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Completed

NCT Number: NCT04633694

Insect Protein and Muscle Protein Signaling

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.

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Key information

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Public Health,

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insect, pea or whey protein

Dietary 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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • AP Moeller Foundation
  • Beckett Foundation

Registry information

Official study title

Insect Protein - a New and Sustainable Protein Source to Maintain and Build Muscle

Important dates

Study start
2020
Primary completion
2020
Study completion
2023
First posted
Nov 18, 2020
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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