Clinical trial NCT05118412: Personal Protein Digestion Variability
Official title: Personal Protein Digestion Variability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digestive System
Keywords: Plant protein
Digestibility
Protein digestion kinetics
Personalized digestibility
Lucerne
Lead sponsor: Wageningen University and Research
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Personal variability in 19 amino acid uptake kinetics
timeFrame: Baseline
measure: Personal variability in 19 amino acid uptake kinetics
timeFrame: 15 minutes post ingestion
measure: Personal variability in 19 amino acid uptake kinetics
timeFrame: 30 minutes post ingestion
measure: Personal variability in 19 amino acid uptake kinetics
timeFrame: 45 minutes post ingestion
measure: Personal variability in 19 amino acid uptake kinetics
timeFrame: 60 minutes post ingestion
measure: Personal variability in 19 amino acid uptake kinetics
timeFrame: 90 minutes post ingestion
measure: Personal variability in 19 amino acid uptake kinetics
timeFrame: 120 minutes post ingestion
measure: Personal variability in 19 amino acid uptake kinetics
timeFrame: 150 minutes post ingestion
measure: Personal variability in 19 amino acid uptake kinetics
timeFrame: 180 minutes post ingestion
measure: Personal variability in 19 amino acid uptake kinetics
timeFrame: 240 minutes post ingestion
Secondary outcomes:
measure: Self-reported gastro-intestinal complaints
timeFrame: Before dinner, at the end of each study day
measure: Self-reported gastro-intestinal complaints
timeFrame: Before dinner, first day after each study day.
measure: Self-reported gastro-intestinal complaints
timeFrame: Before dinner, second day after each study day.
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Stichting Wageningen Research
state: Gelderland
Study officials:
affiliation: Wageningen University and Research
name: Diederik Esser, PhD
role: PRINCIPAL_INVESTIGATOR
References: