Tolerance of Regular Meal Intake With Mycoprotein (TOMMY)

• Sponsor: Wageningen University and Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT04590768
• Collaborator: The Protein Brewery (Other)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Days): 21
• Patients Per Site Per Month: 34.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Complication	Other: Fermotein based meals; Other: Matching control meals with whey protein and wheat bran	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Tolerance of Regular Meal Intake With Mycoprotein
• Actual Study Start Date: Oct 12, 2020
• Actual Primary Completion Date: Nov 2, 2020
• Actual Study Completion Date: Nov 2, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. change in blood hemoglobin [at baseline, and after 18 days of Fermotein™ or control product consumption]

   under fasting conditions

2. change in blood Fe (iron) [at baseline, and after 18 days of Fermotein™ or control product consumption]

   under fasting conditions

3. change in blood ferritin [at baseline, and after 18 days of Fermotein™ or control product consumption]

   under fasting conditions

4. change in blood insulin [at baseline, and after 18 days of Fermotein™ or control product consumption]

   under fasting conditions

5. change in blood glucose [at baseline, and after 18 days of Fermotein™ or control product consumption]

   under fasting conditions

6. change in blood cholesterol (total) [before and after 18 days consumption of Fermotein™ or control product]

   under fasting conditions

7. change in blood ALAT [at baseline, and after 18 days of Fermotein™ or control product consumption]

   under fasting conditions

8. change in blood ASAT [at baseline, and after 18 days of Fermotein™ or control product consumption]

   under fasting conditions

9. change in blood GGT [at baseline, and after 18 days of Fermotein™ or control product consumption]

   under fasting conditions

10. change in blood leukocyte cell counts [at baseline, and after 18 days of fermotein or control product consumption]

    under fasting conditions

11. change in blood creatinine [at baseline, and after 18 days of Fermotein™ or control product consumption]

    under fasting conditions

12. change in blood zonulin [at baseline, and after 18 days of Fermotein™ or control product consumption]

    under fasting conditions

13. change in blood pressure [at baseline, and after 18 days of Fermotein™ or control product consumption]

    systolic and diastolic bloodpressure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stichting Wageningen Research	Wageningen	Gelderland	Netherlands	6708 WG

Sponsors and Collaborators

• Wageningen University and Research
• The Protein Brewery

Investigators

• Principal Investigator: Diederik Esser, PhD, Wageningen University and Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Diederik Esser, Principle Investigator, Wageningen University and Research
• ClinicalTrials.gov Identifier: NCT04590768
• Other Study ID Numbers: NL72349.081.19
• First Posted: Oct 19, 2020
• Last Update Posted: Jan 20, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Diederik Esser, Principle Investigator, Wageningen University and Research: Fermotein™; Gastrointestinal tolerance

Study Results

No Results Posted as of Jan 20, 2021