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

NCT06308731 | Completed

• 1 other identifier: 23-26
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

energy drink; exercise performance

Outcome Measures

Primary Outcomes (1)

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

  Fat oxidation rate (grams/min) during exercise

  150 minutes during exercise

Secondary Outcomes (9)

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

  150 minutes during exercise

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

  150 minutes during exercise

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

  150 minutes after intervention ingestion

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

  150 minutes after intervention ingestion

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

  150 minutes after intervention ingestion

Other Outcomes (3)

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

  3 weeks

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

  3 weeks

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

  3 weeks

Study Arms (2)

Caffeine-Based Energy Drink

EXPERIMENTAL

12 oz Caffeine-based energy drink providing 200 mg caffeine

Dietary Supplement: Caffeine-Based Energy Drink

Placebo

PLACEBO COMPARATOR

12 oz placebo void of all active ingredients

Other: Placebo

Interventions

Caffeine-Based Energy Drink DIETARY_SUPPLEMENT

Energy drink with 200 mg caffeine

Caffeine-Based Energy Drink

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lindenwood University: lead

Study Sites (1)

Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, 63301, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All energy drink supplements are provided in identical, unlabeled cans, using a randomization code.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo controlled, crossover design

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: March 13, 2024
• Study Start: January 19, 2024
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)