Digestibility of Fermotein™

NCT04819789 | Completed

• 1 other identifier: NL74595.081.20
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the degree of digestibility of 3 different Fermotein™ products and compare this to a reference commercially available Mycoprotein (Quorn) and to assess the effects on blood glucose and insulin levels. The study has a randomized, cross-over, double blind, controlled design. Four different treatments, all representing a 20g protein load, will be evaluated with a washout period of minimum one week between the test days. On test days, research subjects will receive a product e.g. Fermotein™ dry, Fermotein™ wet, modified Fermotein™ wet and a reference Mycoprotein (Quorn), in the form of a porridge, in randomized order. Blood will be collected via a catheter before and up-to five hours after protein consumption. Wellbeing, health complaints or other adverse effects will be collected via short questionnaires during each test day. After each test day gastrointestinal complaints are collected via an online questionnaire.

Conditions

Digestive System

Keywords

Fermotein™; Digestibility; Protein digestion kinetics; Mycoprotein

Outcome Measures

Primary Outcomes (1)

• Change in degree of digestibility

  In order to assess change in the degree of digestibility, we determine 19 free amino acids in blood samples collected via a catheter before and at several time points up-to five hours after protein source consumption. Blood amino acids will be determined by the laboratory of Wageningen FBR, according a valid method: AccQ-Tag ultra-derivation kit \& HPLC.

  During the intervention period on 4 test days: at baseline and postprandial blood samples will be collected from the cannula at 10 time points (T=0, 30, 60, 75, 90, 120, 150, 180, 240, 300 minutes).

Secondary Outcomes (2)

• Change in plasma glucose levels

  During the intervention period on 4 test days: at baseline and postprandial blood samples will be collected from the cannula at 9 time points (T=0, 30, 60, 90, 120, 150, 180, 240, 300 minutes).

• Change in plasma insulin levels

  During the intervention period on 4 test days: at baseline and postprandial blood samples will be collected from the cannula at 9 time points (T=0, 30, 60, 90, 120, 150, 180, 240, 300 minutes).

Study Arms (4)

Fermotein™ dry

EXPERIMENTAL

Fermotein™ powder presented in the form of a porridge.

Other: Fermotein™ dry powder porridge

Fermotein™ wet

EXPERIMENTAL

Fermotein™ wet presented in the form of a porridge.

Other: Fermotein™ wet porridge

Fermotein™ modified wet

EXPERIMENTAL

Fermotein™ modified wet presented in the form of a porridge.

Other: Fermotein™ modified wet porridge

Mycoprotein

ACTIVE COMPARATOR

This mycoprotein product presented in the form of a porridge.

Other: Mycoprotein porridge (matching control)

Interventions

Fermotein™ dry powder porridge OTHER

At one out of four test days: Fermotein™ dry powder mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load.

Fermotein™ dry

Fermotein™ wet porridge OTHER

At one out of four test days: Fermotein™ wet mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load.

Fermotein™ wet

Fermotein™ modified wet porridge OTHER

At one out of four test days: Fermotein™ modified wet mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load.

Fermotein™ modified wet

Mycoprotein porridge (matching control) OTHER

At one out of four test days: Mycoprotein (Quorn) mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load.

Also known as: Quorn

Mycoprotein

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;
• Age between 18 and 70 years;
• Body mass index (BMI) between 18.5 and 30 kg/m2 ;
• Having veins suitable for blood sampling via a catheter (judged by study nurse/ medical doctor).

You may not qualify if:

• Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease),or having a condition or disease that may lead to an impaired immune system
• History of gastrointestinal surgery or having (serious) gastrointestinal complaints;
• History of liver dysfunction (cirrhosis, hepatitis) or liver surgery;
• Kidney dysfunction (self-reported);
• Any use of medication that may suppress the immune system, this will be judged by the medical supervisor;
• Use of medication that may influence the study results, such as gastric acid inhibitors, laxatives, stomach protectors and drugs that can affect intestinal motility, this will be judged by the medical supervisor;
• Anaemia (Hb values \<7.5 mmol/L for women and \<8.5 mmol/L for men);
• Reported slimming, medically prescribed or other extreme diets;
• Not willing to give up blood donation during the study;
• Current smokers;
• Alcohol intake ≥4 glasses of alcoholic beverages per day;
• Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported);
• Abuse of hard drugs;
• Having food allergies;
• Not having a general practitioner;

Sponsors & Collaborators

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

Study Sites (1)

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Location

Study Officials

• Diederik Esser, PhD

  Wageningen University and Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project leader clinical trials

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 29, 2021
• Study Start: April 13, 2021
• Primary Completion: May 20, 2021
• Study Completion: May 20, 2021
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)