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

Cognition Clinical Trial

— EDX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06308731
• Other study ID #: 23-26
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2024
• Source: Lindenwood University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Caffeine-Based Energy Drink
Energy drink with 200 mg caffeine

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Exercise and Performance Nutrition Laboratory	Saint Charles	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Lindenwood University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of a caffeine-based energy drink ingestion on adverse events	Self-reported adverse events	3 weeks
Other	Impact of a caffeine-based energy drink ingestion on heart rate	Heart rate (bpm)	3 weeks
Other	Impact of a caffeine-based energy drink ingestion on blood pressure	Blood Pressure (mmHg)	3 weeks
Primary	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	Impact of a caffeine-based energy drink ingestion on energy expenditure rates during exercise.	Energy expenditure (kcals/min)	150 minutes during exercise
Secondary	Impact of a caffeine-based energy drink ingestion on carbohydrate oxidation during exercise	Carbohydrate oxidation rates (grams/min)	150 minutes during exercise
Secondary	Impact of a caffeine-based energy drink ingestion on plasma glycerol concentration	Plasma glycerol concentration	150 minutes after intervention ingestion
Secondary	Impact of a caffeine-based energy drink ingestion on plasma free fatty acid concentration	Plasma free fatty acid concentration	150 minutes after intervention ingestion
Secondary	Impact of a caffeine-based energy drink ingestion on ratings of perceived exertion	Rating of Perceived Exertion (RPE) scale	150 minutes after intervention ingestion
Secondary	Impact of a caffeine-based energy drink ingestion on exercise performance	Cycling time trial	150 minutes after intervention ingestion
Secondary	Impact of a caffeine-based energy drink ingestion on reaction time	Simple/ choice reaction time	150 minutes after intervention ingestion
Secondary	Impact of a caffeine-based energy drink ingestion on trail making test performance	Trail making test	150 minutes after intervention ingestion
Secondary	Impact of a caffeine-based energy drink ingestion on Cognition	Serial 7 Cognitive processing test	150 minutes after intervention ingestion