The Benefits of Hemp Protein Supplementation During Resistance Training
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hemp powder
Soy Powder
Sponsored by
About this trial
This is an interventional other trial for Sarcopenia
Eligibility Criteria
Inclusion Criteria:
- At least 6 months experience with resistance training
Exclusion Criteria:
- Allergies to hemp or soy
- Consumption of other nutritional supplements in previous month
- Answered "yes" to questions on the Physical Activity Readiness Questionnaire
Sites / Locations
- University of Saskatchewan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hemp powder
Soy powder
Arm Description
Hemp powder supplement
Soy powder supplement
Outcomes
Primary Outcome Measures
Change in lean tissue mass (kg)
Lean tissue mass measured with dual energy x-ray absrorptiometry
Secondary Outcome Measures
Change in fat mass (kg)
Fat mass as measured by dual energy x-ray absorptiometry
Change in bone mass (grams)
Bone mass as measured by dual energy x-ray absorptiometry
Change in elbow flexor muscle thickness (cm)
Muscle thickness as assessed by ultrasound
Change in knee extensor muscle thickness (cm)
muscle thickness as measured by ultrasound
Change in bench press strength (kg)
Bench press strength as assess on a plate-loaded machine by the 1-RM method
Change in arm curl strength (kg)
Arm curl strength as assessed with dumbbells by the 1-RM method
Change in leg press strength (kg)
Leg press strength as assessed on a leg-press machine by the 1-RM method
Change in inflammation by interleukin-6 (mmol/l) levels
Interleukin-6 levels measured from saliva samples
Change in inflammation by C-reactive protein (mmol/l) levels
C-reactive protein levels measured from saliva samples
Change in bone resorption (N-telopeptides) (mmol/l)
N-telopeptides measured from urine samples
Change in voluntary muscle activation (Nm)
Voluntary muscle activation as measured by the interpolated twitch technique
Full Information
NCT ID
NCT02529917
First Posted
August 11, 2015
Last Updated
May 2, 2017
Sponsor
University of Saskatchewan
1. Study Identification
Unique Protocol Identification Number
NCT02529917
Brief Title
The Benefits of Hemp Protein Supplementation During Resistance Training
Official Title
The Benefits of Hemp Protein Supplementation During Resistance Training
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Forty physically active men and women aged 18-45y will take part in an 8-week resistance training program, randomized (double blind) 1:1 into each of two groups. Twenty participants will be randomized to receive 60 g/d of hemp powder (containing approximately 40 g protein and 9 g oil) supplementation and 20 randomized to receive 60 g/d of soy supplementation (matched to the hemp for macronutrients and calories) during eight weeks of training. Each participant will complete testing before and after the intervention for assessment of body composition (lean tissue, fat, and bone mass), strength, central fatigue, markers of inflammation, and bone resorption. Over the 8-weeks of training, participants will train four-five days per week for 1-1.5 hours per session with exercises targeting all major muscle groups. The training will involve a "two day split" where different muscle groups are trained on two consecutive days (day 1 involves chest, back, and arms; day 2 legs, shoulders, and abdominals). Resistance training will provide the necessary stimulus for protein synthesis to optimize the effect of a protein-containing nutritional supplement. The hemp or soy powder will be consumed in two doses (i.e. 30 g powder containing 20 g protein per dose) immediately after exercise sessions and one hour after exercise. This dosing regimen is optimal for stimulating muscle protein synthesis and building muscle mass . On the one non-training day per week the two doses will be consumed with meals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hemp powder
Arm Type
Experimental
Arm Description
Hemp powder supplement
Arm Title
Soy powder
Arm Type
Active Comparator
Arm Description
Soy powder supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Hemp powder
Intervention Description
Hemp powder supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy Powder
Intervention Description
Soy powder supplement
Primary Outcome Measure Information:
Title
Change in lean tissue mass (kg)
Description
Lean tissue mass measured with dual energy x-ray absrorptiometry
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in fat mass (kg)
Description
Fat mass as measured by dual energy x-ray absorptiometry
Time Frame
8 weeks
Title
Change in bone mass (grams)
Description
Bone mass as measured by dual energy x-ray absorptiometry
Time Frame
8 weeks
Title
Change in elbow flexor muscle thickness (cm)
Description
Muscle thickness as assessed by ultrasound
Time Frame
8 weeks
Title
Change in knee extensor muscle thickness (cm)
Description
muscle thickness as measured by ultrasound
Time Frame
8 weeks
Title
Change in bench press strength (kg)
Description
Bench press strength as assess on a plate-loaded machine by the 1-RM method
Time Frame
8 weeks
Title
Change in arm curl strength (kg)
Description
Arm curl strength as assessed with dumbbells by the 1-RM method
Time Frame
8 weeks
Title
Change in leg press strength (kg)
Description
Leg press strength as assessed on a leg-press machine by the 1-RM method
Time Frame
8 weeks
Title
Change in inflammation by interleukin-6 (mmol/l) levels
Description
Interleukin-6 levels measured from saliva samples
Time Frame
8 weeks
Title
Change in inflammation by C-reactive protein (mmol/l) levels
Description
C-reactive protein levels measured from saliva samples
Time Frame
8 weeks
Title
Change in bone resorption (N-telopeptides) (mmol/l)
Description
N-telopeptides measured from urine samples
Time Frame
8 weeks
Title
Change in voluntary muscle activation (Nm)
Description
Voluntary muscle activation as measured by the interpolated twitch technique
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least 6 months experience with resistance training
Exclusion Criteria:
Allergies to hemp or soy
Consumption of other nutritional supplements in previous month
Answered "yes" to questions on the Physical Activity Readiness Questionnaire
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Chilibeck
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 5B2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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The Benefits of Hemp Protein Supplementation During Resistance Training
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