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Performance Enhancing Product UseNCT04290819

Effect of Creatine and Caffeine on Muscle Performance

A study testing Creatine Monohydrate, Creatine Monohydrate and Caffeine and Caffeine in people with Performance Enhancing Product Use, run by University of Regina at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To determine if creatine and caffeine can be co-supplemented without inhibiting the effects of creatine. Read more about this study

Who is it for?
Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for
Performance Enhancing Product Use
What is being tested?
Creatine Monohydrate, Creatine Monohydrate and Caffeine and Caffeine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteCanada
Study dates
15 Feb 2019to 1 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Darren G Candow, PhD contact

209-0280 ext. 306

darren.candow@uregina.ca

Avery R Pakulak, BKin contact

216-2904 ext. 306

pakulaka@uregina.ca

Canada1 site, 1 recruiting
  • University of Regina

    Regina, Saskatchewan, S4S4H4

    Darren G Candow, PhD, 3062090280, Darren.Candow@uregina.ca

    Darren G Candow, PhD

    Recruiting

Other trials in Canada

About this study

Official title: Effects of Creatine and Caffeine Co-Supplementation on Muscle Mass and Muscle Performance in Trained Young Adults

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

Read the detailed description

Creatine and caffeine are among the most popular ergogenic aids used by exercising individuals. Creatine supplementation during resistance training has been shown to increase muscle mass and muscle performance (i.e. strength, endurance), possibly by influencing high-energy phosphate metabolism, muscle protein kinetics, and inflammation. Caffeine ingestion has been shown to increase muscle performance, primarily by influencing adenosine receptor activity, muscle protein kinetics, phosphodiesterase, and excitation-coupling. Previous research investigating the combined effects of creatine and caffeine has produced mixed results, with some showing a beneficial effect on short-term anaerobic type activities, while other report no effect. Despite the potential beneficial effects of creatine and caffeine separately, no study has compared the combined effects of creatine and caffeine during resistance training. Therefore, the purpose of this thesis is to determine the effects of creatine and caffeine co-supplementation during resistance training on muscle mass and muscle performance in trained young adults.

The study will be a double-blind, repeated measures design. In order to minimize group differences, participants will be matched according to age and weight and be randomized on a 1:1:1:1 basis to one of four groups: Creatine + Caffeine (CR-CAF; 0.1 g/kg of creatine monohydrate powder + 3 mg/kg of caffeine [micronized powder]); Creatine (CR; 0.1 g/kg of creatine monohydrate powder + 3 mg/kg of caffeine placebo [micronized cellulose powder]), Caffeine (CAF; 3 mg/kg of caffeine + 0.1 g/kg of creatine monohydrate placebo [maltodextrin]) or placebo (PLA; 0.1g/kg creatine monohydrate placebo + 3 mg/kg of caffeine placebo). An individual, blinded to supplement and group allocation, will be responsible for the preparation of study kits. Each study kit will contain the participants supplement for the duration of the study, detailed supplementation instructions, measuring spoons, supplementation compliance log, daily caffeine consumption log and a resistance training log. Supplement powders will be similar in energy content, color, taste, texture, and appearance. The creatine dosage of 0.1 g/kg has previously been shown to be effective for increasing muscle mass and muscle performance. The caffeine dosage of 3 mg/kg has been shown to increase muscle performance. Participants will be instructed to refrain from additional caffeine sources ≥ 3 hour prior to consuming their supplement so that a valid estimate regarding the effects of caffeine supplementation on muscle can be made. On training days, participants will mix their supplement powder in water and consume the solution 60 minutes prior to exercise. Sixty minutes was chosen because this is the approximate time it takes for peak plasma caffeine concentrations to occur after caffeine ingestion and pre-exercise creatine supplementation has a beneficial effect on muscle performance.

Participants will follow the same periodized, resistance training program for 6 weeks. The program will consist of three sets of 6, 8, 10 repetitions to muscle fatigue in order. Resistance training will start on the first day of supplementation and will consist of a split routine involving whole body musculature. Day 1 will involve chest and biceps musculature and include the following exercises in order: machine-based chest press, free weight incline bench press or dumbbell press, free-weight flat dumbbell press, machine-based pec-dec, free-weight standing barbell curl, free-weight alternate arm dumbbell curl and machine-based preacher curl. Day 2 will involve leg and core musculature and include the following exercises in order: free-weight squat, machine-based leg press, machine-based leg extension, machine-based leg curl, machine-based calf raise, and machine-based weighted abdominal crunches. Day 3 will serve as a rest day from training. Day 4 will involve back and triceps musculature and include the following exercises in order: body weight or weight-assisted chin-ups, machine-based seated row, machine-based lat pull-down, free-weight alternate dumb-bell row, free-weight close-grip bench press, machine-based cable triceps bar extension, and machine-based cable triceps rope extension. Day 5 will involve shoulder and core musculature and include the following exercises in order: free-weight dumbbell press, free-weight upright row, free-weight shrugs, free-weight or machine based lateral deltoid flys, free weight or machine-based rear deltoid flys and machine-based weighted abdominal crunches. Day 6 will serve as a rest day from training. This cycle will be repeated for 6 weeks. Participants will maintain training logs to ensure adherence and compliance to the study and to determine total training volume (load x repetitions x sets).

Being tested
Creatine Monohydrate, Creatine Monohydrate and Caffeine, Caffeine, Placebo
Keywords
Muscle Endurance, Strength, Hypertrophy, Resistance Training, Creatine, Caffeine
Medical subject headings
Hypertrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

  • 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.

  • 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.

Study groups in NCT04290819
Study groupRoleWhat they receive
Resistance Training with Creatine MonohydrateExperimentalParticipants 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.
Receives: Dietary Supplement: Creatine Monohydrate
Resistance Training with CaffeineExperimentalParticipants 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.
Receives: Dietary Supplement: Caffeine
Resistance Training with Caffeine and Creatine MonohydrateExperimentalParticipants 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.
Receives: Dietary Supplement: Creatine Monohydrate and Caffeine
Resistance Training with PlaceboPlacebo comparatorParticipants 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.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    1-Rep max for leg press and chest press.

    Measured: 6 weeks

  2. Hypertrophy

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

    Measured: 6 weeks

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

    Reps to fatigue at 50% 1-Rep Max.

    Measured: 6 weeks

  4. 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.

    Measured: 6 weeks

Secondary outcomes (2)
  1. Fatigue Scale (Generic)

    Assessed using fatigue scale (1-10) after each workout. The higher the number, the more the participant is fatigued

    Measured: 6 weeks

  2. Rating of perceived exertion (Generic)

    Modified to encompass entire training day. 1-10 scale as to how hard that particular workout was. The higher the number, the harder the workout felt to the participant.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study start15 Feb 2019
  3. Primary completion31 May 2020 (estimated)
  4. Study completion1 Sep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Factorial
Model description
4 groups. Comparing each group against one another. Creatine vs. Caffeine vs. Caffeine and Creatine vs. Placebo
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04290819
Sponsor's protocol ID
2018-251
Status last verified
Feb 2020
First submitted
8 Jan 2020
Last updated
2 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: As of now there is no plan to share data of individual participants.

Publications

  • 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.

    PubMed 26219105
  • 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.

    PubMed 18347671
  • 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.

    PubMed 29138605
  • 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.

    PubMed 29087785
  • 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.

    PubMed 28615996
  • 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.

    PubMed 24190049
  • Graham TE. Caffeine and exercise: metabolism, endurance and performance. Sports Med. 2001;31(11):785-807. doi: 10.2165/00007256-200131110-00002.

    PubMed 11583104
  • 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.

    PubMed 27108136

Questions about this trial

What is this clinical trial studying?

A study testing Creatine Monohydrate, Creatine Monohydrate and Caffeine and Caffeine in people with Performance Enhancing Product Use, run by University of Regina at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Darren G Candow, PhD (209-0280 ext. 306, darren.candow@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle strength using a standard plate loaded leg press and chest press machine (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04290819, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.

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