Tolerance of Regular Meal Intake With Mycoprotein (TOMMY)

NCT04590768 | Completed

• 1 other identifier: NL72349.081.19
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Complication

Keywords

Fermotein™; Gastrointestinal tolerance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• change in blood hemoglobin

  at baseline, and after 18 days of Fermotein™ or control product consumption

• change in blood Fe (iron)

  at baseline, and after 18 days of Fermotein™ or control product consumption

• change in blood ferritin

  at baseline, and after 18 days of Fermotein™ or control product consumption

• change in blood insulin

  at baseline, and after 18 days of Fermotein™ or control product consumption

• change in blood glucose

  at baseline, and after 18 days of Fermotein™ or control product consumption

Study Arms (2)

Fermotein™

EXPERIMENTAL

daily lunch with 11 grams of Fermotein™ dry powder, mixed in bread, soup or a burger

Other: Fermotein based meals

Matched control products

ACTIVE COMPARATOR

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

Interventions

Fermotein based meals OTHER

various meal products: bread, soup and an occasional burgers

Fermotein™

Matching control meals with whey protein and wheat bran OTHER

various meal products: bread, soup and an occasional burgers

Matched control products

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University and Research: lead
• The Protein Brewery: collaborator

Study Sites (1)

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Location

MeSH Terms

Interventions

Whey Proteins; Dietary Fiber

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Carbohydrates; Carbohydrates

Study Officials

• Diederik Esser, PhD

  Wageningen University and Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: October 19, 2020
• Study Start: October 12, 2020
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)