Clinical Trials Directory

Trials / Completed

CompletedNCT05118412

Personal Protein Digestion Variability

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
18 (actual)
Sponsor
Wageningen University and Research · Academic / Other
Sex
All
Age
18 Years – 40 Years
Healthy volunteers
Accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERLucerne protein concentrate shakeAt three out of five test days: Lucerne protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.
OTHERWhey protein concentrate shakeAt two out of five test days: Whey protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load.

Timeline

Start date
2021-10-26
Primary completion
2021-12-20
Completion
2021-12-20
First posted
2021-11-12
Last updated
2022-01-13

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT05118412. Inclusion in this directory is not an endorsement.