Bar-pro: Degree of Digestibility of Barley Rice Proteins

Sponsor
Wageningen University and Research (Other)
Overall Status
Completed
CT.gov ID
NCT05426122
Collaborator
(none)
12
1
3
1.1
10.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Barley rice protein concentrate shake
  • Other: Pea protein concentrate shake
  • Other: Whey protein concentrate shake
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Crossover AssignmentCrossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Degree of Digestibility of Barley Rice Proteins
Actual Study Start Date :
Jun 9, 2022
Actual Primary Completion Date :
Jul 14, 2022
Actual Study Completion Date :
Jul 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Barley rice protein

Barley rice protein powder presented as a shake

Other: 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.

Experimental: Pea protein

Pea protein powder presented as a shake

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.

Experimental: Whey protein

Whey protein powder presented as a shake

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.

Outcome Measures

Primary Outcome Measures

  1. Change in degree of digestibility [During the intervention period on 3 test days: at baseline and postprandial blood samples will be collected from the cannula at 10 time points (T=0, 30, 45, 60, 90, 120, 150, 180, 240, 300 minutes)]

    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.

Secondary Outcome Measures

  1. Change in plasma glucose levels [During the intervention period on 3 test days: at baseline and postprandial blood samples will be collected from the cannula at 10 time points (T=0, 30, 45, 60, 90, 120, 150, 180, 240, 300 minutes)]

    Plasma glucose levels will be determined in blood samples collected via a catheter before and at several time points up-to five hours after protein source consumption (hospital laboratory Ziekenhuis Gelderse vallei, Ede, the Netherlands)

  2. Change in plasma insulin levels [During the intervention period on 3 test days: at baseline and postprandial blood samples will be collected from the cannula at 10 time points (T=0, 30, 45, 60, 90, 120, 150, 180, 240, 300 minutes)]

    Plasma insulin levels will be determined in blood samples collected via a catheter before and at several time points up-to five hours after protein source consumption (hospital laboratory Ziekenhuis Gelderse vallei, Ede, the Netherlands).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

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

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, Project leader clinical trials, Wageningen University and Research
ClinicalTrials.gov Identifier:
NCT05426122
Other Study ID Numbers:
  • 6239222600
First Posted:
Jun 21, 2022
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022
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, Project leader clinical trials, Wageningen University and Research

Study Results

No Results Posted as of Jul 18, 2022