NCT04290819

Brief Summary

To determine if creatine and caffeine can be co-supplemented without inhibiting the effects of creatine.

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
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

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

Study Start

First participant enrolled

February 15, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

January 8, 2020

Last Update Submit

February 26, 2020

Conditions

Performance Enhancing Product Use

Keywords

Muscle EnduranceStrengthHypertrophyResistance TrainingCreatineCaffeine

Outcome Measures

Primary Outcomes (4)

  • Muscle strength using a standard plate loaded leg press and chest press machine

    1-Rep max for leg press and chest press.

    6 weeks

  • Hypertrophy

    Ultrasound of biceps, triceps, quads and hamstrings. Size in cm of each muscle site.

    6 weeks

  • Muscle endurance using a standard plate loaded leg press and chest press machine

    Reps to fatigue at 50% 1-Rep Max.

    6 weeks

  • Body Composition using a Bod Pod

    Test used to determine fat mass and lean tissue within a subject. Gives the fat % and the remainder is considered everything else. Since bone and organ wont really change over 6 weeks, all changes are considered to be lean tissue changes.

    6 weeks

Secondary Outcomes (2)

  • Fatigue Scale (Generic)

    6 weeks

  • Rating of perceived exertion (Generic)

    6 weeks

Study Arms (4)

Resistance Training with Creatine Monohydrate

EXPERIMENTAL

Participants will go through a 6 week resistance training program (unsupervised), at the facility of their choice. They will be given a program to follow with a 2 day on one day rest split routine as follows: Chest and biceps, legs and core, rest, back and triceps, shoulders and core, rest. This cycle will repeat for the 6 week program.

Dietary Supplement: Creatine Monohydrate

Resistance Training with Caffeine

EXPERIMENTAL

Participants will go through a 6 week resistance training program (unsupervised), at the facility of their choice. They will be given a program to follow with a 2 day on one day rest split routine as follows: Chest and biceps, legs and core, rest, back and triceps, shoulders and core, rest. This cycle will repeat for the 6 week program.

Dietary Supplement: Caffeine

Resistance Training with Caffeine and Creatine Monohydrate

EXPERIMENTAL

Participants will go through a 6 week resistance training program (unsupervised), at the facility of their choice. They will be given a program to follow with a 2 day on one day rest split routine as follows: Chest and biceps, legs and core, rest, back and triceps, shoulders and core, rest. This cycle will repeat for the 6 week program.

Dietary Supplement: Creatine Monohydrate and Caffeine

Resistance Training with Placebo

PLACEBO COMPARATOR

Participants will go through a 6 week resistance training program (unsupervised), at the facility of their choice. They will be given a program to follow with a 2 day on one day rest split routine as follows: Chest and biceps, legs and core, rest, back and triceps, shoulders and core, rest. This cycle will repeat for the 6 week program.

Dietary Supplement: Placebo

Interventions

Creatine MonohydrateDIETARY_SUPPLEMENT

0.1g/kg of body weight (pre measured creatine) and 3mg/kg of body weight (pre measured micronized cellulose powder-caffeine placebo) self administered 1 hr prior to working out mixed in water.

Resistance Training with Creatine Monohydrate
Creatine Monohydrate and CaffeineDIETARY_SUPPLEMENT

0.1g/kg body weight (pre measured creatine) and 3mg/kg body weight (pre measured caffeine) self administered 1hr prior to working out mixed in water.

Resistance Training with Caffeine and Creatine Monohydrate
CaffeineDIETARY_SUPPLEMENT

3mg/kg of body weight (pre measured caffeine) and 0.1g/kg of bodyweight (pre measured maltodextrin- creatine placebo) self administered 1 hr prior to working out mixed in water.

Resistance Training with Caffeine
PlaceboDIETARY_SUPPLEMENT

0.1g/kg of body weight (pre measured maltodextrin) and 3mg/kg of body weight (pre measured micronized cellulose powder) self administered 1 hr prior to working out mixed in water.

Resistance Training with Placebo

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or Female ages 18-39
  • Resistance training for minimum of 6 months 3/week.

You may not qualify if:

  • Creatine supplementation within last 3 months
  • Taking medications that affect muscle biology
  • Have a disease that affects muscle biology
  • Pre existing liver or kidney abnormalities
  • Plan to travel for greater then 1 week during the study where you have NO access to fitness facility.
  • Fail Par-Q and are unable to receive doctors clearance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Regina

Regina, Saskatchewan, S4S4H4, Canada

RECRUITING

Related Publications (8)

  • Trexler ET, Smith-Ryan AE. Creatine and Caffeine: Considerations for Concurrent Supplementation. Int J Sport Nutr Exerc Metab. 2015 Dec;25(6):607-23. doi: 10.1123/ijsnem.2014-0193.

    PMID: 26219105BACKGROUND

  • Candow DG, Chilibeck PD. Timing of creatine or protein supplementation and resistance training in the elderly. Appl Physiol Nutr Metab. 2008 Feb;33(1):184-90. doi: 10.1139/H07-139.

    PMID: 18347671BACKGROUND

  • Chilibeck PD, Kaviani M, Candow DG, Zello GA. Effect of creatine supplementation during resistance training on lean tissue mass and muscular strength in older adults: a meta-analysis. Open Access J Sports Med. 2017 Nov 2;8:213-226. doi: 10.2147/OAJSM.S123529. eCollection 2017.

    PMID: 29138605BACKGROUND

  • Grgic J. Caffeine ingestion enhances Wingate performance: a meta-analysis. Eur J Sport Sci. 2018 Mar;18(2):219-225. doi: 10.1080/17461391.2017.1394371. Epub 2017 Oct 31.

    PMID: 29087785BACKGROUND

  • Kreider RB, Kalman DS, Antonio J, Ziegenfuss TN, Wildman R, Collins R, Candow DG, Kleiner SM, Almada AL, Lopez HL. International Society of Sports Nutrition position stand: safety and efficacy of creatine supplementation in exercise, sport, and medicine. J Int Soc Sports Nutr. 2017 Jun 13;14:18. doi: 10.1186/s12970-017-0173-z. eCollection 2017.

    PMID: 28615996BACKGROUND

  • Candow DG, Chilibeck PD, Forbes SC. Creatine supplementation and aging musculoskeletal health. Endocrine. 2014 Apr;45(3):354-61. doi: 10.1007/s12020-013-0070-4. Epub 2013 Nov 5.

    PMID: 24190049BACKGROUND

  • Graham TE. Caffeine and exercise: metabolism, endurance and performance. Sports Med. 2001;31(11):785-807. doi: 10.2165/00007256-200131110-00002.

    PMID: 11583104BACKGROUND

  • Gualano B, Rawson ES, Candow DG, Chilibeck PD. Creatine supplementation in the aging population: effects on skeletal muscle, bone and brain. Amino Acids. 2016 Aug;48(8):1793-805. doi: 10.1007/s00726-016-2239-7. Epub 2016 Apr 23.

    PMID: 27108136BACKGROUND

MeSH Terms

Conditions

Hypertrophy

Interventions

CreatineCaffeine

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsXanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Darren G Candow, PhD

    Assoicate Dean of Kinesiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Darren G Candow, PhD

CONTACT

209-0280darren.candow@uregina.ca

Avery R Pakulak, BKin

CONTACT

216-2904pakulaka@uregina.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind study
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Model Details: 4 groups. Comparing each group against one another. Creatine vs. Caffeine vs. Caffeine and Creatine vs. Placebo
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2020

First Posted

March 2, 2020

Study Start

February 15, 2019

Primary Completion

May 31, 2020

Study Completion

September 1, 2020

Last Updated

March 2, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

As of now there is no plan to share data of individual participants.

Locations

CA(1)