NutritionNCT03512496
Metabolic and Genetic Impacts of Energy Drinks in Youth
A study testing Acute energy drink - Caffein and Acute energy drink - Decaf in people with Nutrition and Pediatric Obesity, run by University of Calgary at 1 site in Canada.
Trial summary
Caffeine containing energy drinks (CCED) are beverages that typically contain mixtures of simple sugars, caffeine and may contain vitamin, mineral and/or herbal preparations. In Canada, the consumption of CCEDs among adolescents is a regular occurrence and a common part of the everyday diet. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Pediatric Obesity, Pediatric
- What is being tested?
- Acute energy drink - Caffein and Acute energy drink - Decaf
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2014to 1 Jun 2015
- Phase
- Interventional
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male and female: Current data indicates no hormonal (menstrual cycle) or sex influence on caffeine pharmacokinetics or caffeine-induced insulin resistance.
- Aged 13-19: This age group has been shown to be key consumers of caffeinated energy drinks, and this study is specifically looking at the effects of these beverages in those of adolescent age.
- Lean and Obese: Individuals will be listed as obese if their Body Mass Index is greater or equal to the 85th percentile.
Who cannot join
- Participants will be excluded if they have underlying medical conditions affecting glucose tolerance, for example, inhaled steroid use, pancreatitis, diabetes, glucose intolerance etc. Any underlying condition affecting glucose tolerance would negatively skew results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Metabolic and Genetic Impacts of Acute Energy Drink Consumption in Youth
Caffeine containing energy drinks (CCED) are beverages that typically contain mixtures of simple sugars, caffeine and may contain vitamin, mineral and/or herbal preparations. In Canada, the consumption of CCEDs among adolescents is a regular occurrence and a common part of the everyday diet. Contributing to the obesity epidemic in youth is the consumption of energy drinks; yet no data on the metabolic responses to CCEDs exists. This study will examine the metabolic implications of CCED consumption in adolescents, aged 13-19 years. The investigators hypothesize that CCEDs will impair glucose tolerance by ~30% in lean adolescents and the primary cause of the insulin resistance will be caffeine. Obese individuals will experience a similar level of glucose impairment, but a greater rise in blood glucose compared to their lean counterparts (i.e. higher starting glucose level). For many, this additional, caffeine-induced rise will expose them to hyperglycemia, putting some individuals in the glucose intolerant or transient diabetic range. It is hypothesized that continued metabolic insult resulting from CCEDs may predispose susceptible individuals to chronic metabolic diseases later in life. The investigators will also examine the genetic basis of caffeine-induced glucose intolerance. This gene-diet interaction could explain why caffeine may be much more metabolically harmful for some individuals compared to others. The study of 'metabolomics' will also be utilized to analyze caffeine and caffeine metabolites such as theobromine, theophylline, and xanthine. This will be accomplished using Nuclear Magnetic Resonance (NMR) spectroscopy. Results from this study will have the potential to alter current perceptions that CCED are 'harmless' and will have far reaching implications for both medical professionals and legislators alike.
Read the detailed description
This study will recruit male and female adolescents (aged 13-19y). Eligible participants will be booked for an initial visit where parental consent (where necessary ie. under 18 years of age) will be obtained; individuals will then be screened for overall health status. Self-report questionnaires will be administered to participants and will include information on stage of physical development (Tanner Staging), medical history, ethnicity, caffeine use (including CCEDs), gaming, physical activity and smoking status (iPad based). In the second, third and fourth visits, subjects will arrive following a 24-48h abstention from caffeine, alcohol and vigorous exercise and an overnight fast (8h). Participants will undergo three modified oral glucose tolerance tests (OGTT), following administration of either a water placebo (control), a caffeine-free CCED (control) or a caffeine containing CCED (5mg/kg caffeine) in a randomly assigned, double-blind, crossover design. Briefly, subjects will arrive and a baseline blood sample will be obtained (numbing cream will be offered). This will be immediately followed by administration of the treatment. Following a 30min absorption period, a standard OGTT (75g Trutol) will be administered. Additional blood samples will be obtained at 0, 30, 45, 60, 90, and 120min and assessed for glucose, insulin, fatty acids and C-peptide employing standard chemistry procedures. A peripheral IV will be used to obtain the 7 samples reducing needle pokes to one, ideally. Trials will be separated by at least 1wk, but not more than 4wk. Blood samples collected during the OGTT (all time points) will be assessed for metabolic and satiety signally hormone responses (ie. insulin). All subjects will also be asked to provide a saliva sample for genetic analysis. Genetic analysis will be performed by the company 23 \& Me. Subjects will also be asked to provide a midstream urine sample 30 minutes prior to the completion of the OGTT (90min time point +/10 mins). This is to allow for the analysis of caffeine and caffeine metabolites present in the urine, which will give insight into how caffeine is metabolized and excreted differently among individuals.
- Conditions
- Nutrition, Pediatric Obesity, Pediatric, Caffeine, Metabolism Disorder, Glucose, Health Behavior
- Being tested
- Acute energy drink - Placebo, Acute energy drink - Caffein, Acute energy drink - Decaf
- Keywords
- Energy Drink, Pediatric, Metabolism, Glucose, Caffeine, Obesity, Nutrition, Metabolomics, Health Behavior, Glucose Intolerance
- Medical subject headings
- Pediatric Obesity, Glucose Metabolism Disorders, Health Behavior, Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute energy drink - PlaceboDietary supplement
Colored water
Acute energy drink - CaffeinDietary supplement
Sugar free energy drink at 5mg/kg caffeine
Acute energy drink - DecafDietary supplement
Sugar free decaf energy drink (vitamins only)
| Study group | Role | What they receive |
|---|---|---|
| Acute energy drink - Control | Placebo comparator | Coloured Water was given 40 min prior to the OGTT test. Receives: Dietary Supplement: Acute energy drink - Placebo |
| Acute energy drink - Caffeine | Active comparator | Sugar Free energy drink at 5mg/kg caffeine was given 40 min prior to OGTT test. Receives: Dietary Supplement: Acute energy drink - Caffein |
| Acute energy drink- Decaf | Sham comparator | Sugar free decaf energy drink (vitamins only) was given 40 min prior to OGTT test. Amount of drink was same as that of Caffeine Receives: Dietary Supplement: Acute energy drink - Decaf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance
Participants will undergo an oral glucose tolerance test(OGTT), following administration of either a water placebo(control), a caffeine-free CCED or a caffeine-containing CCED.
Measured: 120 min
Secondary outcomes (1)
Metabolomics
Metabolomics will be assessed in serum collected at all time points of OGTT to analyze metabolic responses.
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start1 Dec 2014
- Primary completion1 Jun 2015
- Study completion1 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Model description
- Randomized, double blind, crossover design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512496
- Sponsor's protocol ID
- REB14-1093
- Status last verified
- Apr 2018
- First submitted
- 5 Apr 2018
- Last updated
- 7 Nov 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Metabolic and Genetic Impacts of Acute Energy Drink Consumption in Youth
- ClinicalTrials.gov ID
- NCT03512496
- Acronym / sponsor ID
- REB14-1093
- Conditions
- Nutrition, Pediatric Obesity, Pediatric, Caffeine, Metabolism Disorder, Glucose, Health Behavior
- Keywords
- Energy Drink, Pediatric, Metabolism, Glucose, Caffeine, Obesity, Nutrition, Metabolomics
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 1 Jun 2015 (actual)
- Study completion
- 1 Jun 2015 (actual)
- First posted
- 30 Apr 2018 (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.
Caffeine containing energy drinks (CCED) are beverages that typically contain mixtures of simple sugars, caffeine and may contain vitamin, mineral and/or herbal preparations. In Canada, the consumption of CCEDs among adolescents is a regular occurrence and a common part of the everyday diet. Contributing to the obesity epidemic in youth is the consumption of energy drinks; yet no data on the metabolic responses to CCEDs exists. This study will examine the metabolic implications of CCED consumption in adolescents, aged 13-19 years. The investigators hypothesize that CCEDs will impair glucose tolerance by ~30% in lean adolescents and the primary cause of the insulin resistance will be caffeine. Obese individuals will experience a similar level of glucose impairment, but a greater rise in blood glucose compared to their lean counterparts (i.e. higher starting glucose level). For many, this additional, caffeine-induced rise will expose them to hyperglycemia, putting some individuals in the glucose intolerant or transient diabetic range. It is hypothesized that continued metabolic insult resulting from CCEDs may predispose susceptible individuals to chronic metabolic diseases later in life. The investigators will also examine the genetic basis of caffeine-induced glucose intolerance. This gene-diet interaction could explain why caffeine may be much more metabolically harmful for some individuals compared to others. The study of 'metabolomics' will also be utilized to analyze caffeine and caffeine metabolites such as theobromine, theophylline, and xanthine. This will be accomplished using Nuclear Magnetic Resonance (NMR) spectroscopy. Results from this study will have the potential to alter current perceptions that CCED are 'harmless' and will have far reaching implications for both medical professionals and legislators alike.
Detailed description
This study will recruit male and female adolescents (aged 13-19y). Eligible participants will be booked for an initial visit where parental consent (where necessary ie. under 18 years of age) will be obtained; individuals will then be screened for overall health status. Self-report questionnaires will be administered to participants and will include information on stage of physical development (Tanner Staging), medical history, ethnicity, caffeine use (including CCEDs), gaming, physical activity and smoking status (iPad based). In the second, third and fourth visits, subjects will arrive following a 24-48h abstention from caffeine, alcohol and vigorous exercise and an overnight fast (8h). Participants will undergo three modified oral glucose tolerance tests (OGTT), following administration of either a water placebo (control), a caffeine-free CCED (control) or a caffeine containing CCED (5mg/kg caffeine) in a randomly assigned, double-blind, crossover design. Briefly, subjects will arrive and a baseline blood sample will be obtained (numbing cream will be offered). This will be immediately followed by administration of the treatment. Following a 30min absorption period, a standard OGTT (75g Trutol) will be administered. Additional blood samples will be obtained at 0, 30, 45, 60, 90, and 120min and assessed for glucose, insulin, fatty acids and C-peptide employing standard chemistry procedures. A peripheral IV will be used to obtain the 7 samples reducing needle pokes to one, ideally. Trials will be separated by at least 1wk, but not more than 4wk. Blood samples collected during the OGTT (all time points) will be assessed for metabolic and satiety signally hormone responses (ie. insulin). All subjects will also be asked to provide a saliva sample for genetic analysis. Genetic analysis will be performed by the company 23 \& Me. Subjects will also be asked to provide a midstream urine sample 30 minutes prior to the completion of the OGTT (90min time point +/10 mins). This is to allow for the analysis of caffeine and caffeine metabolites present in the urine, which will give insight into how caffeine is metabolized and excreted differently among individuals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, double blind, crossover design
| Arm | Type | Receives |
|---|---|---|
| Acute energy drink - Control | Placebo comparator | Dietary Supplement: Acute energy drink - PlaceboColoured Water was given 40 min prior to the OGTT test. |
| Acute energy drink - Caffeine | Active comparator | Dietary Supplement: Acute energy drink - CaffeinSugar Free energy drink at 5mg/kg caffeine was given 40 min prior to OGTT test. |
| Acute energy drink- Decaf | Sham comparator | Dietary Supplement: Acute energy drink - DecafSugar free decaf energy drink (vitamins only) was given 40 min prior to OGTT test. Amount of drink was same as that of Caffeine |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male and female: Current data indicates no hormonal (menstrual cycle) or sex influence on caffeine pharmacokinetics or caffeine-induced insulin resistance.
- Aged 13-19: This age group has been shown to be key consumers of caffeinated energy drinks, and this study is specifically looking at the effects of these beverages in those of adolescent age.
- Lean and Obese: Individuals will be listed as obese if their Body Mass Index is greater or equal to the 85th percentile.
Key exclusion criteria (1 listed)
- Participants will be excluded if they have underlying medical conditions affecting glucose tolerance, for example, inhaled steroid use, pancreatitis, diabetes, glucose intolerance etc. Any underlying condition affecting glucose tolerance would negatively skew results.
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 |
|---|---|---|
| Acute energy drink - PlaceboColored water | Dietary supplement | Acute energy drink - Control |
| Acute energy drink - CaffeinSugar free energy drink at 5mg/kg caffeine | Dietary supplement | Acute energy drink - Caffeine |
| Acute energy drink - DecafSugar free decaf energy drink (vitamins only) | Dietary supplement | Acute energy drink- Decaf |
Primary outcome
Glucose tolerance
Time frame: 120 min
Participants will undergo an oral glucose tolerance test(OGTT), following administration of either a water placebo(control), a caffeine-free CCED or a caffeine-containing CCED.
1 secondary outcome
Metabolomics
Time frame: 120 min
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute energy drink - Caffein and Acute energy drink - Decaf in people with Nutrition and Pediatric Obesity, run by University of Calgary 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 1 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: withdrawn, as of the sponsor's last update on 7 Nov 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 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Glucose tolerance (time frame: 120 min). 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 7 Nov 2022.