Metabolic Effects of a Thermogenic Ready-to-drink Beverage

NCT ID: NCT05194475

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-18
• Study Completion Date: 2022-05-06

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.

Conditions

Metabolic Rate; Metabolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Thermogenic Ready-to-drink Beverage

Arm in which a thermogenic ready-to-drink beverage is ingested.

Group Type: EXPERIMENTAL

Thermogenic Ready-to-drink Beverage

Intervention Type: OTHER

Thermogenic ready-to-drink beverage, which will be ingested by the participant.

Placebo Ready-to-drink Beverage

Arm in which a placebo ready-to-drink beverage is ingested.

Group Type: PLACEBO_COMPARATOR

Placebo Ready-to-drink Beverage

Intervention Type: OTHER

Placebo ready-to-drink beverage, which will be ingested by the participant.

Interventions

Thermogenic Ready-to-drink Beverage

Thermogenic ready-to-drink beverage, which will be ingested by the participant.

Intervention Type: OTHER

Placebo Ready-to-drink Beverage

Placebo ready-to-drink beverage, which will be ingested by the participant.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

EHP Labs

UNKNOWN

Sponsor Role: collaborator

Texas Tech University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grant M Tinsley, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University

Locations

Department of Kinesiology & Sport Management

Lubbock, Texas, United States

Countries

United States

Other Identifiers

IRB2021-676

Identifier Type: -

Identifier Source: org_study_id