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Completed

NCT Number: NCT04455009

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kinesiology Laboratories

Orlando, Florida, 32816, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Fitness Drink Formula

Dietary Supplement

Single drink provided following baseline assessments

Primary outcomes

  1. Change in resting energy expenditure/substrate oxidation

    Time frame: Baseline, 30, 60, and 90 min post-ingestion

    Estimates from gas exchange analysis via indirect calorimetry

  2. Change in energy expenditure/substrate oxidation in response to exercise

    Time frame: >90 min post-ingestion (pre/peri/post maximal graded exercise test)

    Estimates from gas exchange analysis via indirect calorimetry

  3. Change in resting serum glycerol

    Time frame: Baseline, 30, 60, and 90 min post-ingestion

    Obtained from blood draw of the superficial forearm vein

  4. Change in oxygen consumption/carbon dioxide production in response to exercise

    Time frame: >90 min post-ingestion (pre/peri/post maximal graded exercise test)

    Estimates from gas exchange analysis via indirect calorimetry

  5. Change in resting minute ventilation

    Time frame: Baseline, 30, 60, and 90 min post-ingestion

    Estimates from gas exchange analysis via indirect calorimetry

  6. Change in minute ventilation in response to exercise

    Time frame: >90 min post-ingestion (pre/peri/post maximal graded exercise test)

    Estimates from gas exchange analysis via indirect calorimetry

Secondary outcomes

  1. Change in Automated Neuropsychological Assessment Metrics (ANAM) screening

    Time frame: Baseline, 30, 60, and 90 min post-ingestion

    Measures from mood scale, go/no go test, Stroop test

  2. Change in resting blood pressure response

    Time frame: Baseline, 30, 60, and 90 min post-ingestion

    Measured via automated blood pressure monitor

  3. Change in resting heart rate/heart rate variability

    Time frame: Baseline, 30, 60, and 90 min post-ingestion

    Measured via chest-based heart rate monitor

  4. Change in heart rate/heart rate variability in response to exercise

    Time frame: >90 min post-ingestion (pre/peri/post maximal graded exercise test)

    Measured via chest-based heart rate monitor

  5. Change in power output

    Time frame: >90 min post-ingestion

    Obtained via cycle ergometer during the maximal graded exercise test

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

  • Celsius Holdings, Inc.

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2020
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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