Tolerance of Regular Meal Intake With Mycoprotein (TOMMY)

Gastrointestinal Complication Clinical Trial

Official title:

Tolerance of Regular Meal Intake With Mycoprotein

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04590768
• Other study ID #: NL72349.081.19
• Status: Completed
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: November 2, 2020

Study information

• Verified date: January 2021
• Source: Wageningen University and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2, 2020
• Est. primary completion date: November 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Complication

Intervention

Other:
• Fermotein based meals
various meal products: bread, soup and an occasional burgers
• Matching control meals with whey protein and wheat bran
various meal products: bread, soup and an occasional burgers

Locations

Country	Name	City	State
Netherlands	Stichting Wageningen Research	Wageningen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University and Research	The Protein Brewery

Country where clinical trial is conducted

Netherlands, 

Outcome

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