SarcopeniaNCT04633694
Insect Protein and Muscle Protein Signaling
A study testing insect, pea or whey protein in people with Sarcopenia, run by University of Aarhus at 1 site in Denmark.
Trial summary
Randomized parallel study investing the effect of intake of different protein sources (whey, insect and pea) on the muscle protein synthesis. Activation of the signaling pathway leading to muscle protein synthesis is investigated by western blotting and Real time quantitative polymerase chain reaction (qPCR or PCR). 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
- Sarcopenia
- What is being tested?
- insect, pea or whey protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2020to 8 Nov 2023
- 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
- male
- 18-30 year
- able to read and understand danish
Who cannot join
- smoking
- resistance training more than 1 time pr month
- endurance training more than 2 hours pr week
- Allergy toward shellfish, house dust mites or the protein sources.
- knee problems effecting the exercise
- weight change more than 5 kg the last half year
- medicine which can effect the protein turnover
- Disease in joint, or muscle as well as metabolic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insect Protein - a New and Sustainable Protein Source to Maintain and Build Muscle
Randomized parallel study investing the effect of intake of different protein sources (whey, insect and pea) on the muscle protein synthesis. Activation of the signaling pathway leading to muscle protein synthesis is investigated by western blotting and Real time quantitative polymerase chain reaction (qPCR or PCR). Urine, blood and muscle is moreover investigated by metabolomics analysis.
Read the detailed description
Background:
Sarcopenia is a syndrome highly prevalent in the older population, characterized by muscle loss and a decrease in muscle strength. This leads to loss of physical function, decreased life quality and well-being and an increased risk of early death. Research has shown that both ingestion of protein and physical activity is able to diminish the loss of muscle mass during aging and thereby reduce the prevalence of sarcopenia and diminish the consequence of the disease. This study will investigate if more sustainable protein sources of good quality can increase the muscle protein synthesis and thereby prevent sarcopenia.
Aim:
The aim of this project is to investigate the effects of insect protein on the stimulation of muscle protein synthesis. The effects of protein will both be studied alone and in combination with exercise in perspective of preventing loss of both muscle mass and muscle strength. The potential of insect protein will be elucidated by comparison with other alternative plant-based protein sources in this case pea protein. In addition, whey protein will be included as a positive control as it may be regarded as the most established dietary protein source combatting muscle loss.
Method:
Young(18-30 years old) healthy men (n=60) are randomized in 3 groups to ingest either insect protein, pea protein or whey protein. Urine are collected 24 hours prior to the experiment while a blood sample and a muscle biopsy is collected at the beginning of the study. The subjects are instructed to perform one-leg exercise (knee extension, 5 sets of 10 repetitions, 10 repetitions-maximum) after which the subjects ingest the assigned protein bolus. Urine and blood samples are collected in the following hours and one muscle biopsy is collected from both the exercised and the non-exercised leg at 3 hours after protein ingestion. The expression of messenger RNA (mRNA) and protein related to the mTORC pathway in the muscle is investigated by qPCR and western blotting. In addition, metabolites in urine, blood plasma and muscle tissue are investigated by metabolomics analysis.
- Conditions
- Sarcopenia
- Being tested
- insect, pea or whey protein
- Keywords
- mTORC metabolomics,, Western blotting, Real time quantitative polymerase chain reaction, Nuclear magnetic resonance, Liquid chromatography-mass spectrometry
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insect, pea or whey proteinDietary supplement
The protein powder is dissolved in 400 mL water and given relative to lean body mass, 0.25 g protein pr kg lean body mass.
| Study group | Role | What they receive |
|---|---|---|
| Insect protein | Experimental | The participants are are given insect protein Receives: Dietary Supplement: insect, pea or whey protein |
| Pea protein | Experimental | The participants are are given pea protein Receives: Dietary Supplement: insect, pea or whey protein |
| Whey protein | Experimental | The participants are are given whey protein Receives: Dietary Supplement: insect, pea or whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression and phosphorylation of signaling proteins and their mRNA by Western Blotting and PCR
Change in expression and phosphorylation of signaling proteins and the mRNA related the muscle protein synthesis.
Measured: 4 hours
Blod and urine metabolism by NMR
Both blod and urine are analysed by nuclear magnetic resonance (NMR) metabolomics to enlighten changes in the metabolites.
Measured: 4 hours
Muscle metabolism by NMR
The muscle metabolites are quantified before intervention, after protein and after protein end exercise.
Measured: 3 hours
Secondary outcomes (5)
BMI
Control parameter between groups. Measured before the study day.
Measured: 1 hour
General physical activity
in the last 3 month. Self-reported through a questionnaire.
Measured: 3 months
Blood glucose
Blood glucose measured at 7 time points over the 4 hour period.
Measured: 4 hours
Blood Insulin
Blood insulin is measured at 7 time points over the 4 hour period.
Measured: 4 hours
Food intake, calories and distribution of macro nutrients.
Control parameter between groups. Self-reported diet report.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Jun 2020
- Primary completion30 Nov 2020
- Study completion8 Nov 2023
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel 3 armed study, each arm with a different protein type
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- AP Moeller Foundation, Beckett Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633694
- Sponsor's protocol ID
- Proteinlab P4 Insect
- Status last verified
- May 2024
- First submitted
- 10 Aug 2020
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All analysis will be performed within the research team.
Publications
Lanng SK, Oxfeldt M, Pedersen SS, Johansen FT, Risikesan J, Lejel T, Bertram HC, Hansen M. Influence of protein source (cricket, pea, whey) on amino acid bioavailability and activation of the mTORC1 signaling pathway after resistance exercise in healthy young males. Eur J Nutr. 2023 Apr;62(3):1295-1308. doi: 10.1007/s00394-022-03071-y. Epub 2022 Dec 19.
PubMed 36536114
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insect Protein - a New and Sustainable Protein Source to Maintain and Build Muscle
- ClinicalTrials.gov ID
- NCT04633694
- Acronym / sponsor ID
- Proteinlab P4 Insect
- Conditions
- Sarcopenia
- Keywords
- mTORC metabolomics,, Western blotting, Real time quantitative polymerase chain reaction, Nuclear magnetic resonance, Liquid chromatography-mass spectrometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- AP Moeller Foundation, Beckett Foundation
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 18 Nov 2020 (actual)
- 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.
Randomized parallel study investing the effect of intake of different protein sources (whey, insect and pea) on the muscle protein synthesis. Activation of the signaling pathway leading to muscle protein synthesis is investigated by western blotting and Real time quantitative polymerase chain reaction (qPCR or PCR). Urine, blood and muscle is moreover investigated by metabolomics analysis.
Detailed description
Background:
Sarcopenia is a syndrome highly prevalent in the older population, characterized by muscle loss and a decrease in muscle strength. This leads to loss of physical function, decreased life quality and well-being and an increased risk of early death. Research has shown that both ingestion of protein and physical activity is able to diminish the loss of muscle mass during aging and thereby reduce the prevalence of sarcopenia and diminish the consequence of the disease. This study will investigate if more sustainable protein sources of good quality can increase the muscle protein synthesis and thereby prevent sarcopenia.
Aim:
The aim of this project is to investigate the effects of insect protein on the stimulation of muscle protein synthesis. The effects of protein will both be studied alone and in combination with exercise in perspective of preventing loss of both muscle mass and muscle strength. The potential of insect protein will be elucidated by comparison with other alternative plant-based protein sources in this case pea protein. In addition, whey protein will be included as a positive control as it may be regarded as the most established dietary protein source combatting muscle loss.
Method:
Young(18-30 years old) healthy men (n=60) are randomized in 3 groups to ingest either insect protein, pea protein or whey protein. Urine are collected 24 hours prior to the experiment while a blood sample and a muscle biopsy is collected at the beginning of the study. The subjects are instructed to perform one-leg exercise (knee extension, 5 sets of 10 repetitions, 10 repetitions-maximum) after which the subjects ingest the assigned protein bolus. Urine and blood samples are collected in the following hours and one muscle biopsy is collected from both the exercised and the non-exercised leg at 3 hours after protein ingestion. The expression of messenger RNA (mRNA) and protein related to the mTORC pathway in the muscle is investigated by qPCR and western blotting. In addition, metabolites in urine, blood plasma and muscle tissue are investigated by metabolomics analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- A parallel 3 armed study, each arm with a different protein type
| Arm | Type | Receives |
|---|---|---|
| Insect protein | Experimental | Dietary Supplement: insect, pea or whey proteinThe participants are are given insect protein |
| Pea protein | Experimental | Dietary Supplement: insect, pea or whey proteinThe participants are are given pea protein |
| Whey protein | Experimental | Dietary Supplement: insect, pea or whey proteinThe participants are are given whey protein |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male
- 18-30 year
- able to read and understand danish
Key exclusion criteria (8 listed)
- smoking
- resistance training more than 1 time pr month
- endurance training more than 2 hours pr week
- Allergy toward shellfish, house dust mites or the protein sources.
- knee problems effecting the exercise
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 |
|---|---|---|
| insect, pea or whey proteinThe protein powder is dissolved in 400 mL water and given relative to lean body mass, 0.25 g protein pr kg lean body mass. | Dietary supplement | Insect protein, Pea protein, Whey protein |
Primary outcome
Expression and phosphorylation of signaling proteins and their mRNA by Western Blotting and PCR
Time frame: 4 hours
Change in expression and phosphorylation of signaling proteins and the mRNA related the muscle protein synthesis.
Blod and urine metabolism by NMR
Time frame: 4 hours
Both blod and urine are analysed by nuclear magnetic resonance (NMR) metabolomics to enlighten changes in the metabolites.
Muscle metabolism by NMR
Time frame: 3 hours
The muscle metabolites are quantified before intervention, after protein and after protein end exercise.
5 secondary outcomes
BMI
Time frame: 1 hour
General physical activity
Time frame: 3 months
Blood glucose
Time frame: 4 hours
Blood Insulin
Time frame: 4 hours
Food intake, calories and distribution of macro nutrients.
Time frame: 1 day
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 31 May 2024.
- Derived from this study: PubMed 36536114Lanng SK, Oxfeldt M, Pedersen SS, Johansen FT, Risikesan J, Lejel T, Bertram HC, Hansen M. Influence of protein source (cricket, pea, whey) on amino acid bioavailability and activation of the mTORC1 signaling pathway after resistance exercise in healthy young males. Eur J Nutr. 2023 Apr;62(3):1295-1308. doi: 10.1007/s00394-022-03071-y. Epub 2022 Dec 19.
- Individual participant dataSharing planned: No. All analysis will be performed within the research team.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insect, pea or whey protein in people with Sarcopenia, 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 3 inclusion and 8 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 31 May 2024. 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. 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?
Expression and phosphorylation of signaling proteins and their mRNA by Western Blotting and PCR (time frame: 4 hours). The study lists 3 primary outcomes in all. 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 NCT04633694, 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 31 May 2024.