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SarcopeniaPhase 2NCT03530202

Effects of High-velocity Resistance Training and Creatine Supplementation in Healthy Aging Males

A Phase 2 study testing Creatine monohydrate and Maltodextrin Powder in people with Sarcopenia, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The age-related loss of skeletal muscle mass (i.e. sarcopenia)and muscle performance (i.e. strength and power), decreases functionality and the ability to perform activities of daily living. Therefore, lifestyle interventions which may improve aging muscle health are important (i.e. Read more about this study

Who is it for?
Ages 50 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Sarcopenia
What is being tested?
Creatine monohydrate and Maltodextrin Powder
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteCanada
Study dates
1 Jan 2018to 31 Jul 2018
Phase
Phase 2
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 50 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Males (≥ 50 years) who are not engaged in supervised resistance training for ≥ 6 weeks prior to the start of the study will be recruited to participate.

Who cannot join

  • Participants will be excluded if they have taken medications that affect muscle biology or creatine monohydrate ≤ 12 weeks prior to the start of the study
  • If they have a history of fragility fractures; diseases that are known to affect muscle biology (i.e. corticoids)
  • If they suffer from severe osteoarthritis
  • If they are currently participating in moderate-vigorous resistance training (≥ 3 times per week)
  • If they are vegetarian
  • If they are planning to travel during the study period for greater than 2 weeks duration at a time.
  • Participants with kidney or liver abnormalities will be excluded.

Trial locations and contacts

1 site in 1 country.

Darren G Candow, PhD contact

(306) 585-4906

Darren.Candow@uregina.ca

Canada1 site, 1 recruiting
  • University of Regina

    Regina, Saskatchewan, S4S4J5

    Darren G Candow, PhD

    Darren G Candow, PhD

    Recruiting

Other trials in Canada

About this study

Official title: The Effect of High-velocity Resistance Training (HVRT) and Creatine Supplementation in Healthy Aging Males

The age-related loss of skeletal muscle mass (i.e. sarcopenia)and muscle performance (i.e. strength and power), decreases functionality and the ability to perform activities of daily living. Therefore, lifestyle interventions which may improve aging muscle health are important (i.e. resistance training and creatine supplementation). High-velocity resistance training (HVRT) has been shown to increase muscle mass and muscle performance in aging adults. Creatine (CR), a compound naturally found in red meat and seafood, has also been shown to increase muscle mass and muscle performance in aging adults. No study has examined the combined effects of HVRT and CR supplementation in aging adults. This study may determine whether this lifestyle intervention is effective to combat sarcopenia.

Read the detailed description

Purpose and hypothesis: The purpose of this thesis is to compare the effects of HVRT and CR supplementation to HVRT and placebo in healthy aging males. It is hypothesized that HVRT and CR supplementation will increase muscle mass, strength, power and tasks of functionality compared to HVRT and placebo.

Participants: An a priori power analysis (G*Power v. 3.1.5.1) indicated that 34 participants are required. This is based on a moderate effect size (Cohen's d = 0.25), an alpha level of .05, a ß-value of 0.8 for a repeated measures, within-between analysis of variance (ANOVA) design. Males (≥ 50 years) who are not engaged in resistance training for ≥ 6 weeks prior to the start of the study will be recruited. Participants will be informed of the risks and purposes of the study before written consent is obtained. The study will be approved by the Research Ethics Board at the University of Regina.

Methods and Research Design: The study will be a double-blind, repeated measures design. Participants will be randomized on a 1:1 basis to one of two groups: HVRT and CR or HVRT and placebo. The CR dosage will be 0.1g/kg/day as this dosage is effective for increasing muscle mass in aging males without resulting in adverse effects. On training days, participants will consume their supplement immediately after each training session mixed in water, juice or milk as post-exercise CR ingestion enhances its uptake into muscle and promotes increased muscle mass.

High-velocity Resistance Training Program: Participants will perform 3 sets of repetitions at 80% baseline 1-repetition maximum (1-RM) for the leg press, leg extension, leg curl, chest press, biceps curl, and triceps extension 2 times per week, for 8 weeks. Participants will perform the concentric phase of each muscle contraction as quickly as possible and will take 2 seconds to perform the eccentric phase.

Primary Dependent Variables

  1. Muscle thickness: Muscle thickness will be assessed by B-mode ultrasound (LOGIQ e, GE Medical Systems) on knee flexors, knee extensors, elbow flexors, and elbow extensors in the Aging Muscle and Bone Health Laboratory, University of Regina.
  2. Muscle strength: Leg press and chest press strength will be assessed using a 1-RM testing procedure in the Aging Muscle and Bone Health Laboratory, University of Regina.
  3. Muscle power: Torque (Nm) and power (watts) will be measured for the knee flexors and extensors using an isokinetic dynamometer (Biodex System 3, Biodex Medical Systems Inc.).
  4. Functionality tests: Dynamic balance will be measured as the time taken to perform backwards tandem walking over a distance of 6m on a 10cm-wide board that is raised about 4cm off the ground. Walking speed will be assessed by the time needed to walk an 80 m course.

Statistical Analyses: A 2 (group: CR vs. placebo) x 2 (time: pre- vs. post-training) repeated measures ANOVA will be used to determine differences between groups over time for the dependent variables. A one-factor ANOVA will be used to assess baseline characteristics and total training volume between groups. Significance will be set at an alpha level of 0.05 and all results will be expressed as means ± standard deviation. The magnitude of the difference between significant means will be determined by eta squared (η2). Statistical analyses will be performed using IBM SPSS Statistics, v. 24.

Conditions
Sarcopenia
Being tested
Creatine monohydrate, Maltodextrin Powder
Keywords
muscle thickness, strength, power, functionality
Medical subject headings
Sarcopenia

What participants receive

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

  • Creatine monohydrateDrug

    Also called Creapure, AlzChem AG, Trostberg, Germany

    Participants will consume creatine monohydrate powder (Creapure, AlzChem AG, Trostberg, Germany) every day for 8 weeks. On training days participants will consume supplement immediately after each training session (~ 5 minutes) mixed in water as post-exercise creatine ingestion enhances its uptake into muscle and promotes increased muscle mass. On non-training days, supplements will be consumed at the participant's leisure.

  • Maltodextrin PowderDrug

    Also called Globe Plus 10 DE Maltodextrin, Univar, Canada

    Participants will consume Maltodextrin Powder (Globe Plus 10 DE Maltodextrin Powder, Univar Canada) every day for 8 weeks. On training days participants will consume supplement immediately after each training session (~ 5 minutes) mixed in water. On non-training days, supplements will be consumed at the participant's leisure.

Study groups in NCT03530202
Study groupRoleWhat they receive
HVRT + Creatine MonohydrateExperimentalParticipants will perform 8-weeks of high-velocity resistance training, defined as performing the concentric phase of a lift as fast as possible and taking two seconds to perform the eccentric phase of the lift, on six exercises (bilateral legpress, leg extension, leg curl, chest press, triceps extension, and biceps curl) and consume creatine monohydrate powder. The load will be 80% of the participants one-repetition max (1RM; the maximum weight that can be successfully lifted one time with proper form).
Receives: Drug: Creatine monohydrate
HVRT + Maltodextrin PowderPlacebo comparatorParticipants will perform 8-weeks of high-velocity resistance training, defined as performing the concentric phase of a lift as fast as possible and taking two seconds to perform the eccentric phase of the lift, on six exercises (bilateral legpress, leg extension, leg curl, chest press, triceps extension, and biceps curl) and consume maltodexterin powder. The load will be 80% of the participants one-repetition max (1RM; the maximum weight that can be successfully lifted one time with proper form).
Receives: Drug: Maltodextrin Powder

What is being measured

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

  1. Change in muscle thickness

    Muscle thickness (right side) of the elbow flexors, elbow extensors, knee flexors, and knee extensors will be measured using B-Mode ultrasound (LOGIQ e, GE Medical Systems).

    Measured: Baseline and again once intervention is completed (8 weeks)

Secondary outcomes (5)
  1. Change in muscle strength

    Leg press and chest press strength will be assessed using a 1-repetition maximum (1-RM) standard testing procedure in the Aging Muscle and Bone Health Laboratory, University of Regina.

    Measured: Baseline and again once intervention is completed (8 weeks)

  2. Change in peak torque (Nm)

    Peak torque (Nm) will be measured for the knee flexors and extensors using an isokinetic dynamometer (Biodex System 3, Biodex Medical Systems Inc.).

    Measured: Baseline and again once intervention is completed (8 weeks)

  3. Change peak muscle power (watts)

    Peak muscle power (watts) will be measured for the knee flexors and extensors using an isokinetic dynamometer (Biodex System 3, Biodex Medical Systems Inc.).

    Measured: Baseline and again once intervention is completed (8 weeks)

  4. Change in dynamic balance

    Dynamic balance will be measured as the time taken to perform backwards tandem walking (i.e. toe to heel) over a distance of 6m on a 10cm-wide board that is raised about 4cm off the ground.

    Measured: Baseline and again once intervention is completed (8 weeks)

  5. Walking speed

    Walking speed will be assessed by the time needed to walk an 80 m course at a fast pace.

    Measured: Baseline and again once intervention is completed (8 weeks)

Timeline

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

  1. First posted21 May 2018
  2. Study start1 Jan 2018
  3. Primary completion31 Jul 2018 (estimated)
  4. Study completion31 Jul 2018 (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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will be a double-blind, repeated measures design. Participants will be randomized on a 1:1 basis to one of two groups: high-velocity resistance training and creatine or high-velocity resistance training and placebo.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03530202
Sponsor's protocol ID
URegina
Status last verified
May 2018
First submitted
19 Apr 2018
Last updated
21 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PubMed 17695343
  • Candow DG, Little JP, Chilibeck PD, Abeysekara S, Zello GA, Kazachkov M, Cornish SM, Yu PH. Low-dose creatine combined with protein during resistance training in older men. Med Sci Sports Exerc. 2008 Sep;40(9):1645-52. doi: 10.1249/MSS.0b013e318176b310.

    PubMed 18685526
  • Chilibeck PD, Stride D, Farthing JP, Burke DG. Effect of creatine ingestion after exercise on muscle thickness in males and females. Med Sci Sports Exerc. 2004 Oct;36(10):1781-8. doi: 10.1249/01.mss.0000142301.70419.c6.

    PubMed 15595301
  • Harris RC, Soderlund K, Hultman E. Elevation of creatine in resting and exercised muscle of normal subjects by creatine supplementation. Clin Sci (Lond). 1992 Sep;83(3):367-74. doi: 10.1042/cs0830367.

    PubMed 1327657
  • Nogueira W, Gentil P, Mello SN, Oliveira RJ, Bezerra AJ, Bottaro M. Effects of power training on muscle thickness of older men. Int J Sports Med. 2009 Mar;30(3):200-4. doi: 10.1055/s-0028-1104584. Epub 2009 Feb 6.

    PubMed 19199198

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Creatine monohydrate and Maltodextrin Powder in people with Sarcopenia, 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 1 inclusion and 7 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 21 May 2018. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 ((306) 585-4906, Darren.Candow@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in muscle thickness (time frame: Baseline and again once intervention is completed (8 weeks)). 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 NCT03530202, which also lists 5 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 21 May 2018.

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