The primary objective is to assess the degree of digestibility of 3 different Fermotein products and compare this to a reference commercially available Mycoprotein.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
opname van eiwitten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the degree of digestibility determined e.g. the
appearance of free amino acids in blood samples collected before and after
consumption.
Secondary outcome
Secondary outcomes are plasma glucose and insulin levels.
Background summary
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 makes
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.
Study objective
The primary objective is to assess the degree of digestibility of 3 different
Fermotein products and compare this to a reference commercially available
Mycoprotein.
Study design
The study has a randomised, cross-over, double blind, controlled design. Four
different treatments will be evaluated with a washout period of one week
between the test days. On test days, study subjects will receive a product in
randomised order. Blood will be collected via a catheter before and up-to five
hours after protein consumption.
Intervention
Study subjects will receive a product e.g. Fermotein dry, Fermotein wet,
modified Fermotein wet and a reference Mycoprotein. All representing a 20g
protein load in, randomised order.
Study burden and risks
This study is not related to a specific group. There are minor risks for the
participants of this study. There are no direct benefits for the participants.
Fermotein has been analysed thoroughly on safety parameters and no harm is
expected. The total amount of blood collected is spread over 5 weeks and we
will exclude study participants with anaemia. Blood collection will therefore
not expected to cause any problems. Study subjects that will participate in the
study will invest approximately 26 hours during the trial.
Bornse Weilanden 9
Wageningen 6708 WG
NL
Bornse Weilanden 9
Wageningen 6708 WG
NL
Listed location countries
Age
Inclusion criteria
* Healthy men and women;
* Age between 18 and 70 years ;
* Having veins suitable for blood sampling via a catheter (judged by study
nurse/ medical doctor);
* Body mass index (BMI) between 18.5 and 30 kg/m2
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 gastro-intestinal surgery or having (serious) gastro-intestinal
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 will be judged by the medical supervisor;
* Anaemia (Hb values <7.5mmol/L for women and <8.5mmol/L for men);
* Reported slimming, medically prescribed or other extreme diets or the use of
protein supplements;
* 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 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | het traject loopt |
| CCMO | NL74595.081.20 |