Insect Protein and Muscle Protein Signaling
Primary Purpose
Sarcopenia
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
insect, pea or whey protein
Sponsored by
About this trial
This is an interventional prevention trial for Sarcopenia focused on measuring mTORC metabolomics,, Western blotting, Real time quantitative polymerase chain reaction, Nuclear magnetic resonance, Liquid chromatography-mass spectrometry
Eligibility Criteria
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.
Sites / Locations
- Department of Public Health,
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Insect protein
Pea protein
Whey protein
Arm Description
The participants are are given insect protein
The participants are are given pea protein
The participants are are given whey protein
Outcomes
Primary Outcome Measures
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.
Blod and urine metabolism by NMR
Both blod and urine are analysed by nuclear magnetic resonance (NMR) metabolomics to enlighten changes in the metabolites.
Muscle metabolism by NMR
The muscle metabolites are quantified before intervention, after protein and after protein end exercise.
Secondary Outcome Measures
BMI
Control parameter between groups. Measured before the study day.
General physical activity
in the last 3 month. Self-reported through a questionnaire.
Blood glucose
Blood glucose measured at 7 time points over the 4 hour period.
Blood Insulin
Blood insulin is measured at 7 time points over the 4 hour period.
Food intake, calories and distribution of macro nutrients.
Control parameter between groups. Self-reported diet report.
Full Information
NCT ID
NCT04633694
First Posted
August 10, 2020
Last Updated
May 17, 2022
Sponsor
University of Aarhus
Collaborators
AP Moeller Foundation, Beckett Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04633694
Brief Title
Insect Protein and Muscle Protein Signaling
Official Title
Insect Protein - a New and Sustainable Protein Source to Maintain and Build Muscle
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
AP Moeller Foundation, Beckett Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
mTORC metabolomics,, Western blotting, Real time quantitative polymerase chain reaction, Nuclear magnetic resonance, Liquid chromatography-mass spectrometry
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A parallel 3 armed study, each arm with a different protein type
Masking
ParticipantCare Provider
Masking Description
The project leader are responsible for the masking while all other persons involved in the project do not know the protein source given.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Insect protein
Arm Type
Experimental
Arm Description
The participants are are given insect protein
Arm Title
Pea protein
Arm Type
Experimental
Arm Description
The participants are are given pea protein
Arm Title
Whey protein
Arm Type
Experimental
Arm Description
The participants are are given whey protein
Intervention Type
Dietary Supplement
Intervention Name(s)
insect, pea or whey protein
Intervention Description
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.
Primary Outcome Measure Information:
Title
Expression and phosphorylation of signaling proteins and their mRNA by Western Blotting and PCR
Description
Change in expression and phosphorylation of signaling proteins and the mRNA related the muscle protein synthesis.
Time Frame
4 hours
Title
Blod and urine metabolism by NMR
Description
Both blod and urine are analysed by nuclear magnetic resonance (NMR) metabolomics to enlighten changes in the metabolites.
Time Frame
4 hours
Title
Muscle metabolism by NMR
Description
The muscle metabolites are quantified before intervention, after protein and after protein end exercise.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
BMI
Description
Control parameter between groups. Measured before the study day.
Time Frame
1 hour
Title
General physical activity
Description
in the last 3 month. Self-reported through a questionnaire.
Time Frame
3 months
Title
Blood glucose
Description
Blood glucose measured at 7 time points over the 4 hour period.
Time Frame
4 hours
Title
Blood Insulin
Description
Blood insulin is measured at 7 time points over the 4 hour period.
Time Frame
4 hours
Title
Food intake, calories and distribution of macro nutrients.
Description
Control parameter between groups. Self-reported diet report.
Time Frame
1 day
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Biological males
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Public Health,
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All analysis will be performed within the research team.
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Insect Protein and Muscle Protein Signaling
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