NCT03034239

Brief Summary

Purpose: to study the effect of insect protein on performance and hypertrophy during 8 weeks of resistance training. Hypothesis: Insect protein supplementation enhances the effect of resistance training on muscle mass and muscle strength. Primary outcome: Muscle hypertrophy and muscle strength Design: Two groups of healthy young men (age: 18-30 years) with resistance training experience, but no structural resistance training performed for the last 12 months. Randomized controlled intervention study +/- insect protein (placebo group ingest isocaloric carbohydrate). Both groups perform 8 weeks of progressive resistance training (4/week) aiming to induce muscle hypertrophy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 20, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 9, 2017

Status Verified

January 1, 2017

Enrollment Period

1 month

First QC Date

January 23, 2017

Last Update Submit

May 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle hypertrophy

    muscle mass measured by DXA-scan

    8 weeks

Secondary Outcomes (1)

  • Muscle Strength

    8 weeks

Study Arms (2)

Insect protein group

EXPERIMENTAL

Exercise + insect protein 8 weeks of 4/week progressive resistance training (2 days upper body, 2 days lower body). Insect protein supplementation (4g/kg) after each training + before sleep at training days, and once in the morning at non training days.

Dietary Supplement: Protein supplementationOther: Resistance training

Placebo group

PLACEBO COMPARATOR

Exercise + isocaloric carbohydrate 8 weeks of 4/week progressive resistance training (2 days upper body, 2 days lower body). Carbohydrate supplementation (isocaloric to protein group) after each training + before sleep at training days, and once in the morning at non training days.

Other: Resistance training

Interventions

Protein supplementationDIETARY_SUPPLEMENT

\+ insect protein

Insect protein group

Resistance exercise

Insect protein groupPlacebo group

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young men (age: 18-30 years) with experience in resistance training
  • hours of physical exercise per week or more

You may not qualify if:

  • No structural resistance training for the last 12 months
  • No injuries
  • No smoking
  • No ingesting of protein or creating supplementations
  • No use of medicine which may influence the adaptation to strength training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University, Department for Public Health, Section for Sport Science

Aarhus, 8000, Denmark

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mette Hansen, PhD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2017

First Posted

January 27, 2017

Study Start

March 20, 2017

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 9, 2017

Record last verified: 2017-01

Locations