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Completed

NCT Number: NCT06308731

Exercise-Induced Rates of Fat Oxidation with and Without Ingestion of a Caffeine-Based Energy Drink

The purpose of this study is to evaluate acute changes in rates of fat oxidation during exercise with and without the ingestion of a caffeine-based energy drink.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, 63301, United States

About this study

This study aims to investigate the impact of a caffeinated energy drink on cognitive function and exercise performance in healthy adults. The research will employ a randomized, double-blind, placebo-controlled, crossover design involving 15 participants. Initial screening includes health assessments and completion of a health history questionnaire, as well as a VO2peak assessment. Participants will replicate their diet before every study visit. Subsequent visits involve baseline assessments, ingestion of either a placebo or a caffeinated energy drink, followed by cognitive tests and a cycling exercise bout at moderate intensity, followed by a exercise performance cycling time trial. Measurements, including heart rate, perceived exertion, blood samples, and expired gases, will be collected during and after exercise. The study will have two identical testing visits, separated by at least a week, with participants consuming different beverages to assess their impact on cognitive function and exercise performance.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female participants between 18 - 50 years of age
  • Signed informed consent
  • Healthy defined as currently not being treated for an active cardiac, pulmonary, metabolic, immunological, neurological, respiratory, orthopedic, musculoskeletal, psychiatric, or reproductive disease or disorder. With the research team and principal investigator's discretion, some ongoing treatments will be permitted if a determination is made that the treatment will not increase the risk of study participation and the treatment will not confound with desired study outcomes
  • Physically active which is defined as performing aerobic or resistance-based physical exercise between 2 and 5 times per week
  • Moderate caffeine users (~300 mg/day)
  • Body mass index values will range from >24.0 to < 31.9 kg/m2. The average body mass index for the entire study cohort will be less than 31.99 kg/m2. As such, an ongoing calculation of the recruited cohort's mean body mass index will be maintained and people will only be randomized into the study if the average cohort body mass index value does not exceed 31.99 kg/m2
  • Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, and carry out all study-related procedures

Exclusion criteria

  • Body mass index > 31.9 kg/m2
  • Positive medical history and/or is currently being treated for some form of heart or cardiovascular, neurological impairment, disease or condition, immune disorder or disease, thyroid disease, kidney disease, renal failure, regular dialysis, liver disease, or other diagnosed hepatic impairment
  • Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose > 126 mg/dL)
  • Diagnosed with major affective disorder or other psychiatric disorder that required hospitalization in the prior year
  • History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
  • Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea)
  • Currently prescribed statin drugs (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) or any hypertension medications (i.e., Beta-blockers, ACE Inhibitors, Alpha-blockers, Vasodilators, etc.) or any other medication at the discretion of the principal investigator
  • Current smoker (>10 cigarettes per day)
  • Participants who are lactating, pregnant, or planning to become pregnant
  • History of alcohol or substance abuse in the 6 months prior to screening
  • Receipt or use of an investigational product in another research study within 60 days of beginning the study protocol
  • Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data
  • Extensive travel (>1 month) that will disrupt the original outline of the study protocol

Treatment and study plan

Caffeine-Based Energy Drink

Dietary Supplement

Energy drink with 200 mg caffeine

Placebo

Other

Placebo

Primary outcomes

  1. Impact of a caffeine-based energy drink ingestion on fat oxidation rates during exercise.

    Time frame: 150 minutes during exercise

    Fat oxidation rate (grams/min) during exercise

Secondary outcomes

  1. Impact of a caffeine-based energy drink ingestion on energy expenditure rates during exercise.

    Time frame: 150 minutes during exercise

    Energy expenditure (kcals/min)

  2. Impact of a caffeine-based energy drink ingestion on carbohydrate oxidation during exercise

    Time frame: 150 minutes during exercise

    Carbohydrate oxidation rates (grams/min)

  3. Impact of a caffeine-based energy drink ingestion on plasma glycerol concentration

    Time frame: 150 minutes after intervention ingestion

    Plasma glycerol concentration

  4. Impact of a caffeine-based energy drink ingestion on plasma free fatty acid concentration

    Time frame: 150 minutes after intervention ingestion

    Plasma free fatty acid concentration

  5. Impact of a caffeine-based energy drink ingestion on ratings of perceived exertion

    Time frame: 150 minutes after intervention ingestion

    Rating of Perceived Exertion (RPE) scale

  6. Impact of a caffeine-based energy drink ingestion on exercise performance

    Time frame: 150 minutes after intervention ingestion

    Cycling time trial

  7. Impact of a caffeine-based energy drink ingestion on reaction time

    Time frame: 150 minutes after intervention ingestion

    Simple/ choice reaction time

  8. Impact of a caffeine-based energy drink ingestion on trail making test performance

    Time frame: 150 minutes after intervention ingestion

    Trail making test

  9. Impact of a caffeine-based energy drink ingestion on Cognition

    Time frame: 150 minutes after intervention ingestion

    Serial 7 Cognitive processing test

Other outcomes

  1. Impact of a caffeine-based energy drink ingestion on adverse events

    Time frame: 3 weeks

    Self-reported adverse events

  2. Impact of a caffeine-based energy drink ingestion on heart rate

    Time frame: 3 weeks

    Heart rate (bpm)

  3. Impact of a caffeine-based energy drink ingestion on blood pressure

    Time frame: 3 weeks

    Blood Pressure (mmHg)

Sponsors and collaborators

Lead sponsor

Lindenwood University

Other

Registry information

Official study title

A Crossover Study to Examine Exercise-Induced Rates of Fat Oxidation with and Without Ingestion of a Caffeine-Based Energy Drink

Acronym: EDX

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2024
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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