NCT04539054

Brief Summary

The primary purpose of this study was to examine the acute effects of a multi-ingredient pre-workout supplement versus an ergogenic dose of caffeine (6 mg/kg) on energy expenditure during low-intensity exercise. The effects of these substances on substrate utilization, gas exchange, and psychological factors were also investigated. Twelve males (mean ± SD: age = 22.8 ± 2.4 years) completed three bouts of 60-min of treadmill exercise at 4.8-6.4 km/hr on separate days after consuming a pre-workout supplement, 6 mg/kg of caffeine, or placebo in a randomized fashion. The pre-workout and caffeine supplements resulted in significantly greater energy expenditure (p \< 0.001, p = 0.006, respectively), VO2 (p \< 0.001, p = 0.007, respectively), VCO2 (p = 0.006, p = 0.049, respectively), and VE (p \< 0.001, p = 0.007, respectively), but not rates of fat or carbohydrate oxidation or respiratory exchange ratio compared to placebo (collapsed across condition). In addition, the pre-workout supplement increased feelings of alertness (p = 0.015) and focus (p = 0.005) 30-minutes post-ingestion and decreased feelings of fatigue (p = 0.014) during exercise compared to placebo (collapsed across condition). Thus, the pre-workout supplement increased energy expenditure and measures of gas exchange to the same extent as 6 mg/kg of caffeine with concomitant increased feelings of alertness and focus and decreased feelings of fatigue.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 4, 2020

Completed
Last Updated

September 4, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

August 26, 2020

Last Update Submit

August 31, 2020

Conditions

Healthy

Keywords

supplementationergogenic aidmetabolic rateenergysubstrate utilization

Outcome Measures

Primary Outcomes (1)

  • Energy expenditure

    Measurement of caloric expenditure via gas exchange

    Measured continuously during 60 minutes of exercise for all three supplement conditions

Secondary Outcomes (9)

  • Oxygen consumption

    Measured continuously during 60 minutes of exercise for all three supplement conditions

  • Carbon dioxide production

    Measured continuously during 60 minutes of exercise for all three supplement conditions

  • Minute ventilation

    Measured continuously during 60 minutes of exercise for all three supplement conditions

  • Feelings of fatigue

    Baseline, 30-minutes post-ingestion of supplement, and at the 30-minute time point of exercise for all three supplement conditions

  • Feelings of energy

    Baseline, 30-minutes post-ingestion of supplement, and at the 30-minute time point of exercise for all three supplement conditions

  • +4 more secondary outcomes

Study Arms (3)

Pre-Workout Condition

EXPERIMENTAL

This condition consisted of the ingestion of one serving of the pre-workout supplement.

Dietary Supplement: ENGN Shred

Caffeine Condition

EXPERIMENTAL

This condition consisted of the ingestion of 6 mg of caffeine per kg of body mass.

Dietary Supplement: Nutricost caffeine powder

Placebo condition

PLACEBO COMPARATOR

This condition consisted of the ingestion of a placebo.

Dietary Supplement: Crystal Light

Interventions

ENGN ShredDIETARY_SUPPLEMENT

ENGN Shred is a multi-ingredient pre-workout supplement.

Pre-Workout Condition
Nutricost caffeine powderDIETARY_SUPPLEMENT

Caffeine powder.

Caffeine Condition
Crystal LightDIETARY_SUPPLEMENT

Non-caloric Crystal Light matched for the pre-workout in terms of flavor and consistency.

Placebo condition

Eligibility Criteria

Age19 Years - 29 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsIdentify as male.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male

You may not qualify if:

  • history of medical or surgical events, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders;
  • use of any medications
  • use of nutritional supplements
  • habitual use of caffeine (≥1 caffeinated beverage per day)
  • participation in another clinical trial or investigation of another investigational product within 30 days prior to screening/enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Physiology Laboratory

DeKalb, Illinois, 60115, United States

Location

Study Officials

  • Clayton L Camic, PhD

    Northern Illinois University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 26, 2020

First Posted

September 4, 2020

Study Start

September 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

September 4, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)