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Completed

NCT Number: NCT05118412

Personal Protein Digestion Variability

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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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lucerne protein concentrate shake

Other

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

Whey protein concentrate shake

Other

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.

Primary outcomes

  1. Personal variability in 19 amino acid uptake kinetics

    Time frame: Baseline

    Plasma 19 free amino acid levels in venous blood samples under fasting conditions.

  2. Personal variability in 19 amino acid uptake kinetics

    Time frame: 15 minutes post ingestion

    Plasma 19 free amino acid levels in venous blood samples after protein load intake.

  3. Personal variability in 19 amino acid uptake kinetics

    Time frame: 30 minutes post ingestion

    Plasma 19 free amino acid levels in venous blood samples after protein load intake.

  4. Personal variability in 19 amino acid uptake kinetics

    Time frame: 45 minutes post ingestion

    Plasma 19 free amino acid levels in venous blood samples after protein load intake.

  5. Personal variability in 19 amino acid uptake kinetics

    Time frame: 60 minutes post ingestion

    Plasma 19 free amino acid levels in venous blood samples after protein load intake.

  6. Personal variability in 19 amino acid uptake kinetics

    Time frame: 90 minutes post ingestion

    Plasma 19 free amino acid levels in venous blood samples after protein load intake.

  7. Personal variability in 19 amino acid uptake kinetics

    Time frame: 120 minutes post ingestion

    Plasma 19 free amino acid levels in venous blood samples after protein load intake.

  8. Personal variability in 19 amino acid uptake kinetics

    Time frame: 150 minutes post ingestion

    Plasma 19 free amino acid levels in venous blood samples after protein load intake.

  9. Personal variability in 19 amino acid uptake kinetics

    Time frame: 180 minutes post ingestion

    Plasma 19 free amino acid levels in venous blood samples after protein load intake.

  10. Personal variability in 19 amino acid uptake kinetics

    Time frame: 240 minutes post ingestion

    Plasma 19 free amino acid levels in venous blood samples after protein load intake.

Secondary outcomes

  1. Self-reported gastro-intestinal complaints

    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.

  2. Self-reported gastro-intestinal complaints

    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.

  3. Self-reported gastro-intestinal complaints

    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.

Sponsors and collaborators

Lead sponsor

Wageningen University and Research

Other

Registry information

Acronym: DiVa

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 12, 2021
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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