Tolerance of Regular Meal Intake With Mycoprotein (TOMMY)

Tolerance of Regular Meal Intake With Mycoprotein

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Complication
• Intervention / Treatment: Other: Fermotein based meals; Other: Matching control meals with whey protein and wheat bran

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708 WG
      • Stichting Wageningen Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fermotein™; daily lunch with 11 grams of Fermotein™ dry powder, mixed in bread, soup or a burger	Other: Fermotein based meals; various meal products: bread, soup and an occasional burgers
ACTIVE_COMPARATOR: Matched control products; daily lunch with a control bread matched in macronutrient content. Control meat alternative burgers and soup from the local supermarket.	Other: Matching control meals with whey protein and wheat bran; various meal products: bread, soup and an occasional burgers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Daily, during 18 days of Fermotein™ intake and up to three days after intake.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in blood hemoglobin	under fasting conditions	at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood Fe (iron)	under fasting conditions	at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood ferritin	under fasting conditions	at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood insulin	under fasting conditions	at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood glucose	under fasting conditions	at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood cholesterol (total)	under fasting conditions	before and after 18 days consumption of Fermotein™ or control product
change in blood ALAT	under fasting conditions	at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood ASAT	under fasting conditions	at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood GGT	under fasting conditions	at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood leukocyte cell counts	under fasting conditions	at baseline, and after 18 days of fermotein or control product consumption
change in blood creatinine	under fasting conditions	at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood zonulin	under fasting conditions	at baseline, and after 18 days of Fermotein™ or control product consumption
change in blood pressure	systolic and diastolic bloodpressure	at baseline, and after 18 days of Fermotein™ or control product consumption

Collaborators and Investigators

• Sponsor: Wageningen University and Research
• Collaborators: The Protein Brewery

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 12, 2020
• Primary Completion (ACTUAL): November 2, 2020
• Study Completion (ACTUAL): November 2, 2020

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Gastrointestinal tolerance; Fermotein™
• Other Study ID Numbers: NL72349.081.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No