Personal Protein Digestion Variability (DiVa)

This study aims to quantify the variation in postprandial AA profiles between (and within) individuals after consumption of a poorly digestible plant protein source (Lucerne) and to compare the variation in postprandial AA profiles between a poorly digestible plant protein source and an easy digestible protein source (whey).

The study has a randomised, cross-over, controlled design. Two different treatments, all representing a 20g protein load, will be evaluated on five occasions with a washout period of minimum one week between the test days. On test days, research subjects will receive two different protein sources, in the form of a protein drink, in randomised order; on three test days they will receive a poor-digestible protein source, on two test days an easily digestible protein source. Blood will be collected via a catheter before and up-to four 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 will be collected via an online questionnaire.

Study Overview

• Status: Completed
• Conditions: Digestive System
• Intervention / Treatment: Other: Lucerne protein concentrate shake; Other: Whey protein concentrate shake

Detailed Description

There is currently no information on personal protein digestion variability. We recently performed a human intervention study on protein digestibility and absorption and observed that postprandial plasma amino acid (AA) profiles from an easy digestible animal protein were highly comparable among individuals. However, the same profiles from a less digestible plant-protein source (e.g. water lentil) showed a large variability among individuals. But in order to really speak of personalized digestibility, we must be able to demonstrate that the absorption rate of an individual is reproducible. Demonstrating personal differences in AA uptake kinetics will affect the way we value (new) protein sources. Determining and quantifying individual differences in digestion and absorption will allow us to better predict nutritional value of products and diets.

The primary objective is to quantify the variation in postprandial AA profiles between (and within) individuals after consumption of a poorly digestible plant protein source (Lucerne). Secondary objective is to compare the variation in postprandial AA profiles between a poorly digestible plant protein source and an easy digestible protein source (whey).

The study has a randomised, cross-over, controlled design. Two different treatments, all representing a 20g protein load, will be evaluated on five occasions with a washout period of minimum one week between the test days. On test days, research subjects will receive two different protein sources, in the form of a protein drink, in randomised order; on three test days they will receive a poor-digestible protein source, on two test days an easily digestible protein source. Blood will be collected via a catheter before and up-to four 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 will be collected via an online questionnaire.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708 WG
      • Stichting Wageningen Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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;
• 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 or the department of Nutrition and Health of Wageningen University.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lucerne protein concentrate; Lucerne protein concentrate powder presented in the form of a shake.	Other: Lucerne protein concentrate shake; At three out of five test days: Lucerne protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.; Other Names: Alfalfa protein concentrate shake
EXPERIMENTAL: Whey protein concentrate; Whey protein concentrate powder presented in the form of a shake.	Other: Whey protein concentrate shake; At two out of five test days: Whey protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal variability in 19 amino acid uptake kinetics	Plasma 19 free amino acid levels in venous blood samples under fasting conditions.	Baseline
Personal variability in 19 amino acid uptake kinetics	Plasma 19 free amino acid levels in venous blood samples after protein load intake.	15 minutes post ingestion
Personal variability in 19 amino acid uptake kinetics	Plasma 19 free amino acid levels in venous blood samples after protein load intake.	30 minutes post ingestion
Personal variability in 19 amino acid uptake kinetics	Plasma 19 free amino acid levels in venous blood samples after protein load intake.	45 minutes post ingestion
Personal variability in 19 amino acid uptake kinetics	Plasma 19 free amino acid levels in venous blood samples after protein load intake.	60 minutes post ingestion
Personal variability in 19 amino acid uptake kinetics	Plasma 19 free amino acid levels in venous blood samples after protein load intake.	90 minutes post ingestion
Personal variability in 19 amino acid uptake kinetics	Plasma 19 free amino acid levels in venous blood samples after protein load intake.	120 minutes post ingestion
Personal variability in 19 amino acid uptake kinetics	Plasma 19 free amino acid levels in venous blood samples after protein load intake.	150 minutes post ingestion
Personal variability in 19 amino acid uptake kinetics	Plasma 19 free amino acid levels in venous blood samples after protein load intake.	180 minutes post ingestion
Personal variability in 19 amino acid uptake kinetics	Plasma 19 free amino acid levels in venous blood samples after protein load intake.	240 minutes post ingestion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported gastro-intestinal complaints	In order to assess gastro-intestinal complaints, self-reported gastro-intestinal complaints via a online-questionnaire are collected until two days after each test day.	Before dinner, at the end of each study day
Self-reported gastro-intestinal complaints	In order to assess gastro-intestinal complaints, self-reported gastro-intestinal complaints via a online-questionnaire are collected until two days after each test day.	Before dinner, first day after each study day.
Self-reported gastro-intestinal complaints	In order to assess gastro-intestinal complaints, self-reported gastro-intestinal complaints via a online-questionnaire are collected until two days after each test day.	Before dinner, second day after each study day.

Collaborators and Investigators

• Sponsor: Wageningen University and Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 26, 2021
• Primary Completion (ACTUAL): December 20, 2021
• Study Completion (ACTUAL): December 20, 2021

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (ACTUAL): November 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Plant protein; Digestibility; Protein digestion kinetics; Personalized digestibility; Lucerne
• Other Study ID Numbers: NL 77937.041.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No