Energy Drink Habituation Effects on Young Adults

NCT04223167 | Completed

• 1 other identifier: 2017/1211
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The consumption of energy drinks has significantly increased in recent years but their adverse effects are not yet efficiently known. The objective of the study is to determine the acute effects of energy drink on habitual and non-habitual caffeine consumers and if caffeine consumption habit causes a difference on the hemodynamic and electrophysiologic parameters. This study was conducted on 48 students selected from Aydın Adnan Menderes University. Four main groups were determined according to the results of the application acceptance survey. Blood pressure, electrocardiogram, breath rate, haemoglobin oxygen saturation and bioelectrical impedance analysis were measured before consuming the drinks. After consuming the drinks, measurements were repeated at 30 minutes and 60 minutes. In addition to this, Participant's Situation Anxiety Scale was applied.

Conditions

Healthy Volunteers

Keywords

Energy drink; heart rate variability; habituation

Outcome Measures

Primary Outcomes (2)

• Change in blood pressure from baseline

  At baseline and 60 minutes post energy drink and placebo consumption

• Change in heart rate from baseline

  At baseline and 60 minutes post energy drink and placebo consumption

Secondary Outcomes (1)

• Change in QTc interval from baseline

  At baseline and 60 minutes post energy drink and placebo consumption

Study Arms (4)

Energy Drink 1

EXPERIMENTAL

The participants in this group are caffeine naive and consumed 473 ml Red Bull Energy Drink

Dietary Supplement: Red Bull Energy Drink

Energy Drink 2

EXPERIMENTAL

The participants in this group were low-habitual caffeine consumers with an estimated daily intake of approximately 130 mg caffeine and consumed 473 ml Red Bull Energy Drink

Dietary Supplement: Red Bull Energy Drink

Energy Drink 3

EXPERIMENTAL

The participants in this group were low-habitual caffeine consumers with an estimated daily intake of approximately more than 200 mg caffeine and consumed 473 ml Red Bull Energy Drink

Dietary Supplement: Red Bull Energy Drink

Control

PLACEBO COMPARATOR

The participants in this group are caffeine naive and consumed 473 ml water

Dietary Supplement: Water

Interventions

Red Bull Energy Drink DIETARY_SUPPLEMENT

473 ml Reb Bull Energy Drink

Energy Drink 1; Energy Drink 2; Energy Drink 3

Water DIETARY_SUPPLEMENT

473 ml Water

Control

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers between ages 18-24 years

You may not qualify if:

• body mass index greater than 30 kg/m2
• a systemic disease
• current alcoholism
• smokers
• the participants who has previous adverse reactions to energy drinks

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydin Adnan Menderes University

Aydin, 09010, Turkey (Türkiye)

Location

Related Publications (1)

• Caliskan SG, Kilic MA, Bilgin MD. Acute effects of energy drink on hemodynamic and electrophysiologic parameters in habitual and non-habitual caffeine consumers. Clin Nutr ESPEN. 2021 Apr;42:333-338. doi: 10.1016/j.clnesp.2021.01.011. Epub 2021 Feb 4.

  PMID: 33745602 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Water

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Serife G Caliskan, PhD.

  Aydin Adnan Menderes University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The individuals were identified by collecting the age, weight, height, BMI, caffeine and energy drink consumption habit information by applicant acceptance questionnaire. Based on the applicant acceptance questionnaire 12 subjects were low-habitual caffeine consumers with an estimated daily intake of approximately 130 mg caffeine and named as energy drink 2 (ED2) group, 12 subjects were high-habitual caffeine consumers with an estimated daily intake of approximately more than 200 mg caffeine and named as energy drink 3 (ED3) group, while 24 subjects were caffeine naive (energy drink 1 (ED1) (n=12) and Control (n=12)) .

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 10, 2020
• Study Start: January 20, 2018
• Primary Completion: May 14, 2019
• Study Completion: May 14, 2019
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)