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Tolerance of Regular Meal Intake With Mycoprotein (TOMMY)

NCT04590768 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-01-20

No results posted yet for this study

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.

Conditions

  • Gastrointestinal Complication

Interventions

OTHER

Fermotein based meals

various meal products: bread, soup and an occasional burgers

OTHER

Matching control meals with whey protein and wheat bran

various meal products: bread, soup and an occasional burgers

Sponsors & Collaborators

  • The Protein Brewery

    collaborator UNKNOWN

  • Wageningen University and Research

    lead OTHER

Principal Investigators

  • Diederik Esser, PhD · Wageningen University and Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-12
Primary Completion
2020-11-02
Completion
2020-11-02

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04590768 on ClinicalTrials.gov