Tolerance of Regular Meal Intake With Mycoprotein (TOMMY)

Not Applicable

Completed

• Conditions: Gastrointestinal Complication
• Interventions: Other: Matching control meals with whey protein and wheat bran; Other: Fermotein based meals

• Registration Number: NCT04590768
• Lead Sponsor: Wageningen University and Research

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.

Study Timeline

• Study First Submitted: 2020-09-10
• Study Start: 2020-10-12
• Study First Submitted QC: 2020-10-12
• Study First Posted: 2020-10-19
• Primary Completion: 2020-11-02
• Study Completion: 2020-11-02
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-18
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matched control products	Matching control meals with whey protein and wheat bran	daily lunch with a control bread matched in macronutrient content. Control meat alternative burgers and soup from the local supermarket.
Fermotein™	Fermotein based meals	daily lunch with 11 grams of Fermotein™ dry powder, mixed in bread, soup or a burger

Primary Outcome Measures

Name	Time	Method
Change in gastro intestinal (GI) complaints	Daily, during 18 days of Fermotein™ intake and up to three days after intake.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stichting Wageningen Research; 🇳🇱 Wageningen, Gelderland, Netherlands