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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04290819
Other study ID # 2018-251
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 15, 2019
Est. completion date September 1, 2020

Study information

Verified date February 2020
Source University of Regina
Contact Darren G Candow, PhD
Phone 209-0280
Email darren.candow@uregina.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date September 1, 2020
Est. primary completion date May 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria:

- Male or Female ages 18-39

- Resistance training for minimum of 6 months 3/week.

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms

  • Performance Enhancing Product Use

Intervention

Dietary Supplement:
Creatine Monohydrate
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 Caffeine
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.
Caffeine
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.
Placebo
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.

Locations

Country Name City State
Canada University of Regina Regina Saskatchewan

Sponsors (1)

Lead Sponsor Collaborator
University of Regina

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Graham TE. Caffeine and exercise: metabolism, endurance and performance. Sports Med. 2001;31(11):785-807. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Trexler ET, Smith-Ryan AE. Creatine and Caffeine: Considerations for Concurrent Supplementation. Int J Sport Nutr Exerc Metab. 2015 Dec;25(6):607-23. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle strength using a standard plate loaded leg press and chest press machine 1-Rep max for leg press and chest press. 6 weeks
Primary Hypertrophy Ultrasound of biceps, triceps, quads and hamstrings. Size in cm of each muscle site. 6 weeks
Primary Muscle endurance using a standard plate loaded leg press and chest press machine Reps to fatigue at 50% 1-Rep Max. 6 weeks
Primary 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 Fatigue Scale (Generic) Assessed using fatigue scale (1-10) after each workout. The higher the number, the more the participant is fatigued 6 weeks
Secondary 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. 6 weeks
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