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The Benefits of Hemp Protein Supplementation During Resistance Training

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ClinicalTrials.gov Identifier: NCT02529917
Recruitment Status : Completed
First Posted : August 20, 2015
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Phil Chilibeck, University of Saskatchewan

Tracking Information
First Submitted Date  ICMJE August 11, 2015
First Posted Date  ICMJE August 20, 2015
Last Update Posted Date May 5, 2017
Study Start Date  ICMJE August 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2015)
Change in lean tissue mass (kg) [ Time Frame: 8 weeks ]
Lean tissue mass measured with dual energy x-ray absrorptiometry
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2015)
  • Change in fat mass (kg) [ Time Frame: 8 weeks ]
    Fat mass as measured by dual energy x-ray absorptiometry
  • Change in bone mass (grams) [ Time Frame: 8 weeks ]
    Bone mass as measured by dual energy x-ray absorptiometry
  • Change in elbow flexor muscle thickness (cm) [ Time Frame: 8 weeks ]
    Muscle thickness as assessed by ultrasound
  • Change in knee extensor muscle thickness (cm) [ Time Frame: 8 weeks ]
    muscle thickness as measured by ultrasound
  • 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
  • Change in arm curl strength (kg) [ Time Frame: 8 weeks ]
    Arm curl strength as assessed with dumbbells by the 1-RM method
  • 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
  • Change in inflammation by interleukin-6 (mmol/l) levels [ Time Frame: 8 weeks ]
    Interleukin-6 levels measured from saliva samples
  • Change in inflammation by C-reactive protein (mmol/l) levels [ Time Frame: 8 weeks ]
    C-reactive protein levels measured from saliva samples
  • Change in bone resorption (N-telopeptides) (mmol/l) [ Time Frame: 8 weeks ]
    N-telopeptides measured from urine samples
  • Change in voluntary muscle activation (Nm) [ Time Frame: 8 weeks ]
    Voluntary muscle activation as measured by the interpolated twitch technique
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Benefits of Hemp Protein Supplementation During Resistance Training
Official Title  ICMJE The Benefits of Hemp Protein Supplementation During Resistance Training
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Sarcopenia
Intervention  ICMJE
  • Dietary Supplement: Hemp powder
    Hemp powder supplement
  • Dietary Supplement: Soy Powder
    Soy powder supplement
Study Arms  ICMJE
  • Experimental: Hemp powder
    Hemp powder supplement
    Intervention: Dietary Supplement: Hemp powder
  • Active Comparator: Soy powder
    Soy powder supplement
    Intervention: Dietary Supplement: Soy Powder
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2016)
34
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2015)
40
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02529917
Other Study ID Numbers  ICMJE 15-95
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Phil Chilibeck, University of Saskatchewan
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip Chilibeck University of Saskatchewan
PRS Account University of Saskatchewan
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP