Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03512496 |
| Other study ID # |
REB14-1093 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2014 |
| Est. completion date |
June 1, 2015 |
Study information
| Verified date |
April 2018 |
| Source |
University of Calgary |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
