Degree of Digestibility of Barley Rice Proteins

NCT ID: NCT05426122

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-09
• Study Completion Date: 2022-07-14

Brief Summary

This study aims to assess the degree of digestibility of barley rice protein and compare this to another sustainable, commercially available protein concentrate (pea protein), and a benchmark whey protein, and to assess the effects on blood glucose and insulin levels.

The study is a randomized, cross-over, double blind, controlled trial. Three different treatments, all representing a 20g protein load, will be evaluated with a washout period of minimum one week between the test days. 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 a short questionnaire during each test day. After each test day gastrointestinal complaints are collected via an online questionnaire.

Detailed Description

Barley rice protein is extracted from brewer spent grains (BSG), which is the most voluminous by-product of the brewing industry. Until now, BSG has been mainly used for animal feed or is directly discarded, which is an enormous waste of resources and causes serious environmental pollution. BSG is rich in cellulose and non-cellulosic polysaccharides, lignin, and proteins. The protein fraction of BSG contains a relatively high content of the essential amino acid, lysine, in comparison to other cereal products. Because of its high nutritional content, BSG can be applied in human food products for fortification. The digestion characteristics of barley rice protein are not known, but essential to evaluate their future potential as a sustainable protein source.

The primary objective is to estimate the degree of digestibility of barley rice protein by measuring post-prandial amino acid uptake kinetics, and compare this to pea protein and a benchmark protein (whey).

Secondary objectives are to assess the effects on blood glucose and insulin levels.

The study is a randomized, cross-over, double blind, controlled trial. Three different treatments, all representing a 20g protein load, will be evaluated with a washout period of minimum one week between the test days. 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 a short questionnaire during each test day. After each test day gastrointestinal complaints are collected via an online questionnaire.

Conditions

Digestive System

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Barley rice protein

Barley rice protein powder presented as a shake

Group Type: EXPERIMENTAL

Barley rice protein concentrate shake

Intervention Type: OTHER

At one out of three test days barley rice protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.

Pea protein

Pea protein powder presented as a shake

Group Type: EXPERIMENTAL

Pea protein concentrate shake

Intervention Type: OTHER

At one out of three test days pea protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.

Whey protein

Whey protein powder presented as a shake

Group Type: EXPERIMENTAL

Whey protein concentrate shake

Intervention Type: OTHER

At one out of three test days whey protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.

Interventions

Barley rice protein concentrate shake

At one out of three test days barley rice protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.

Intervention Type: OTHER

Pea protein concentrate shake

At one out of three test days pea protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.

Intervention Type: OTHER

Whey protein concentrate shake

At one out of three test days whey protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Apparently healthy men and women;
• Age between 18 and 40 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).

Exclusion Criteria

• 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;
• Use of protein supplements;
• 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 and/or intolerances (e.g. for gluten);
• Not having a general practitioner;
• Participation in another clinical trial at the same time;
• Being an employee of the department Food, Health & Consumer Research of Wageningen Food & Biobased Research.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wageningen University and Research

OTHER

Sponsor Role: lead

Responsible Party

Diederik Esser

Project leader clinical trials

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diederik Esser, PhD

Role: PRINCIPAL_INVESTIGATOR

Wageningen University and Research

Locations

Stichting Wageningen Research

Wageningen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

6239222600

Identifier Type: -

Identifier Source: org_study_id