- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04633694
Insect Protein and Muscle Protein Signaling
Insect Protein - a New and Sustainable Protein Source to Maintain and Build Muscle
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Aarhus, Denmark, 8000
- Department of Public Health,
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- male
- 18-30 year
- able to read and understand danish
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Insect protein
The participants are are given insect protein
|
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.
|
|
Experimental: Pea protein
The participants are are given pea protein
|
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.
|
|
Experimental: Whey protein
The participants are are given whey protein
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 hours
|
|
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.
|
4 hours
|
|
Muscle metabolism by NMR
Time Frame: 3 hours
|
The muscle metabolites are quantified before intervention, after protein and after protein end exercise.
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BMI
Time Frame: 1 hour
|
Control parameter between groups.
Measured before the study day.
|
1 hour
|
|
General physical activity
Time Frame: 3 months
|
in the last 3 month.
Self-reported through a questionnaire.
|
3 months
|
|
Blood glucose
Time Frame: 4 hours
|
Blood glucose measured at 7 time points over the 4 hour period.
|
4 hours
|
|
Blood Insulin
Time Frame: 4 hours
|
Blood insulin is measured at 7 time points over the 4 hour period.
|
4 hours
|
|
Food intake, calories and distribution of macro nutrients.
Time Frame: 1 day
|
Control parameter between groups.
Self-reported diet report.
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Proteinlab P4 Insect
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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