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Metabolic and Genetic Impacts of Energy Drinks in Youth

Primary Purpose

Nutrition, Pediatric Obesity, Pediatric

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Acute energy drink - Placebo
Acute energy drink - Caffein
Acute energy drink - Decaf
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nutrition focused on measuring Energy Drink, Pediatric, Metabolism, Glucose, Caffeine, Obesity, Nutrition, Metabolomics, Health Behavior, Glucose Intolerance

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Sham Comparator

Arm Label

Acute energy drink - Control

Acute energy drink - Caffeine

Acute energy drink- Decaf

Arm Description

Coloured Water was given 40 min prior to the OGTT test.

Sugar Free energy drink at 5mg/kg caffeine was given 40 min prior to OGTT test.

Sugar free decaf energy drink (vitamins only) was given 40 min prior to OGTT test. Amount of drink was same as that of Caffeine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Metabolomics
Metabolomics will be assessed in serum collected at all time points of OGTT to analyze metabolic responses.

Full Information

First Posted
April 5, 2018
Last Updated
November 1, 2022
Sponsor
University of Calgary
Collaborators
Natural Sciences and Engineering Research Council, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03512496
Brief Title
Metabolic and Genetic Impacts of Energy Drinks in Youth
Official Title
Examining the Metabolic and Genetic Impacts of Acute Energy Drink Consumption in Youth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Study Start Date
December 1, 2014 (Actual)
Primary Completion Date
June 1, 2015 (Actual)
Study Completion Date
June 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
Collaborators
Natural Sciences and Engineering Research Council, Canada

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition, Pediatric Obesity, Pediatric, Caffeine, Metabolism Disorder, Glucose, Health Behavior, Glucose Intolerance
Keywords
Energy Drink, Pediatric, Metabolism, Glucose, Caffeine, Obesity, Nutrition, Metabolomics, Health Behavior, Glucose Intolerance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, double blind, crossover design
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Randomized, double blind, crossover design
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute energy drink - Control
Arm Type
Placebo Comparator
Arm Description
Coloured Water was given 40 min prior to the OGTT test.
Arm Title
Acute energy drink - Caffeine
Arm Type
Active Comparator
Arm Description
Sugar Free energy drink at 5mg/kg caffeine was given 40 min prior to OGTT test.
Arm Title
Acute energy drink- Decaf
Arm Type
Sham Comparator
Arm Description
Sugar free decaf energy drink (vitamins only) was given 40 min prior to OGTT test. Amount of drink was same as that of Caffeine
Intervention Type
Dietary Supplement
Intervention Name(s)
Acute energy drink - Placebo
Intervention Description
Colored water
Intervention Type
Dietary Supplement
Intervention Name(s)
Acute energy drink - Caffein
Intervention Description
Sugar free energy drink at 5mg/kg caffeine
Intervention Type
Dietary Supplement
Intervention Name(s)
Acute energy drink - Decaf
Intervention Description
Sugar free decaf energy drink (vitamins only)
Primary Outcome Measure Information:
Title
Glucose tolerance
Description
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.
Time Frame
120 min
Secondary Outcome Measure Information:
Title
Metabolomics
Description
Metabolomics will be assessed in serum collected at all time points of OGTT to analyze metabolic responses.
Time Frame
120 min
Other Pre-specified Outcome Measures:
Title
Incretins
Description
Incretin responses in terms of Area under the Curve (AUC) will be analyzed.
Time Frame
120 min
Title
Genetic interactions
Description
Genetic interactions to responses using comprehensive genotyping for polymorphism at defined loci.
Time Frame
120 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada

12. IPD Sharing Statement

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Metabolic and Genetic Impacts of Energy Drinks in Youth

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