NCT04819789

Digestibility of Fermotein™

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Wageningen University and Research · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study aims to assess the degree of digestibility of 3 different Fermotein™ products and compare this to a reference commercially available Mycoprotein (Quorn) and to assess the effects on blood glucose and insulin levels. The study has a randomized, cross-over, double blind, controlled design. Four different treatments, all representing a 20g protein load, will be evaluated with a washout period of minimum one week between the test days. On test days, research subjects will receive a product e.g. Fermotein™ dry, Fermotein™ wet, modified Fermotein™ wet and a reference Mycoprotein (Quorn), in the form of a porridge, in randomized order. Blood will be collected via a catheter before and up-to five hours after protein consumption. Wellbeing, health complaints or other adverse effects will be collected via short questionnaires during each test day. After each test day gastrointestinal complaints are collected via an online questionnaire.

Detailed description

Mycoprotein is a protein source derived from fungi produced for human consumption. It is high in protein, high in fiber, low in saturated fat and contains no cholesterol. Their functional properties and nutrient content make them ideal to use as an ingredient for meat alternatives. Fermotein™ is such a mycoprotein type novel food source. The digestion characteristics of Fermotein™ are not known, but essential to evaluate their future potential as a sustainable protein source. Also, information on the degree of digestibility would strengthen a novel food dossier that is being constructed for this product. The primary objective is to assess the degree of digestibility of 3 different Fermotein™ products and compare this to a reference commercially available Mycoprotein (Quorn). Secondary objectives are to assess the effects on blood glucose and insulin levels. The study has a randomized, cross-over, double blind, controlled design. Four different treatments, all representing a 20g protein load, will be evaluated with a washout period of minimum one week between the test days. On test days, research subjects will receive a product e.g. Fermotein™ dry, Fermotein™ wet, modified Fermotein™ wet and a reference Mycoprotein (Quorn), in the form of a porridge, in randomized order. Blood will be collected via a catheter before and up-to five hours after protein consumption. Wellbeing, health complaints or other adverse effects will be collected via short questionnaires during each test day. After each test day gastrointestinal complaints are collected via an online questionnaire.

Conditions

• Digestive System

Interventions

Type	Name	Description
OTHER	Fermotein™ dry powder porridge	At one out of four test days: Fermotein™ dry powder mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load.
OTHER	Fermotein™ wet porridge	At one out of four test days: Fermotein™ wet mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load.
OTHER	Fermotein™ modified wet porridge	At one out of four test days: Fermotein™ modified wet mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load.
OTHER	Mycoprotein porridge (matching control)	At one out of four test days: Mycoprotein (Quorn) mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load.

Timeline

• Start date: 2021-04-13
• Primary completion: 2021-05-20
• Completion: 2021-05-20
• First posted: 2021-03-29
• Last updated: 2021-05-25

Locations

1 site across 1 country: Netherlands