- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02529917
The Benefits of Hemp Protein Supplementation During Resistance Training
May 2, 2017 updated by: Phil Chilibeck, University of Saskatchewan
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N 5B2
- University of Saskatchewan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hemp powder
Hemp powder supplement
|
Hemp powder supplement
|
|
Active Comparator: Soy powder
Soy powder supplement
|
Soy powder supplement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in lean tissue mass (kg)
Time Frame: 8 weeks
|
Lean tissue mass measured with dual energy x-ray absrorptiometry
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in fat mass (kg)
Time Frame: 8 weeks
|
Fat mass as measured by dual energy x-ray absorptiometry
|
8 weeks
|
|
Change in bone mass (grams)
Time Frame: 8 weeks
|
Bone mass as measured by dual energy x-ray absorptiometry
|
8 weeks
|
|
Change in elbow flexor muscle thickness (cm)
Time Frame: 8 weeks
|
Muscle thickness as assessed by ultrasound
|
8 weeks
|
|
Change in knee extensor muscle thickness (cm)
Time Frame: 8 weeks
|
muscle thickness as measured by ultrasound
|
8 weeks
|
|
Change in bench press strength (kg)
Time Frame: 8 weeks
|
Bench press strength as assess on a plate-loaded machine by the 1-RM method
|
8 weeks
|
|
Change in arm curl strength (kg)
Time Frame: 8 weeks
|
Arm curl strength as assessed with dumbbells by the 1-RM method
|
8 weeks
|
|
Change in leg press strength (kg)
Time Frame: 8 weeks
|
Leg press strength as assessed on a leg-press machine by the 1-RM method
|
8 weeks
|
|
Change in inflammation by interleukin-6 (mmol/l) levels
Time Frame: 8 weeks
|
Interleukin-6 levels measured from saliva samples
|
8 weeks
|
|
Change in inflammation by C-reactive protein (mmol/l) levels
Time Frame: 8 weeks
|
C-reactive protein levels measured from saliva samples
|
8 weeks
|
|
Change in bone resorption (N-telopeptides) (mmol/l)
Time Frame: 8 weeks
|
N-telopeptides measured from urine samples
|
8 weeks
|
|
Change in voluntary muscle activation (Nm)
Time Frame: 8 weeks
|
Voluntary muscle activation as measured by the interpolated twitch technique
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Philip Chilibeck, University of Saskatchewan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
August 11, 2015
First Submitted That Met QC Criteria
August 19, 2015
First Posted (Estimate)
August 20, 2015
Study Record Updates
Last Update Posted (Actual)
May 5, 2017
Last Update Submitted That Met QC Criteria
May 2, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-95
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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