Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05118412
Other study ID # NL 77937.041.21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 26, 2021
Est. completion date December 20, 2021

Study information

Verified date January 2022
Source Wageningen University and Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date December 20, 2021
Est. primary completion date December 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Netherlands Stichting Wageningen Research Wageningen Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Wageningen University and Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Personal variability in 19 amino acid uptake kinetics Plasma 19 free amino acid levels in venous blood samples under fasting conditions. Baseline
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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.
Secondary 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.
See also
  Status Clinical Trial Phase
Completed NCT00671177 - Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique N/A
Completed NCT05426122 - Degree of Digestibility of Barley Rice Proteins N/A
Not yet recruiting NCT06396728 - Use of GI BIOTICS 100B UFC to Improve Intestinal Health in Older Adults N/A
Completed NCT04819789 - Digestibility of Fermotein™ N/A