Tolerance of Regular Meal Intake With Mycoprotein (TOMMY)

Wageningen University and Research

Status

Completed

Conditions

Gastrointestinal Complication

Treatments

Other: Matching control meals with whey protein and wheat bran

Other: Fermotein based meals

Study type

Interventional

Funder types

Other

Identifiers

NCT04590768

NL72349.081.19

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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