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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02529917
Other study ID # 15-95
Secondary ID
Status Completed
Phase N/A
First received August 11, 2015
Last updated May 2, 2017
Start date August 2015
Est. completion date December 2015

Study information

Verified date May 2017
Source University of Saskatchewan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Hemp powder
Hemp powder supplement
Soy Powder
Soy powder supplement

Locations

Country Name City State
Canada University of Saskatchewan Saskatoon Saskatchewan

Sponsors (1)

Lead Sponsor Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in lean tissue mass (kg) Lean tissue mass measured with dual energy x-ray absrorptiometry 8 weeks
Secondary Change in fat mass (kg) Fat mass as measured by dual energy x-ray absorptiometry 8 weeks
Secondary Change in bone mass (grams) Bone mass as measured by dual energy x-ray absorptiometry 8 weeks
Secondary Change in elbow flexor muscle thickness (cm) Muscle thickness as assessed by ultrasound 8 weeks
Secondary Change in knee extensor muscle thickness (cm) muscle thickness as measured by ultrasound 8 weeks
Secondary Change in bench press strength (kg) Bench press strength as assess on a plate-loaded machine by the 1-RM method 8 weeks
Secondary Change in arm curl strength (kg) Arm curl strength as assessed with dumbbells by the 1-RM method 8 weeks
Secondary Change in leg press strength (kg) Leg press strength as assessed on a leg-press machine by the 1-RM method 8 weeks
Secondary Change in inflammation by interleukin-6 (mmol/l) levels Interleukin-6 levels measured from saliva samples 8 weeks
Secondary Change in inflammation by C-reactive protein (mmol/l) levels C-reactive protein levels measured from saliva samples 8 weeks
Secondary Change in bone resorption (N-telopeptides) (mmol/l) N-telopeptides measured from urine samples 8 weeks
Secondary Change in voluntary muscle activation (Nm) Voluntary muscle activation as measured by the interpolated twitch technique 8 weeks
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