Energy Drink Effects on Performance, Mood, and Cardiovascular Outcomes

NCT05559372 | Completed DMC

• 1 other identifier: 202107364
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

Energy drinks are widely promoted to increase energy, enhance mental alertness, and improve physical performance. ccording to the National Center for Complementary and Integrative Health (NCCIH) at NIH \[1\], next to multivitamins, energy drinks are the most popular dietary supplement consumed by American teens and young adults. No two energy drinks are the same, with each using different ingredients. Traditionally, energy drinks contained caffeine, sugar, ginseng and B-vitamins, but newer competitors are bringing different formulations to the market that are also low-calorie/low-sugar and that contain other performance enhancing ingredients, such as beta-alanine and l-citrulline. There are also significant concerns regarding the safety of energy drink consumption. Unfortunately, there are few studies that have (1) examined the effects of energy drink consumption on performance and cardiovascular safety, nor (2) compared these effects among brands with different formulations to examine their safety and efficacy relative to each other and such studies are desperately needed, especially with the growing popularity of energy drinks \[3,4\].

Conditions

Caffeine; Exercise Performance; Energy Drink; Cardiovascular Safety; Mood

Outcome Measures

Primary Outcomes (3)

• Maximal Exercise Performance

  Maximal oxygen consumption during ramp cycle test

  50-minutes after the intervention

• Sub-maximal Exercise Performance

  Ventilatory Threshold during ramp cycle test

  50-minutes after the intervention

• Fatiguing Isometric Exercise Performance

  Total impulse (Force\*time) during sub-maximal isometric fatigue test at 40% of maximal force production

  65-minutes after the intervention

Secondary Outcomes (7)

• Mood

  80-minutes after the intervention

• Change in Systolic Blood Pressure

  Pre-intervention, 40-minutes Post-intervention, 85-minutes Post-intervention

• Change in Diastolic Blood Pressure

  Pre-intervention, 40-minutes Post-intervention, 85-minutes Post-intervention

• Change in Heart Rate

  Pre-intervention, 40-minutes Post-intervention, 85-minutes Post-intervention

• Change in Rate Pressure Product

  Pre-intervention, 40-minutes Post-intervention, 85-minutes Post-intervention

Other Outcomes (7)

• Maximal Isometric Force Production

  Pre-intervention, 65-minutes Post-Intervention, 70-minutes Post-Intervention, 74-minutes Post-Intervention

• Time Completed During Fatiguing Isometric Exercise Performance

  72-min Post-intervention

• Force During Fatiguing Isometric Exercise Performance

  65-minutes after the intervention

Study Arms (3)

Nutrabolt C4 Energy Drink Carbonated

EXPERIMENTAL

16 oz

Dietary Supplement: Acute energy drink or placebo consumption

Monster Energy Original

ACTIVE COMPARATOR

16 oz

Dietary Supplement: Acute energy drink or placebo consumption

Placebo

PLACEBO COMPARATOR

16 oz carbonated placebo

Dietary Supplement: Acute energy drink or placebo consumption

Interventions

Acute energy drink or placebo consumption DIETARY_SUPPLEMENT

Participants consumed either 16 oz of Nutrabolt C4 Energy Carbonated, Monster Energy Original, or Placebo in randomized order in three separate visits separated by 7±3 days.

Monster Energy Original; Nutrabolt C4 Energy Drink Carbonated; Placebo

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Eligibility criteria (responses needed to be considered eligible in parentheses) are: * Are you an assigned biological male? (Yes) * Are you between the ages of 20 and 35 years? (Yes) * Do you performed planned physical activity (i.e., planned walk/jog/run, bicycle ride, resistance exercise, sport participation, etc) on 3 or more days per week? (Yes) * Do you consume 21 or more servings of \>=6 fl ounces of caffeinated beverages each week? (No) * Do you have a current illness that would impede participation in the study? (No) * Has your doctor ever said that you have a heart condition or high blood pressure? (No) * Do you feel pain in your chest at rest, during your activities of daily living, or when you do physical activity? (No) * Do you lose balance because of dizziness (unrelated to over-breathing) or have you lost consciousness in the last 12 months (unrelated to a head injury)? (No) * Do you currently have a bone, joint, or soft tissue injury that could be made worse by becoming more physically active? (No) * Has your doctor ever said that you should only do physical activity if it is medically supervised? (No) * Do you utilize nicotine or cannabis? (No) * Do you currently use a prescription ADD/ADHD, anti-depressant, or other central acting medication, or were you previously diagnosed with ADD/ADHD, clinical depression, or other mental health condition? (No) * Have you chronically (\>6 months) abused illicit drugs or alcohol? (No) * Are you currently being treated for metabolic syndrome or have you been clinically diagnosed with or taking medication for a metabolic-disorder including pre-diabetes, type II diabetes, high blood pressure, or obesity? (No) * Have you been clinically diagnosed with a digestive disorder or sensitivity, or do you regularly utilize over-the-counter or dietary supplements to support gastrointestinal pain or discomfort? (No) * Have you ever been diagnosed with an allergy to any ingredient present in the study treatments which are commercially available energy drinks, including but not limited to caffeine, artificial sweeteners (e.g., sucralose, acesulfame potassium), niacin, maltodextrin, ginseng? (No) * Are you currently a competitive athlete? (No) * Are you willing and unwilling and able to comply with the controls or experimental conditions of the study, as described in the informed consent document? (Yes)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Nathaniel Jenkins: lead

Study Sites (1)

Integrative Laboratory of Applied Physiology and Lifestyle Medicine

Iowa City, Iowa, 52242, United States

Location

Related Publications (4)

• https://www.nccih.nih.gov/health/energy-drinks

  BACKGROUND

• Global energy drinks market: insights, market size, share, growth, trends analysis and forecast to 2021. AIM Market Insight. April 2015. Available at: https://www.researchandmarkets.com/research/mbbjvv/global_energy. Accessed December 20, 2017

  BACKGROUND

• De Sanctis V, Soliman N, Soliman AT, Elsedfy H, Di Maio S, El Kholy M, Fiscina B. Caffeinated energy drink consumption among adolescents and potential health consequences associated with their use: a significant public health hazard. Acta Biomed. 2017 Aug 23;88(2):222-231. doi: 10.23750/abm.v88i2.6664.

  PMID: 28845841 BACKGROUND

• Al-Shaar L, Vercammen K, Lu C, Richardson S, Tamez M, Mattei J. Health Effects and Public Health Concerns of Energy Drink Consumption in the United States: A Mini-Review. Front Public Health. 2017 Aug 31;5:225. doi: 10.3389/fpubh.2017.00225. eCollection 2017.

  PMID: 28913331 BACKGROUND

Study Design

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

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 29, 2022
• Study Start: October 25, 2021
• Primary Completion: March 4, 2022
• Study Completion: March 4, 2022
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

US (1)