The primary objective is to investigate gastro-intestinal complaints during 18 day Fermotein consumption. Secondary objectives are to assess blood based parameters related to general health. Outcomes will be part of a novel food dossier.
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal disorders
Synonym
Health condition
overige gezondheids parameters
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primairy study parameter is frequency and severity of gastro-intestinal
complaints.
Secondary outcome
Secondary outcomes are health parameters derived from blood samples taken
before and after the intervention.Additional samples (including stool samples)
will be collected to enable future measurements when requested by the
assessment committee of the novel food dossier
Background summary
Mycoprotein is a protein source derived from fungi, especially as 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.
Study objective
The primary objective is to investigate gastro-intestinal complaints during 18
day Fermotein consumption. Secondary objectives are to assess blood based
parameters related to general health. Outcomes will be part of a novel food
dossier.
Study design
The study has a randomised parallel design. Two different treatments will be
evaluated e.g. a 18-day intervention with Fermotein based meals (bread and an
occasional burger) and a 18-day intervention with matching control meals. At
start and at the end of the intervention we will collect a blood, faecal and
urine sample. Questionnaires about gut complaints, stool consistency and
frequency, wellbeing, health complaints or other adverse effects will be
collected daily during intervention and up to two days after intervention.
Intervention
Subjects will daily consume a lunch meal containing approximately 11g of
Fermotein or control for 18 days.
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 during the study is low and
therefore not expected to cause any problems. Study subjects that will
participate in the study will invest approximately 30 hours during the trial
and need to visit the research facility daily during working days for three
weeks
Goeseelsstraat 10
Breda 4817 MV
NL
Goeseelsstraat 10
Breda 4817 MV
NL
Listed location countries
Age
Inclusion criteria
Apparently healthy men and women
Age between 18 and 70 years
Body mass index (BMI) between 18.5 and 29.9 kg/m2
Exclusion criteria
* Any metabolic, gastrointestinal, inflammatory or chronic disease (such as
diabetes, anaemia, hepatitis, cardiovascular disease)
* History of gastro-intestinal surgery or having (serious) gastro-intestinal
complaints
* History of liver dysfunction (cirrhosis, hepatitis)
* Kidney dysfunction (self-reported)
* Use of medication that may influence the study results, such as gastric acid
inhibitors or laxatives
* Reported slimming or medically prescribed diet
* 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 illicit drugs
* Having food allergies
* Participation in another clinical trial at the same time
* Being an employee of the department Consumer Science & Health group 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 | NL72349.081.19 |