CClinicalTrials.gg
CompletedNCT06308731EDXUpdated Oct 17, 2024

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

An interventional study of Caffeine-Based Energy Drink and Placebo in Substrate Oxidation, Energy Expenditure and Reaction Time, sponsored by Lindenwood University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-17.

Sponsored by Lindenwood University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Substrate Oxidation
  • Energy Expenditure
  • Reaction Time
  • Cognition
  • Exercise Performance

Keywords

  • energy drink
  • exercise performance
03

In context

Lead sponsor

Lindenwood University is the lead sponsor of 29 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Caffeine-Based Energy Drink

    12 oz Caffeine-based energy drink providing 200 mg caffeine

    Dietary Supplement: Caffeine-Based Energy Drink

  • Placebo comparator
    Placebo

    12 oz placebo void of all active ingredients

    Other: Placebo

Interventions

  • Dietary supplementCaffeine-Based Energy Drink

    Energy drink with 200 mg caffeine

  • OtherPlacebo

    Placebo

06

What researchers measure

Primary outcomes

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

    Fat oxidation rate (grams/min) during exercise

    Time frame: 150 minutes during exercise

Secondary outcomes

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

    Energy expenditure (kcals/min)

    Time frame: 150 minutes during exercise

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

    Carbohydrate oxidation rates (grams/min)

    Time frame: 150 minutes during exercise

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

    Plasma glycerol concentration

    Time frame: 150 minutes after intervention ingestion

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

    Plasma free fatty acid concentration

    Time frame: 150 minutes after intervention ingestion

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

    Rating of Perceived Exertion (RPE) scale

    Time frame: 150 minutes after intervention ingestion

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

    Cycling time trial

    Time frame: 150 minutes after intervention ingestion

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

    Simple/ choice reaction time

    Time frame: 150 minutes after intervention ingestion

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

    Trail making test

    Time frame: 150 minutes after intervention ingestion

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

    Serial 7 Cognitive processing test

    Time frame: 150 minutes after intervention ingestion

Other outcomes

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

    Self-reported adverse events

    Time frame: 3 weeks

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

    Heart rate (bpm)

    Time frame: 3 weeks

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

    Blood Pressure (mmHg)

    Time frame: 3 weeks

07

Study locations

1 site
  • Exercise and Performance Nutrition Laboratory
    Saint Charles, Missouri 63301, United States
08

References and documents

Individual participant data

Plan to share: No — Investigators do not plan to make individual participant data available to other researchers

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06308731
Lead sponsor
Lindenwood University
Responsible party
Sponsor
First posted
Mar 13, 2024
Start date
Jan 19, 2024
Primary completion
Sep 16, 2024
Completion
Sep 16, 2024
Last update
Oct 17, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion