- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04819789
Digestibility of Fermotein™ (MyDi)
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gelderland
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Wageningen, Gelderland, Netherlands, 6708 WG
- Stichting Wageningen Research
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Apparently healthy men and women;
- Age between 18 and 70 years;
- Body mass index (BMI) between 18.5 and 30 kg/m2 ;
- Having veins suitable for blood sampling via a catheter (judged by study nurse/ medical doctor).
Exclusion Criteria:
- Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease),or having a condition or disease that may lead to an impaired immune system
- History of gastrointestinal surgery or having (serious) gastrointestinal complaints;
- History of liver dysfunction (cirrhosis, hepatitis) or liver surgery;
- Kidney dysfunction (self-reported);
- Any use of medication that may suppress the immune system, this will be judged by the medical supervisor;
- Use of medication that may influence the study results, such as gastric acid inhibitors, laxatives, stomach protectors and drugs that can affect intestinal motility, this will be judged by the medical supervisor;
- Anaemia (Hb values <7.5 mmol/L for women and <8.5 mmol/L for men);
- Reported slimming, medically prescribed or other extreme diets;
- Not willing to give up blood donation during the study;
- Current smokers;
- Alcohol intake ≥4 glasses of alcoholic beverages per day;
- Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported);
- Abuse of hard drugs;
- Having food allergies;
- Not having a general practitioner;
- Participation in another clinical trial at the same time;
- Being an employee of the department Food, Health & Consumer Research of Wageningen Food & Biobased Research.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fermotein™ dry
Fermotein™ powder presented in the form of a 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.
|
Experimental: Fermotein™ wet
Fermotein™ wet presented in the form of a 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.
|
Experimental: Fermotein™ modified wet
Fermotein™ modified wet presented in the form of a 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.
|
Active Comparator: Mycoprotein
This mycoprotein product presented in the form of a porridge.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in degree of digestibility
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.
|
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).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in plasma glucose levels
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).
|
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).
|
Change in plasma insulin levels
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).
|
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).
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NL74595.081.20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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