Clinical trial NCT04633694: Insect Protein and Muscle Protein Signaling
Official title: Insect Protein - a New and Sustainable Protein Source to Maintain and Build Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: mTORC metabolomics,
Western blotting
Real time quantitative polymerase chain reaction
Nuclear magnetic resonance
Liquid chromatography-mass spectrometry
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: AP Moeller Foundation
name: Beckett Foundation
First posted: 2020-11-18
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel 3 armed study, each arm with a different protein type
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Expression and phosphorylation of signaling proteins and their mRNA by Western Blotting and PCR
timeFrame: 4 hours
measure: Blod and urine metabolism by NMR
timeFrame: 4 hours
measure: Muscle metabolism by NMR
timeFrame: 3 hours
Secondary outcomes:
measure: BMI
timeFrame: 1 hour
measure: General physical activity
timeFrame: 3 months
measure: Blood glucose
timeFrame: 4 hours
measure: Blood Insulin
timeFrame: 4 hours
measure: Food intake, calories and distribution of macro nutrients.
timeFrame: 1 day
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Public Health,
Study officials:
References: