Metabolic Effects of a Thermogenic Ready-to-drink Beverage

Metabolism Clinical Trial

Official title:

Metabolic Effects of a Thermogenic Ready-to-drink Beverage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05194475
• Other study ID #: IRB2021-676
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Metabolic Rate
• Metabolism

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