Protein SupplementationNCT03034239
The Effect of Insect Protein on Performance and Hypertrophy
A study testing Protein supplementation and Resistance training in people with Protein Supplementation, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Protein Supplementation
- What is being tested?
- Protein supplementation and Resistance training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Mar 2017to 1 May 2017
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young men (age: 18-30 years) with experience in resistance training
- 2 hours of physical exercise per week or more
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Department for Public Health, Section for Sport Science
Aarhus, 8000
About this study
Official title: The Effect of Insect Protein on Performance and Hypertrophy During Eight Weeks of Resistance Training
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.
- Conditions
- Protein Supplementation
- Being tested
- Protein supplementation, Resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein supplementationDietary supplement
+ insect protein
Resistance trainingOther
Resistance exercise
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Protein supplementation; Other: 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. Receives: Other: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle hypertrophy
muscle mass measured by DXA-scan
Measured: 8 weeks
Secondary outcomes (1)
Muscle Strength
muscle strength measured by maximal isometric muscle strength, 1RM at bench press and leg press and 80% 1RM to fatigue in bech and leg press
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 posted27 Jan 2017 (estimated)
- Study start20 Mar 2017
- Primary completion1 May 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein SupplementationStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mette Hansen, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034239
- Sponsor's protocol ID
- Insect2017
- Status last verified
- Jan 2017
- First submitted
- 23 Jan 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Insect Protein on Performance and Hypertrophy During Eight Weeks of Resistance Training
- ClinicalTrials.gov ID
- NCT03034239
- Acronym / sponsor ID
- Insect2017
- Conditions
- Protein Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 27 Jan 2017 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insect protein group | Experimental | Dietary Supplement: Protein supplementation, Other: Resistance trainingExercise + 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. |
| Placebo group | Placebo comparator | Other: Resistance trainingExercise + 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy young men (age: 18-30 years) with experience in resistance training
- 2 hours of physical exercise per week or more
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Protein supplementation+ insect protein | Dietary supplement | Insect protein group |
| Resistance trainingResistance exercise | Other | Insect protein group, Placebo group |
Primary outcome
Muscle hypertrophy
Time frame: 8 weeks
muscle mass measured by DXA-scan
1 secondary outcome
Muscle Strength
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 9 May 2017.
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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.
Mette Hansen, PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein supplementation and Resistance training in people with Protein Supplementation, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 5 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 9 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Muscle hypertrophy (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2017.