NCT05354999

Brief Summary

The purpose of the study is to investigate the effect of combinations of creatine monohydrate, sodium bicarbonate and caffeine on exercise performance and fatigability.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
23

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

April 18, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

April 18, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 12, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

April 18, 2022

Last Update Submit

August 11, 2022

Conditions

Healthy

Keywords

ExercisePerformanceSupplementation

Outcome Measures

Primary Outcomes (1)

  • Work performed (kJ/Watt)

    Work performed during a 6 minute time trial

    Measured at each trial throughout the study, on average 4 weeks

Secondary Outcomes (2)

  • Work performed (kJ/Watt)

    Measured at each trial throughout the study, on average 4 weeks

  • Muscle strength (Nm)

    Measured at each trial throughout the study, on average 4 weeks

Study Arms (2)

Creatine

EXPERIMENTAL

Subjects ingest creatine monohydrate daily.

Dietary Supplement: Sodium bicarbonate and caffeine

Placebo

PLACEBO COMPARATOR

Subjects ingest placebo daily.

Dietary Supplement: Sodium bicarbonate and caffeine

Interventions

Sodium bicarbonate and caffeineDIETARY_SUPPLEMENT

On experimental days subjects ingest a combination of sodium bicarbonate, caffeine and placebo.

CreatinePlacebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • VO2max of \>50 ml/min/kg for men and \>45 ml/min/kg for women
  • Performs endurance training \>3 times per week

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

August Krogh Building

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Sodium BicarbonateCaffeine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsXanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 18, 2022

First Posted

May 2, 2022

Study Start

April 18, 2022

Primary Completion

March 1, 2023

Study Completion

December 1, 2023

Last Updated

August 12, 2022

Record last verified: 2022-08

Locations

DK(1)