Clinical trial NCT05194475: Metabolic Effects of a Thermogenic Ready-to-drink Beverage
Official title: Metabolic Effects of a Thermogenic Ready-to-drink Beverage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Rate
Metabolism
Keywords: dietary supplement
energy drink
thermogenic
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: EHP Labs
First posted: 2022-01-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study is a randomized, double-blind, placebo-controlled crossover trial examining the metabolic effects of a novel ready-to-drink (RTD) beverage. Healthy adult males and females will be recruited for participation. Each participant will complete two conditions in random order: 1) RTD thermogenic beverage ; and 2) placebo (consisting of the flavoring of the thermogenic beverage without the active ingredients). In each condition, metabolism (resting metabolic rate), hemodynamic (heart rate and blood pressure), and subjective (ratings of energy, focus, concentration, alertness, and mood) assessments will be completed at baseline, 30 minutes after beverage consumption, and 30 minutes after the second round of assessments.

Detailed description: The primary purpose of this study is to report the metabolic effects of a new ready-to-drink (RTD) version of EHP Labs OxyShred Thermogenic Fat Burner. Additionally, the effect of this product on hemodynamic variables and subjective ratings of energy, focus, concentration, alertness, and mood will be reported.

OxyShred Thermogenic Fat Burner (EHP Labs) is a popular dietary supplement for those seeking to increase energy and reduce body fat. While this product is commercially available as a powdered dietary supplement, a new RTD formulation is currently being developed. While the RTD formula will be similar to the current version of the product, research specifically conducted with the RTD version is needed to definitively support product claims and demonstrate the potential effects of this novel product. Additionally, there is a need to better understand the effects of caffeine-containing, thermogenic products among the variety of groups who may consume these products (e.g., males vs. females, inactive vs. active, etc.).

This study is a randomized, double-blind, placebo-controlled crossover trial examining the metabolic effects of a novel ready-to-drink (RTD) beverage. Healthy adult males and females will be recruited for participation. Each participant will complete two conditions in random order: 1) RTD thermogenic beverage ; and 2) placebo (consisting of the flavoring of the thermogenic beverage without the active ingredients). In each condition, metabolism (resting metabolic rate), hemodynamic (heart rate and blood pressure), and subjective (ratings of energy, focus, concentration, alertness, and mood) assessments will be completed at baseline, 30 minutes after beverage consumption, and 30 minutes after the second round of assessments.

Eligibility criteria: The inclusion criteria are:

* Between the ages of 18 and 40.
* Body mass between 50 - 110 kg (110 - 220 lbs.).
* Either: (A) Resistance-trained, defined as completing 3+ resistance training sessions per week for at least two years prior to screening; full body (all upper body and lower body major muscle groups) must be trained at least once weekly, OR (B) non-resistance trained, defined as never having followed a structured resistance training program.
* Perform ≤ 30 minutes of high-intensity interval training per week.
* Perform ≤ 60 minutes of steady state endurance exercise per week.
* Regular caffeine consumption (due to the presence of caffeine in the commercially available dietary supplement). This will be defined as an average self-reported daily intake of 200+ mg of caffeine, which is equivalent to approximately 2 cups of coffee.

The exclusion criteria are:

* Failing to meet any of the aforementioned inclusion criteria.
* Presence of any known disease or medical condition which could be negatively affected by consumption of the beverage. This includes cardiovascular disease or condition; liver disease or disorder; other metabolic disease or disorder; or other conditions that could reasonably be deemed to contraindicate the study protocol.
* Pregnant or breastfeeding, based on self-report (for female participants).
* Taking medication which could reasonably make participation unsafe for the participant or influence study outcomes. Specifically, use of any prescription stimulant (e.g., dextroamphetamine (Dexedrine®), dextroamphetamine/amphetamine combination product (Adderall®), methylphenidate (Ritalin®, Concerta®), or similar stimulants) precludes participation in this study.
* Self-reported caffeine sensitivity, as indicated by unwanted side effects when caffeine is consumed.
* Allergy to any of the ingredients in the RTD beverage.
* Presence of a pacemaker or other implanted electrical device
* Self-reported claustrophobia (due to metabolism testing)

Primary outcomes:
measure: Resting metabolic rate
timeFrame: 140 minutes
measure: Respiratory quotient
timeFrame: 140 minutes
Secondary outcomes:
measure: Subjective rating of energy
timeFrame: 140 minutes
measure: Subjective rating of focus
timeFrame: 140 minutes
measure: Subjective rating of concentration
timeFrame: 140 minutes
measure: Subjective rating of alertness
timeFrame: 140 minutes
measure: Subjective rating of mood
timeFrame: 140 minutes
measure: Heart rate
timeFrame: 140 minutes
measure: Systolic blood pressure
timeFrame: 140 minutes
measure: Diastolic blood pressure
timeFrame: 140 minutes
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Department of Kinesiology & Sport Management
state: Texas
Study officials:
affiliation: Texas Tech University
name: Grant M Tinsley, PhD
role: PRINCIPAL_INVESTIGATOR
References: