Metabolic and Genetic Impacts of Energy Drinks in Youth

NCT03512496 | Withdrawn

• 1 other identifier: REB14-1093
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  120 min

Secondary Outcomes (1)

• Metabolomics

  120 min

Other Outcomes (2)

• Incretins

  120 min

• Genetic interactions

  120 min

Study Arms (3)

Acute energy drink - Control

PLACEBO COMPARATOR

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

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.

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

Dietary Supplement: Acute energy drink - Decaf

Interventions

Acute energy drink - Placebo DIETARY_SUPPLEMENT

Colored water

Acute energy drink - Control

Acute energy drink - Caffein DIETARY_SUPPLEMENT

Sugar free energy drink at 5mg/kg caffeine

Acute energy drink - Caffeine

Acute energy drink - Decaf DIETARY_SUPPLEMENT

Sugar free decaf energy drink (vitamins only)

Acute energy drink- Decaf

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Natural Sciences and Engineering Research Council, Canada: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

MeSH Terms

Conditions

Pediatric Obesity; Glucose Metabolism Disorders; Health Behavior; Glucose Intolerance; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Behavior; Hyperglycemia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized, double blind, crossover design
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double blind, crossover design

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 30, 2018
• Study Start: December 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 7, 2022

Record last verified: 2018-04

Locations

CA (1)