SarcopeniaNCT02529917
The Benefits of Hemp Protein Supplementation During Resistance Training
A study testing Hemp powder and Soy Powder in people with Sarcopenia, run by University of Saskatchewan at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Hemp powder and Soy Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least 6 months experience with resistance training
Who cannot join
- Allergies to hemp or soy
- Consumption of other nutritional supplements in previous month
- Answered "yes" to questions on the Physical Activity Readiness Questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sarcopenia
- Being tested
- Hemp powder, Soy Powder
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemp powderDietary supplement
Hemp powder supplement
Soy PowderDietary supplement
Soy powder supplement
| Study group | Role | What they receive |
|---|---|---|
| Hemp powder | Experimental | Hemp powder supplement Receives: Dietary Supplement: Hemp powder |
| Soy powder | Active comparator | Soy powder supplement Receives: Dietary Supplement: Soy Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lean tissue mass (kg)
Lean tissue mass measured with dual energy x-ray absrorptiometry
Measured: 8 weeks
Secondary outcomes (11)
Change in fat mass (kg)
Fat mass as measured by dual energy x-ray absorptiometry
Measured: 8 weeks
Change in bone mass (grams)
Bone mass as measured by dual energy x-ray absorptiometry
Measured: 8 weeks
Change in elbow flexor muscle thickness (cm)
Muscle thickness as assessed by ultrasound
Measured: 8 weeks
Change in knee extensor muscle thickness (cm)
muscle thickness as measured by ultrasound
Measured: 8 weeks
Change in bench press strength (kg)
Bench press strength as assess on a plate-loaded machine by the 1-RM method
Measured: 8 weeks
Change in arm curl strength (kg)
Arm curl strength as assessed with dumbbells by the 1-RM method
Measured: 8 weeks
Change in leg press strength (kg)
Leg press strength as assessed on a leg-press machine by the 1-RM method
Measured: 8 weeks
Change in inflammation by interleukin-6 (mmol/l) levels
Interleukin-6 levels measured from saliva samples
Measured: 8 weeks
Change in inflammation by C-reactive protein (mmol/l) levels
C-reactive protein levels measured from saliva samples
Measured: 8 weeks
Change in bone resorption (N-telopeptides) (mmol/l)
N-telopeptides measured from urine samples
Measured: 8 weeks
Change in voluntary muscle activation (Nm)
Voluntary muscle activation as measured by the interpolated twitch technique
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phil Chilibeck, University of Saskatchewan
- Investigators
- Philip Chilibeck, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529917
- Sponsor's protocol ID
- 15-95
- Status last verified
- May 2017
- First submitted
- 11 Aug 2015
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kaviani M, Shaw KA, Candow DG, Farthing JP, Chilibeck PD. Effects of hemp supplementation during resistance training in trained young adults. Eur J Appl Physiol. 2024 Apr;124(4):1097-1107. doi: 10.1007/s00421-023-05337-7. Epub 2023 Oct 17.
PubMed 37847288
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of Hemp Protein Supplementation During Resistance Training
- ClinicalTrials.gov ID
- NCT02529917
- Acronym / sponsor ID
- 15-95
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemp powder | Experimental | Dietary Supplement: Hemp powderHemp powder supplement |
| Soy powder | Active comparator | Dietary Supplement: Soy PowderSoy powder supplement |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- At least 6 months experience with resistance training
Key exclusion criteria (3 listed)
- Allergies to hemp or soy
- Consumption of other nutritional supplements in previous month
- Answered "yes" to questions on the Physical Activity Readiness Questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemp powderHemp powder supplement | Dietary supplement | Hemp powder |
| Soy PowderSoy powder supplement | Dietary supplement | Soy powder |
Primary outcome
Change in lean tissue mass (kg)
Time frame: 8 weeks
Lean tissue mass measured with dual energy x-ray absrorptiometry
11 secondary outcomes
Change in fat mass (kg)
Time frame: 8 weeks
Change in bone mass (grams)
Time frame: 8 weeks
Change in elbow flexor muscle thickness (cm)
Time frame: 8 weeks
Change in knee extensor muscle thickness (cm)
Time frame: 8 weeks
Change in bench press strength (kg)
Time frame: 8 weeks
Change in arm curl strength (kg)
Time frame: 8 weeks
Change in leg press strength (kg)
Time frame: 8 weeks
Change in inflammation by interleukin-6 (mmol/l) levels
Time frame: 8 weeks
Change in inflammation by C-reactive protein (mmol/l) levels
Time frame: 8 weeks
Change in bone resorption (N-telopeptides) (mmol/l)
Time frame: 8 weeks
Change in voluntary muscle activation (Nm)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Derived from this study: PubMed 37847288Kaviani M, Shaw KA, Candow DG, Farthing JP, Chilibeck PD. Effects of hemp supplementation during resistance training in trained young adults. Eur J Appl Physiol. 2024 Apr;124(4):1097-1107. doi: 10.1007/s00421-023-05337-7. Epub 2023 Oct 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Chilibeck principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemp powder and Soy Powder in people with Sarcopenia, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lean tissue mass (kg) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02529917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.