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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05194475
Other study ID # IRB2021-676
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 18, 2022
Est. completion date May 6, 2022

Study information

Verified date August 2022
Source Texas Tech University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date May 6, 2022
Est. primary completion date May 6, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Thermogenic Ready-to-drink Beverage
Thermogenic ready-to-drink beverage, which will be ingested by the participant.
Placebo Ready-to-drink Beverage
Placebo ready-to-drink beverage, which will be ingested by the participant.

Locations

Country Name City State
United States Department of Kinesiology & Sport Management Lubbock Texas

Sponsors (2)

Lead Sponsor Collaborator
Texas Tech University EHP Labs

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resting metabolic rate Resting metabolic rate from indirect calorimetry expressed as kilocalories expended per unit time (e.g., kcal/min). 140 minutes
Primary Respiratory quotient Respiratory quotient from indirect calorimetry in arbitrary units, which reflects the proportion of carbohydrate and fat oxidized at rest. 140 minutes
Secondary Subjective rating of energy Subjective rating of energy as assessed by visual analog scale. 140 minutes
Secondary Subjective rating of focus Subjective rating of focus as assessed by visual analog scale. 140 minutes
Secondary Subjective rating of concentration Subjective rating of concentration as assessed by visual analog scale. 140 minutes
Secondary Subjective rating of alertness Subjective rating of alertness as assessed by visual analog scale. 140 minutes
Secondary Subjective rating of mood Subjective rating of mood as assessed by visual analog scale. 140 minutes
Secondary Heart rate Heart rate from automated sphygmomanometer expressed in beats per minute. 140 minutes
Secondary Systolic blood pressure Systolic blood pressure from automated sphygmomanometer expressed in beats per minute. 140 minutes
Secondary Diastolic blood pressure Diastolic blood pressure from automated sphygmomanometer expressed in beats per minute. 140 minutes
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