Degree of Digestibility of Barley Rice Proteins

NCT05426122 | Completed

• 1 other identifier: 6239222600
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Digestive System

Keywords

Barley rice protein; Digestibility; Protein digestion kinetics

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 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)

Secondary Outcomes (2)

• 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)

• 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)

Study Arms (3)

Barley rice protein

EXPERIMENTAL

Barley rice protein powder presented as a shake

Other: Barley rice protein concentrate shake

Pea protein

EXPERIMENTAL

Pea protein powder presented as a shake

Other: Pea protein concentrate shake

Whey protein

EXPERIMENTAL

Whey protein powder presented as a shake

Other: Whey protein concentrate shake

Interventions

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.

Barley rice protein

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.

Pea protein

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.

Whey protein

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

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;
• 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);

Sponsors & Collaborators

• Wageningen University and Research: lead

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Investigator)
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project leader clinical trials

Model Details: Crossover Assignment

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: June 9, 2022
• Primary Completion: July 14, 2022
• Study Completion: July 14, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)