Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG, Netherlands
NCT Number: NCT04819789
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Wageningen, Gelderland, 6708 WG, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Other names: Quorn
Time frame: During the intervention period on 4 test days: at baseline and postprandial blood samples will be collected from the cannula at 10 time points (T=0, 30, 60, 75, 90, 120, 150, 180, 240, 300 minutes).
In order to assess change in the degree of digestibility, we determine 19 free amino acids in blood samples collected via a catheter before and at several time points up-to five hours after protein source consumption. Blood amino acids will be determined by the laboratory of Wageningen FBR, according a valid method: AccQ-Tag ultra-derivation kit & HPLC.
Time frame: During the intervention period on 4 test days: at baseline and postprandial blood samples will be collected from the cannula at 9 time points (T=0, 30, 60, 90, 120, 150, 180, 240, 300 minutes).
Plasma glucose levels will be determined in blood samples collected via a catheter before and at several time points up-to five hours after protein source consumption (hospital laboratory Ziekenhuis Gelderse vallei, Ede, the Netherlands).
Time frame: During the intervention period on 4 test days: at baseline and postprandial blood samples will be collected from the cannula at 9 time points (T=0, 30, 60, 90, 120, 150, 180, 240, 300 minutes).
Plasma insulin levels will be determined in blood samples collected via a catheter before and at several time points up-to five hours after protein source consumption (hospital laboratory Ziekenhuis Gelderse vallei, Ede, the Netherlands).
Wageningen University and Research
Other
Acronym: MyDi
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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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