search
Back to results

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

Primary Purpose

Sarcopenia

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Creatine monohydrate
Maltodextrin Powder
Sponsored by
University of Regina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring muscle thickness, strength, power, functionality

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of ReginaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HVRT + Creatine Monohydrate

HVRT + Maltodextrin Powder

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
April 19, 2018
Last Updated
May 18, 2018
Sponsor
University of Regina
search

1. Study Identification

Unique Protocol Identification Number
NCT03530202
Brief Title
Effects of High-velocity Resistance Training and Creatine Supplementation in Healthy Aging Males
Official Title
The Effect of High-velocity Resistance Training (HVRT) and Creatine Supplementation in Healthy Aging Males
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Anticipated)
Study Completion Date
July 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Regina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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 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. 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. 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.). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
muscle thickness, strength, power, functionality

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
A research assistant who is not involved in the study in any other way will be responsible for randomization.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HVRT + Creatine Monohydrate
Arm Type
Experimental
Arm Description
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).
Arm Title
HVRT + Maltodextrin Powder
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Creatine monohydrate
Other Intervention Name(s)
Creapure, AlzChem AG, Trostberg, Germany
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Maltodextrin Powder
Other Intervention Name(s)
Globe Plus 10 DE Maltodextrin, Univar, Canada
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in muscle thickness
Description
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).
Time Frame
Baseline and again once intervention is completed (8 weeks)
Secondary Outcome Measure Information:
Title
Change in muscle strength
Description
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.
Time Frame
Baseline and again once intervention is completed (8 weeks)
Title
Change in peak torque (Nm)
Description
Peak torque (Nm) will be measured for the knee flexors and extensors using an isokinetic dynamometer (Biodex System 3, Biodex Medical Systems Inc.).
Time Frame
Baseline and again once intervention is completed (8 weeks)
Title
Change peak muscle power (watts)
Description
Peak muscle power (watts) will be measured for the knee flexors and extensors using an isokinetic dynamometer (Biodex System 3, Biodex Medical Systems Inc.).
Time Frame
Baseline and again once intervention is completed (8 weeks)
Title
Change in dynamic balance
Description
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.
Time Frame
Baseline and again once intervention is completed (8 weeks)
Title
Walking speed
Description
Walking speed will be assessed by the time needed to walk an 80 m course at a fast pace.
Time Frame
Baseline and again once intervention is completed (8 weeks)

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
The 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.
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Darren G Candow, PhD
Phone
(306) 585-4906
Email
Darren.Candow@uregina.ca
First Name & Middle Initial & Last Name or Official Title & Degree
John P Neary, PhD
Phone
(306) 585-4844
Email
Patrick.Neary@uregina.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darren G Candow, PhD
Organizational Affiliation
Professor, Associate Dean of Graduate Studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regina
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S4J5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darren G Candow, PhD
First Name & Middle Initial & Last Name & Degree
Darren G Candow, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17695343
Citation
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.
Results Reference
background
PubMed Identifier
18685526
Citation
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.
Results Reference
background
PubMed Identifier
15595301
Citation
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.
Results Reference
background
PubMed Identifier
1327657
Citation
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.
Results Reference
background
PubMed Identifier
19199198
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs