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Insect Protein and Muscle Protein Signaling

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ClinicalTrials.gov Identifier: NCT04633694
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Collaborators:
AP Moeller Foundation
Beckett Foundation
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Sarcopenia Dietary Supplement: insect, pea or whey protein Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A parallel 3 armed study, each arm with a different protein type
Masking: Double (Participant, Care 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.
Primary Purpose: Prevention
Official Title: Insect Protein - a New and Sustainable Protein Source to Maintain and Build Muscle
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Insect protein
The participants are are given insect protein
Dietary Supplement: insect, pea or 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.

Experimental: Pea protein
The participants are are given pea protein
Dietary Supplement: insect, pea or 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.

Experimental: Whey protein
The participants are are given whey protein
Dietary Supplement: insect, pea or 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Muscle metabolism by NMR [ Time Frame: 3 hours ]
    The muscle metabolites are quantified before intervention, after protein and after protein end exercise.


Secondary Outcome Measures :
  1. BMI [ Time Frame: 1 hour ]
    Control parameter between groups. Measured before the study day.

  2. General physical activity [ Time Frame: 3 months ]
    in the last 3 month. Self-reported through a questionnaire.

  3. Blood glucose [ Time Frame: 4 hours ]
    Blood glucose measured at 7 time points over the 4 hour period.

  4. Blood Insulin [ Time Frame: 4 hours ]
    Blood insulin is measured at 7 time points over the 4 hour period.

  5. Food intake, calories and distribution of macro nutrients. [ Time Frame: 1 day ]
    Control parameter between groups. Self-reported diet report.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Biological males
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04633694


Contacts
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Contact: Mette Hansen, Phd +4551666551 mhan@ph.au.dk
Contact: Sofie K Ovesen, Cand.scient +45 20 71 58 45 sofiekaasovesen@food.au.dk

Locations
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Denmark
Department of Public Health, Recruiting
Aarhus, Denmark, 8000
Contact: Mette Hansen, Phd    +4551666551    mhan@ph.au.dk   
Sponsors and Collaborators
University of Aarhus
AP Moeller Foundation
Beckett Foundation
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04633694    
Other Study ID Numbers: Proteinlab P4 Insect
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All analysis will be performed within the research team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
mTORC metabolomics,
Western blotting
Real time quantitative polymerase chain reaction
Nuclear magnetic resonance
Liquid chromatography-mass spectrometry
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical