Metabolic Effects of a Thermogenic Ready-to-drink Beverage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Texas Tech University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Resting metabolic rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •The inclusion criteria are:
- •Between the ages of 18 and
- •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.
Exclusion Criteria
- •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)
Arms & Interventions
Thermogenic Ready-to-drink Beverage
Arm in which a thermogenic ready-to-drink beverage is ingested.
Intervention: Thermogenic Ready-to-drink Beverage (Other)
Placebo Ready-to-drink Beverage
Arm in which a placebo ready-to-drink beverage is ingested.
Intervention: Placebo Ready-to-drink Beverage (Other)
Outcomes
Primary Outcomes
Resting metabolic rate
Time Frame: 140 minutes
Resting metabolic rate from indirect calorimetry expressed as kilocalories expended per unit time (e.g., kcal/min).
Respiratory quotient
Time Frame: 140 minutes
Respiratory quotient from indirect calorimetry in arbitrary units, which reflects the proportion of carbohydrate and fat oxidized at rest.
Secondary Outcomes
- Subjective rating of energy(140 minutes)
- Subjective rating of focus(140 minutes)
- Heart rate(140 minutes)
- Subjective rating of concentration(140 minutes)
- Subjective rating of alertness(140 minutes)
- Subjective rating of mood(140 minutes)
- Systolic blood pressure(140 minutes)
- Diastolic blood pressure(140 minutes)