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Completed

NCT Number: NCT05426122

Degree of Digestibility of Barley Rice Proteins

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Barley rice protein concentrate shake

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 concentrate shake

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 concentrate shake

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.

Primary outcomes

  1. Change in degree of digestibility

    Time frame: 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 outcomes

  1. Change in plasma glucose levels

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Wageningen University and Research

Other

Registry information

Acronym: Bar-pro

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2022
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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