Primary Objective: To quantify the variation in post-prandial plasma AA profiles between (and within) individuals after consumption of a poorly digestible plant protein source (lucerne). Secondary Objective: To compare the variation in postprandial…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
opname van eiwitten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is AA uptake kinetics e.g. the appearance of free
amino acids in blood samples collected before and after consumption. We will
determine and quantify between, and within-subject variability.
Secondary outcome
GI complaints via questionnaire
Background summary
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.
Study objective
Primary Objective: To quantify the variation in post-prandial plasma AA
profiles between (and within) individuals after consumption of a poorly
digestible plant protein source (lucerne). Secondary Objective: To compare the
variation in postprandial AA profiles between a poorly digestible plant protein
source and an easy digestible protein source (whey).
Study design
The study has a randomised, cross-over, controlled design. Two different
treatments will be evaluated on five occasions with a washout period of minimum
one week between the test days. We will provide participants two different
protein sources; on three test days they will receive a poor-digestible protein
source, on two test days an easily digestible protein source. On test days,
research subjects will receive a product in the form of a protein drink, in
randomised order. Blood will be collected via a catheter before and up-to five
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 are collected via an online
questionnaire.
Intervention
Research subjects will receive two times an easy digestible protein source wey
and three times a poorly digestible protein source lucerne. Both representing a
20g protein load.
Study burden and risks
This study is not related to a specific group. There are minor risks for the
research subjects of this study. There are no direct benefits for the research
subjects. The total amount of blood collected (430 ml ) is spread over 6 weeks
and we will exclude subjects with anaemia. Blood collection will therefore not
be expected to cause any problems. Research subjects that will participate in
the study will invest approximately 27 hours during the trial.
Bornse Weilanden 9
Wageningen 6708 WG
NL
Bornse Weilanden 9
Wageningen 6708 WG
NL
Listed location countries
Age
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;
* 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL77937.041.21 |
| Other | proces loopt |