Clinical trial NCT04590768: Tolerance of Regular Meal Intake With Mycoprotein (TOMMY)
Official title: Tolerance of Regular Meal Intake With Mycoprotein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Complication
Keywords: Fermotein™
Gastrointestinal tolerance
Lead sponsor: Wageningen University and Research
Sponsor class: OTHER
Collaborators: name: The Protein Brewery
First posted: 2020-10-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to assess the impact of daily intake of 11 grams of Fermotein™ on gastrointestinal complaints and several other health related biomarkers. Furthermore, consumer acceptance is investigated. The study has a randomized parallel design. Two different treatments will be evaluated e.g. a 18-day intervention with fermotein based meals and a 18-day intervention with control meals. At the start and at the end of the intervention, a blood sample will be collected. 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 the intervention.

Detailed description: Fermotein™ is a mycoprotein, derived from fungi, especially produced for human consumption. It is high in protein, high in fiber, low in saturated fat and contains no cholesterol. Its functional properties and nutrient content makes them ideal to use as an ingredient for meat alternatives and other vegetarian/vegan food products. This study aims to assess the impact of frequent intake of 11 grams of Fermotein™ powder (dry) on gastrointestinal complaints and several other health related biomarkers.

The primary objective is to investigate gastro-intestinal complaints during 18 days of Fermotein™ consumption. The secondary objective is to assess blood based parameters related to general health and consumer acceptance.

The study has a randomized parallel design. Two different treatments will be evaluated e.g. a 18-day intervention with Fermotein™ based meals and a 18-day intervention with control meals. At the start and at the end of the intervention a blood sample will be collected. 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 the intervention.

Eligibility criteria: Inclusion criteria:

* Apparently healthy men and women (based on questionnaire)
* 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), judged by the medical doctor
* 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 over 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 and Health group of Wageningen Food and Biobased Research

Primary outcomes:
measure: Change in gastro intestinal (GI) complaints
timeFrame: Daily, during 18 days of Fermotein™ intake and up to three days after intake.
Secondary outcomes:
measure: change in blood hemoglobin
timeFrame: at baseline, and after 18 days of Fermotein™ or control product consumption
measure: change in blood Fe (iron)
timeFrame: at baseline, and after 18 days of Fermotein™ or control product consumption
measure: change in blood ferritin
timeFrame: at baseline, and after 18 days of Fermotein™ or control product consumption
measure: change in blood insulin
timeFrame: at baseline, and after 18 days of Fermotein™ or control product consumption
measure: change in blood glucose
timeFrame: at baseline, and after 18 days of Fermotein™ or control product consumption
measure: change in blood cholesterol (total)
timeFrame: before and after 18 days consumption of Fermotein™ or control product
measure: change in blood ALAT
timeFrame: at baseline, and after 18 days of Fermotein™ or control product consumption
measure: change in blood ASAT
timeFrame: at baseline, and after 18 days of Fermotein™ or control product consumption
measure: change in blood GGT
timeFrame: at baseline, and after 18 days of Fermotein™ or control product consumption
measure: change in blood leukocyte cell counts
timeFrame: at baseline, and after 18 days of fermotein or control product consumption
measure: change in blood creatinine
timeFrame: at baseline, and after 18 days of Fermotein™ or control product consumption
measure: change in blood zonulin
timeFrame: at baseline, and after 18 days of Fermotein™ or control product consumption
measure: change in blood pressure
timeFrame: at baseline, and after 18 days of Fermotein™ or control product consumption
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Stichting Wageningen Research
state: Gelderland
Study officials:
affiliation: Wageningen University and Research
name: Diederik Esser, PhD
role: PRINCIPAL_INVESTIGATOR
References: