A Randomized Study to Examine the Ability of a Caffeine-Based Energy Drink to Impact Energy Expenditure, Fat Oxidation, Reaction Time, and Other Perceptual Indicators

NCT05998096 | Completed

• 1 other identifier: IRB-23-95
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the changes in energy expenditure, fat oxidation, reaction time, and perceptual indicators of energy and focus after acute ingestion of a caffeine-based energy drink. Approximately 60 healthy adults aged 18-50 will be recruited for a randomized, double-blind, placebo-controlled study. They will undergo baseline measurements for energy expenditure, fat and carbohydrate oxidation, reaction time, cognition, and perceptual indicators of energy, focus, and concentration. After 28 days, these measurements will be taken again, comparing the effects of a caffeine-based energy drink versus a placebo.

Conditions

Energy Expenditure; Cognition; Reaction Time

Keywords

energy expenditure; cognition; reaction time

Outcome Measures

Primary Outcomes (1)

• Energy expenditure (kcals/min)

  Impact of a caffeine-based energy drink ingestion on energy expenditure (calorie burning)

  28 days

Secondary Outcomes (8)

• Rates of fat oxidation

  28 days

• Energy Visual Analog Scale

  28 days

• Focus Visual Analog Scale

  28 days

• Concentration Visual Analog Scale

  28 days

• Simple reaction time

  28 days

Other Outcomes (3)

• Self-reported adverse events

  28 days

• Heart Rate

  28 days

• Blood Pressure

  28 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (void of all actives)

Dietary Supplement: Placebo

Caffeine-Based Energy Drink

ACTIVE COMPARATOR

Caffeine-based energy drink containing 200 mg caffeine

Dietary Supplement: Caffeine-Based Energy Drink

Interventions

Caffeine-Based Energy Drink DIETARY_SUPPLEMENT

Caffeine-based energy drink containing 200 mg caffeine

Caffeine-Based Energy Drink

Placebo DIETARY_SUPPLEMENT

Placebo void of all active ingredients

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, is 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 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 a 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 6. 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) 7. Currently prescribed statin drugs (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) or any hypertension medications (i.e., Beta-blockers, ACE Inhibitors, Alpha-blockers, 8. Vasodilators, etc.) or any other medication at the discretion of the principal investigator 9. Current smoker (\>10 cigarettes per day) 10. Participants who are lactating, pregnant, or planning to become pregnant History of alcohol or substance abuse in the 6 months prior to screening 11. Receipt or use of an investigational product in another research study within 60 days of beginning the study protocol 12. 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 13. 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 Officials

• Chad M Kerksick, PhD

  Lindenwood University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Conditions will be packaged into non-descript, identical cans with identical flavoring.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel study design

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: September 1, 2023
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)