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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hemp powder
Hemp powder supplement
Dietary supplement: Hemp powder
Hemp powder supplement
Active Comparator: Soy powder
Soy powder supplement
Dietary supplement: Soy Powder
Soy powder supplement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Saskatchewan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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