NCT02255201

Brief Summary

The purpose of this study is to determine the effects of four different pre-workout beverages as compared to placebo on muscular strength and endurance, perceived energy and cognitive performance in healthy adult males.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

3 months

First QC Date

September 26, 2014

Last Update Submit

April 6, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Change in Muscular Strength and Endurance compared to Placebo

    Muscular Strength and Endurance will be measured by Bench Press and Leg Press 1-RM and repetitions to exhaustion.

    One day

Secondary Outcomes (1)

  • Change from Baseline in Cognitive Performance

    Baseline to one-hour post dose and immediately post exercise

Other Outcomes (1)

  • Change from Baseline in Perceived Energy and Fatigue

    Baseline to one-hour post dose and immediately post exercise

Study Arms (5)

Beverage A

ACTIVE COMPARATOR

Single dose, Pre-Workout Master Performance Blend Dose 1

Dietary Supplement: Master Performance Blend Dose 1

Beverage B

ACTIVE COMPARATOR

Single dose, Pre-Workout Master Performance Blend Dose 2

Dietary Supplement: Master Performance Blend Dose 2

Beverage C

ACTIVE COMPARATOR

Single dose, Pre-Workout Performance Energy Blend

Dietary Supplement: Performance Energy Blend

Beverage D

ACTIVE COMPARATOR

Single dose, Pre-Workout Energy Blend

Dietary Supplement: Energy Blend

Beverage E

PLACEBO COMPARATOR

Single dose, Pre-Workout Placebo

Dietary Supplement: Placebo

Interventions

Master Performance Blend Dose 1DIETARY_SUPPLEMENT

Caffeine content: 200 mg

Beverage A
Master Performance Blend Dose 2DIETARY_SUPPLEMENT

Caffeine content: 400 mg

Beverage B
Performance Energy BlendDIETARY_SUPPLEMENT

Caffeine content: 175 mg

Beverage C
Energy BlendDIETARY_SUPPLEMENT

Caffeine content: 200 mg

Beverage D
PlaceboDIETARY_SUPPLEMENT

Caffeine content: 0 mg

Beverage E

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males, aged 18 to 40 years
  • Subject has a waist circumference ≤ 97 cm.
  • Subject is a non-smoker.
  • Subject is in good health and appropriate for exercise as determined by physical examination, medical history and ECG.
  • Subject is weight training for the 6 months prior to starting the trial.
  • Subject agrees to not use any new vitamins and/or minerals until after study completion and to not take any vitamins and/or minerals 24 hours prior to the test visits.
  • Subject is willing and able to comply with the protocol including:
  • Attending 5 visits each of which is approximately 4 hours long;
  • Refraining from caffeine, over-the-counter medications and alcohol for the 24 hours prior to the test visits;
  • Refraining from weight training for the 48 hours prior and refraining from any exercise other than weight training for 24 hours prior to the test visits;
  • Refraining from taking any dietary or herbal supplements throughout the study.
  • Subject is able to understand and sign the informed consent to participate in the study.

You may not qualify if:

  • Subject has any of the following medical conditions:
  • active heart disease
  • uncontrolled high blood pressure (≥ 140/90 mmHg)
  • renal or hepatic impairment/disease
  • Type I or II diabetes
  • bipolar disorder
  • pulmonary disease (including current asthma)
  • Parkinson's disease
  • Seizure disorder
  • unstable thyroid disease
  • immune disorder (such as HIV/AIDS)
  • active psychiatric disorders (including anxiety disorders)
  • bleeding disorders
  • gastrointestinal ulcer disease
  • Subject has any orthopedic problem(s) or history of musculoskeletal injury(ies) which make(s) resistance weight training contraindicated.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miami Research Associates

Miami, Florida, 33143, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2014

First Posted

October 2, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

US(1)