Tolerance of Regular Meal Intake With Mycoprotein (TOMMY)

Wageningen University and Research24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in gastro intestinal (GI) complaints

Determined by combining multiple outcome measures ( bloated feeling, belching, abdominal pain, flatulence, nausea, diarrhoea, constipation) measured via questionnaires with Visual Analogue Scale (VAS) scores; from no complaints (minimal) to serious complaints (maximum). Higher values represent a worse outcome.

Time frame: Daily, during 18 days of Fermotein™ intake and up to three days after intake.