NCT02529917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

August 11, 2015

Last Update Submit

May 2, 2017

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

  • Change in lean tissue mass (kg)

    Lean tissue mass measured with dual energy x-ray absrorptiometry

    8 weeks

Secondary Outcomes (11)

  • Change in fat mass (kg)

    8 weeks

  • Change in bone mass (grams)

    8 weeks

  • Change in elbow flexor muscle thickness (cm)

    8 weeks

  • Change in knee extensor muscle thickness (cm)

    8 weeks

  • Change in bench press strength (kg)

    8 weeks

  • +6 more secondary outcomes

Study Arms (2)

Hemp powder

EXPERIMENTAL

Hemp powder supplement

Dietary Supplement: Hemp powder

Soy powder

ACTIVE COMPARATOR

Soy powder supplement

Dietary Supplement: Soy Powder

Interventions

Hemp powderDIETARY_SUPPLEMENT

Hemp powder supplement

Hemp powder
Soy PowderDIETARY_SUPPLEMENT

Soy powder supplement

Soy powder

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • At least 6 months experience with resistance training

You may not qualify if:

  • Allergies to hemp or soy
  • Consumption of other nutritional supplements in previous month
  • Answered "yes" to questions on the Physical Activity Readiness Questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 37847288DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Philip Chilibeck

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

August 11, 2015

First Posted

August 20, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 5, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)