- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05354999
Effects of Combinations of Performance-enhancing Supplements on Exercise Performance
August 11, 2022 updated by: Morten Hostrup, PhD
Effects of Different Combinations of Performance-enhancing Supplements on High Intensity Exercise Performance
The purpose of the study is to investigate the effect of combinations of creatine monohydrate, sodium bicarbonate and caffeine on exercise performance and fatigability.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- August Krogh Building
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy
- VO2max of >50 ml/min/kg for men and >45 ml/min/kg for women
- Performs endurance training >3 times per week
Exclusion Criteria:
- Chronic disease deemed by the study responsible medical doctor to interfere with any part of the study
- Smoking
- Chronic use of prescription medicine deemed by the study responsible medical doctor to interfere with any part of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Creatine
Subjects ingest creatine monohydrate daily.
|
On experimental days subjects ingest a combination of sodium bicarbonate, caffeine and placebo.
|
Placebo Comparator: Placebo
Subjects ingest placebo daily.
|
On experimental days subjects ingest a combination of sodium bicarbonate, caffeine and placebo.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Work performed (kJ/Watt)
Time Frame: Measured at each trial throughout the study, on average 4 weeks
|
Work performed during a 6 minute time trial
|
Measured at each trial throughout the study, on average 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Work performed (kJ/Watt)
Time Frame: Measured at each trial throughout the study, on average 4 weeks
|
Work performed during a 15 second sprint test
|
Measured at each trial throughout the study, on average 4 weeks
|
Muscle strength (Nm)
Time Frame: Measured at each trial throughout the study, on average 4 weeks
|
Maximal voluntary isometric contraction of m. quadriceps femoris
|
Measured at each trial throughout the study, on average 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 18, 2022
Primary Completion (Anticipated)
March 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
April 18, 2022
First Submitted That Met QC Criteria
April 25, 2022
First Posted (Actual)
May 2, 2022
Study Record Updates
Last Update Posted (Actual)
August 12, 2022
Last Update Submitted That Met QC Criteria
August 11, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COCKTAIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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