NCT03530202

Brief 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. 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.

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
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_2

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

January 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

April 19, 2018

Last Update Submit

May 18, 2018

Conditions

Keywords

muscle thicknessstrengthpowerfunctionality

Outcome Measures

Primary Outcomes (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).

    Baseline and again once intervention is completed (8 weeks)

Secondary Outcomes (5)

  • Change in muscle strength

    Baseline and again once intervention is completed (8 weeks)

  • Change in peak torque (Nm)

    Baseline and again once intervention is completed (8 weeks)

  • Change peak muscle power (watts)

    Baseline and again once intervention is completed (8 weeks)

  • Change in dynamic balance

    Baseline and again once intervention is completed (8 weeks)

  • Walking speed

    Baseline and again once intervention is completed (8 weeks)

Study Arms (2)

HVRT + Creatine Monohydrate

EXPERIMENTAL

Participants 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).

Drug: Creatine monohydrate

HVRT + Maltodextrin Powder

PLACEBO COMPARATOR

Participants 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).

Drug: Maltodextrin Powder

Interventions

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.

Also known as: Creapure, AlzChem AG, Trostberg, Germany
HVRT + Creatine Monohydrate

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.

Also known as: Globe Plus 10 DE Maltodextrin, Univar, Canada
HVRT + Maltodextrin Powder

Eligibility Criteria

Age50 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThe response to creatine supplementation is inconsistent between males and females. Females may not experience the same gains in muscle mass and strength following creatine supplementation and resistance training compared to males. Although speculative, females may have higher initial intramuscular creatine stores than males which make them less responsive to supplementation. Furthermore, creatine appears to have no effect on muscle protein kinetics in females. Therefore, for the purpose of this study, only healthy aging males will be recruited.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Regina

Regina, Saskatchewan, S4S4J5, Canada

RECRUITING

Related Publications (5)

  • 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.

    PMID: 17695343BACKGROUND
  • 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.

    PMID: 18685526BACKGROUND
  • 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.

    PMID: 15595301BACKGROUND
  • 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.

    PMID: 1327657BACKGROUND
  • 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.

    PMID: 19199198BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Interventions

Creatine

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Darren G Candow, PhD

    Professor, Associate Dean of Graduate Studies

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Darren G Candow, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
A research assistant who is not involved in the study in any other way will be responsible for randomization.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2018

First Posted

May 21, 2018

Study Start

January 1, 2018

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

May 21, 2018

Record last verified: 2018-05

Locations