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Completed

NCT Number: NCT05194475

Metabolic Effects of a Thermogenic Ready-to-drink Beverage

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Kinesiology & Sport Management

Lubbock, Texas, 79409, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Thermogenic Ready-to-drink Beverage

Other

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

Placebo Ready-to-drink Beverage

Other

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

Primary outcomes

  1. Resting metabolic rate

    Time frame: 140 minutes

    Resting metabolic rate from indirect calorimetry expressed as kilocalories expended per unit time (e.g., kcal/min).

  2. 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

  1. Subjective rating of energy

    Time frame: 140 minutes

    Subjective rating of energy as assessed by visual analog scale.

  2. Subjective rating of focus

    Time frame: 140 minutes

    Subjective rating of focus as assessed by visual analog scale.

  3. Subjective rating of concentration

    Time frame: 140 minutes

    Subjective rating of concentration as assessed by visual analog scale.

  4. Subjective rating of alertness

    Time frame: 140 minutes

    Subjective rating of alertness as assessed by visual analog scale.

  5. Subjective rating of mood

    Time frame: 140 minutes

    Subjective rating of mood as assessed by visual analog scale.

  6. Heart rate

    Time frame: 140 minutes

    Heart rate from automated sphygmomanometer expressed in beats per minute.

  7. Systolic blood pressure

    Time frame: 140 minutes

    Systolic blood pressure from automated sphygmomanometer expressed in beats per minute.

  8. Diastolic blood pressure

    Time frame: 140 minutes

    Diastolic blood pressure from automated sphygmomanometer expressed in beats per minute.

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Collaborators

  • EHP Labs

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2022
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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