Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG, Netherlands
NCT Number: NCT05118412
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.
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Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Wageningen, Gelderland, 6708 WG, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: Baseline
Plasma 19 free amino acid levels in venous blood samples under fasting conditions.
Time frame: 15 minutes post ingestion
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Time frame: 30 minutes post ingestion
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Time frame: 45 minutes post ingestion
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Time frame: 60 minutes post ingestion
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Time frame: 90 minutes post ingestion
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Time frame: 120 minutes post ingestion
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Time frame: 150 minutes post ingestion
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Time frame: 180 minutes post ingestion
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Time frame: 240 minutes post ingestion
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Time frame: Before dinner, at the end of each study day
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.
Time frame: Before dinner, first day after each study day.
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.
Time frame: Before dinner, second day after each study day.
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.
Wageningen University and Research
Other
Acronym: DiVa
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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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