per day; 2-3 per day; 4-5 per day; 6+ per day. A reference for a 'medium' size for each type of beverage category was provided; respondents stated whether each drink size was small, medium or large in comparison to the reference amount. Responses to the CBQ were used to calculate average daily caffeine consumption for each respondent. First, the number of annual servings consumed for each questionnaire item was calculated by multiplying the reported frequency by the reported portion size. A 'small' size was multiplied by a serving ratio of 0.5, and a 'large' size was multiplied by 1.5. Next, the average annual volume of each beverage consumed was divided by 365 to estimate the daily intake of each beverage. The caffeine database that accompanies the tool was used to calculate the amount of caffeine consumed in milligrams. In cases in which frequency data for items were missing, we assumed that none was consumed, and when a frequency was entered but no portion size was indicated, the 'medium' size was assumed.
For each participant, all urine samples were combined, and the total volume of the entire 24-hour sample was recorded. A sample from each participant was aliquoted into a 2 mL cryovial, and immediately frozen at -80°C. Samples were moved for 8 days to a -20°C freezer due to logistical issues, and were later returned to -80°C. At the end of the study period, all samples were transported in insulated containers with dry ice to the CDC Nutritional Biomarkers Branch in Atlanta, GA for analysis.
Urine concentrations for caffeine (1,3,7-trimethylxanthine) and 8 caffeine metabolites (1,7-dimethylxanthine (Paraxanthine or 17X); 1,3-dimethylxanthine (theophylline, 13X); 1,3,7-trimethyluric acid (137U); 1,3-dimethyluric acid (13U); 1,7-dimethyluric acid (17U); 1-methyluric acid (1U); 1-methylxanthine (1X); and 5-acetylamino-6-amino-3-methyluracil (AAMU)) were quantified by use of a high performance liquid chromatography-polarity switching electrospray ionization-tandem quadrupole mass spectrometry with stable isotope labeled internal standards based on a method reported previously.(26) Existing studies indicate that these metabolites have moderate correlation with caffeine intake (14). The limits of detection were: 0.05 μmol/L for 1U; 0.01 μmol/L for theophylline; 0.02 μmol/L for 13U and 17U; 0.005 μmol/L 137U; 0.03 μmol/L for 1X; 0.003 mmol/L for caffeine; 0.006 μmol/L for 17X; and, 0.1 μmol/L for AAMU. Samples that had amounts below the limits of detection were excluded for that particular metabolite.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caffeine intake recall | – | Other: No intervention was includedAll subjects completed 24-hour urine collection, and subsequently completed the 24-hour Caffeine Intake Recall (CIR-24) developed by the research group and the Caffeinated Beverage Frequency Questionnaire (CBQ) developed by the Fred Hutchison Cancer Centre. The order of completing the CIR-24 and the CBQ was alternated each day of data collection. |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- A total of 85 young adults were recruited from a university community in southwestern Ontario from June to August, 2015. Recruitment strategies included distributing flyers to individuals on campus and in community settings, posting flyers in public areas, and making announcements to undergraduate classes using a consecutive sampling technique. We attempted to recruit an equal amount of individuals who self-reported consuming low, moderate, and high amounts of caffeinated beverages (within each sex); however, the caffeine consumption quotas were relaxed due to low response from high-intake consumers.
Key inclusion criteria (3 listed)
- 17-30 years of age
- read and speak English
- consumed at least some caffeine in a typical day
Key exclusion criteria (3 listed)
- had smoked a cigarette in the past month
- pregnant
- taking oral contraceptives
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 |
|---|---|---|
| No intervention was included | Other | Caffeine intake recall |
Primary outcome
24 hour dietary intake from CIR-24
Time frame: The day after the urine collection
The amount of caffeine consumed in the previous 24 hours using the CIR-24 tool.
Urine concentrations of caffeine and 8 additional metabolites
Time frame: 24 hour collection, one day prior to self-report techniques
Urine concentrations for caffeine (1,3,7-trimethylxanthine) and 8 caffeine metabolites (1,7-dimethylxanthine (Paraxanthine or 17X); 1,3-dimethylxanthine (theophylline, 13X); 1,3,7-trimethyluric acid (137U); 1,3-dimethyluric acid (13U); 1,7-dimethyluric acid (17U); 1-methyluric acid (1U); 1-methylxanthine (1X); and 5-acetylamino-6-amino-3-methyluracil (AAMU)) were quantified by use of a high performance liquid chromatography-polarity switching electrospray ionization-tandem quadrupole mass spectrometry with stable isotope labeled internal standards based on a method reported previously. Existing studies indicate that these metabolites have moderate correlation with caffeine intake. Urine samples were collected from the time participants woke the following day, for the subsequent 24-hour period. Participants were instructed to discard the first void of the 24-hour period, but to include the final void at the end of the 24-hour period (i.e., the next morning).
1 secondary outcome
Daily caffeine intake according to CBQ
Time frame: The previous 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Individual participant dataSharing planned: No
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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.
David Hammond, PhD principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caffeine-Related Disorders, run by University of Waterloo at 1 site in Canada.
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 3 inclusion and 3 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 25 Sep 2017. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
24 hour dietary intake from CIR-24 (time frame: The day after the urine collection). 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 25 Sep 2017.