Tolerance of Regular Meal Intake With Mycoprotein (TOMMY)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tolerance of Regular Meal Intake With Mycoprotein

Conditions
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Gastrointestinal Complication

Intervention / Treatment
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* Other: Fermotein based meals
* Other: Matching control meals with whey protein and wheat bran


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fermotein™<br>daily lunch with 11 grams of Fermotein™ dry powder, mixed in bread, soup or a burger | Other: Fermotein based meals<br>* various meal products: bread, soup and an occasional burgers<br>|
| Active Comparator: Matched control products<br>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<br>* various meal products: bread, soup and an occasional burgers<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fermotein™, Gastrointestinal tolerance