Metabolic Effects of a Thermogenic Ready-to-drink Beverage

NCT05194475 | Completed

• 1 other identifier: IRB2021-676
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Rate; Metabolism

Keywords

dietary supplement; energy drink; thermogenic

Outcome Measures

Primary Outcomes (2)

• Resting metabolic rate

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

  140 minutes

• Respiratory quotient

  Respiratory quotient from indirect calorimetry in arbitrary units, which reflects the proportion of carbohydrate and fat oxidized at rest.

  140 minutes

Secondary Outcomes (8)

• Subjective rating of energy

  140 minutes

• Subjective rating of focus

  140 minutes

• Subjective rating of concentration

  140 minutes

• Subjective rating of alertness

  140 minutes

• Subjective rating of mood

  140 minutes

Study Arms (2)

Thermogenic Ready-to-drink Beverage

EXPERIMENTAL

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

Other: Thermogenic Ready-to-drink Beverage

Placebo Ready-to-drink Beverage

PLACEBO COMPARATOR

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

Other: Placebo Ready-to-drink Beverage

Interventions

Thermogenic Ready-to-drink Beverage OTHER

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

Thermogenic Ready-to-drink Beverage

Placebo Ready-to-drink Beverage OTHER

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

Placebo Ready-to-drink Beverage

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Texas Tech University: lead
• EHP Labs: collaborator

Study Sites (1)

Department of Kinesiology & Sport Management

Lubbock, Texas, 79409, United States

Location

Study Officials

• Grant M Tinsley, PhD

  Texas Tech University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 18, 2022
• Study Start: January 18, 2022
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

US (1)