Insect Protein and Muscle Protein Signaling

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633694
• Other study ID #: Proteinlab P4 Insect
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: November 8, 2023

Study information

• Verified date: May 2024
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 8, 2023
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Public Health,	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	AP Moeller Foundation, Beckett Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 hours
Primary	Blod and urine metabolism by NMR	Both blod and urine are analysed by nuclear magnetic resonance (NMR) metabolomics to enlighten changes in the metabolites.	4 hours
Primary	Muscle metabolism by NMR	The muscle metabolites are quantified before intervention, after protein and after protein end exercise.	3 hours
Secondary	BMI	Control parameter between groups. Measured before the study day.	1 hour
Secondary	General physical activity	in the last 3 month. Self-reported through a questionnaire.	3 months
Secondary	Blood glucose	Blood glucose measured at 7 time points over the 4 hour period.	4 hours
Secondary	Blood Insulin	Blood insulin is measured at 7 time points over the 4 hour period.	4 hours
Secondary	Food intake, calories and distribution of macro nutrients.	Control parameter between groups. Self-reported diet report.	1 day