Acute Effects of Fitness Drink Formulas on Energy Expenditure and Fat Metabolism

Fatigue Clinical Trial

Official title:

The Acute Effects of Fitness Drink Formulas Containing 100 mg and 140 mg of Caffeine on Energy Expenditure and Fat Metabolism in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04455009
• Other study ID #: BIO-17-13679
• Status: Completed
• Phase: N/A
• Start date: March 8, 2018
• Est. completion date: November 28, 2018

Study information

• Verified date: June 2020
• Source: University of Central Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this investigation was to examine the acute effects of consuming two different fitness drink formulas on the physiological response at rest and to exercise in healthy men and women.

Description:

Thermogenic fitness drinks containing ~200mg of caffeine have been reported to accelerate the metabolism, increase energy, and consequently promote increased fat oxidation. However, determination of the efficacy of lower caffeine concentrations may provide additional options for individuals with preferences for reduced caffeine intake. Therefore, the aim of this study was to evaluate different fitness drink formulas containing a total of 100mg and 140mg of caffeine on the physiological response at rest and to exercise.

This study utilized a randomized, double-blind, placebo-controlled design. All participants completed three testing visits during which they consumed the placebo, the 100mg caffeine formula, and the 140mg caffeine formula. Blood samples, blood pressure, heart rate, resting energy expenditure, substrate oxidation, and neurocognitive assessments were collected at baseline and repeated 30, 60, and 90 minutes post-ingestion. Immediately following the last cognitive assessment, a maximal graded exercise test with gas analysis was conducted on a cycle ergometer to evaluate physical performance and maximal fat oxidation during exercise as well as the physiological response prior to and following exercise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 28, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Young adult men and women between the ages of 18 and 35 years old.

• Participant is deemed by the investigator to be healthy and free of any physical limitations determined by physical activity readiness questionnaire (PAR-Q+) and medical and activity history questionnaire (MHQ).

• Participants will be required to be recreationally-active (defined according to American College of Sports Medicine standards of at least 150 minutes exercise per week and verified by information provided in the MHQ).

• Participant is willing to abstain from dietary supplementation throughout the duration of the study as indicated in the Informed Consent.

• Participant understands the study procedures and signs forms providing informed consent to participate in the study.

Exclusion Criteria:

• Inability to perform physical exercise, as determined by the PAR-Q+.

• Any "Yes" response in the PAR-Q+.

• History of hypertension, metabolic, hepatorenal, musculoskeletal, autoimmune or neurological disease, as determined by the MHQ.

• Regular consumption of greater than 250 mg per day of caffeine

• Currently taking thyroid, antihyperlipidemic, hypoglycemic, anti-hypertensive or androgenic medications.

• Taking any other nutritional supplement or performance-enhancing drug (determined from MHQ) that may interfere with the outcome variables of the study.

• Pregnancy (determined from MHQ).

Related Conditions & MeSH terms

• Caffeine
• Cognitive Change
• Diet, Healthy
• Fat Burn
• Fatigue

Intervention

Dietary Supplement:
• Fitness Drink Formula
Single drink provided following baseline assessments

Locations

Country	Name	City	State
United States	Kinesiology Laboratories	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Central Florida	Celsius Holdings, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in resting energy expenditure/substrate oxidation	Estimates from gas exchange analysis via indirect calorimetry	Baseline, 30, 60, and 90 min post-ingestion
Primary	Change in energy expenditure/substrate oxidation in response to exercise	Estimates from gas exchange analysis via indirect calorimetry	>90 min post-ingestion (pre/peri/post maximal graded exercise test)
Primary	Change in resting serum glycerol	Obtained from blood draw of the superficial forearm vein	Baseline, 30, 60, and 90 min post-ingestion
Primary	Change in oxygen consumption/carbon dioxide production in response to exercise	Estimates from gas exchange analysis via indirect calorimetry	>90 min post-ingestion (pre/peri/post maximal graded exercise test)
Primary	Change in resting minute ventilation	Estimates from gas exchange analysis via indirect calorimetry	Baseline, 30, 60, and 90 min post-ingestion
Primary	Change in minute ventilation in response to exercise	Estimates from gas exchange analysis via indirect calorimetry	>90 min post-ingestion (pre/peri/post maximal graded exercise test)
Secondary	Change in Automated Neuropsychological Assessment Metrics (ANAM) screening	Measures from mood scale, go/no go test, Stroop test	Baseline, 30, 60, and 90 min post-ingestion
Secondary	Change in resting blood pressure response	Measured via automated blood pressure monitor	Baseline, 30, 60, and 90 min post-ingestion
Secondary	Change in resting heart rate/heart rate variability	Measured via chest-based heart rate monitor	Baseline, 30, 60, and 90 min post-ingestion
Secondary	Change in heart rate/heart rate variability in response to exercise	Measured via chest-based heart rate monitor	>90 min post-ingestion (pre/peri/post maximal graded exercise test)
Secondary	Change in power output	Obtained via cycle ergometer during the maximal graded exercise test	>90 min post-ingestion