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

NCT ID: NCT04455009

Last Updated: 2020-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-08

Study Completion Date

2018-11-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Caffeine Diet, Healthy Fat Burn Cognitive Change Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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100mg Caffeine Formula

10kcal drink containing a total of 100 mg of caffeine from a proprietary blend of caffeine, guarana, ginger, and green tea extract containing epigallocatechin gallate

Group Type EXPERIMENTAL

Fitness Drink Formula

Intervention Type DIETARY_SUPPLEMENT

Single drink provided following baseline assessments

140mg Caffeine Formula

10kcal drink containing a total of 140 mg of caffeine from a proprietary blend of caffeine, guarana, ginger, and green tea extract containing epigallocatechin gallate

Group Type EXPERIMENTAL

Fitness Drink Formula

Intervention Type DIETARY_SUPPLEMENT

Single drink provided following baseline assessments

Placebo Formula

non-caloric/non-caffeinated drink

Group Type PLACEBO_COMPARATOR

Fitness Drink Formula

Intervention Type DIETARY_SUPPLEMENT

Single drink provided following baseline assessments

Interventions

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Fitness Drink Formula

Single drink provided following baseline assessments

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Celsius Holdings, Inc.

UNKNOWN

Sponsor Role collaborator

University of Central Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Fukuda, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Central Florida

Locations

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Kinesiology Laboratories

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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BIO-17-13679

Identifier Type: -

Identifier Source: org_study_id

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