Digestive SystemDiVaNCT05118412
Personal Protein Digestion Variability
A study testing Lucerne protein concentrate shake and Whey protein concentrate shake in people with Digestive System, run by Wageningen University and Research at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive System
- What is being tested?
- Lucerne protein concentrate shake and Whey protein concentrate shake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Oct 2021to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG
About this study
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.
Read the 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.
- Conditions
- Digestive System
- Being tested
- Lucerne protein concentrate shake, Whey protein concentrate shake
- Keywords
- Plant protein, Digestibility, Protein digestion kinetics, Personalized digestibility, Lucerne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lucerne protein concentrate shakeOther
Also called Alfalfa 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 shakeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lucerne protein concentrate | Experimental | Lucerne protein concentrate powder presented in the form of a shake. Receives: Other: Lucerne protein concentrate shake |
| Whey protein concentrate | Experimental | Whey protein concentrate powder presented in the form of a shake. Receives: Other: Whey protein concentrate shake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal variability in 19 amino acid uptake kinetics
Plasma 19 free amino acid levels in venous blood samples under fasting conditions.
Measured: Baseline
Personal variability in 19 amino acid uptake kinetics
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Measured: 15 minutes post ingestion
Personal variability in 19 amino acid uptake kinetics
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Measured: 30 minutes post ingestion
Personal variability in 19 amino acid uptake kinetics
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Measured: 45 minutes post ingestion
Personal variability in 19 amino acid uptake kinetics
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Measured: 60 minutes post ingestion
Personal variability in 19 amino acid uptake kinetics
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Measured: 90 minutes post ingestion
Personal variability in 19 amino acid uptake kinetics
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Measured: 120 minutes post ingestion
Personal variability in 19 amino acid uptake kinetics
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Measured: 150 minutes post ingestion
Personal variability in 19 amino acid uptake kinetics
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Measured: 180 minutes post ingestion
Personal variability in 19 amino acid uptake kinetics
Plasma 19 free amino acid levels in venous blood samples after protein load intake.
Measured: 240 minutes post ingestion
Secondary outcomes (3)
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.
Measured: Before dinner, at the end of each study day
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.
Measured: Before dinner, first day after each study day.
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.
Measured: Before dinner, second day after each study day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start26 Oct 2021
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diederik Esser, Wageningen University and Research
- Investigators
- Diederik Esser, PhD, Principal investigator, Wageningen University and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118412
- Sponsor's protocol ID
- NL 77937.041.21
- Acronym
- DiVa
- Status last verified
- Jan 2022
- First submitted
- 29 Oct 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Protein Digestion Variability
- ClinicalTrials.gov ID
- NCT05118412
- Acronym / sponsor ID
- DiVa / NL 77937.041.21
- Conditions
- Digestive System
- Keywords
- Plant protein, Digestibility, Protein digestion kinetics, Personalized digestibility, Lucerne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 12 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lucerne protein concentrate | Experimental | Other: Lucerne protein concentrate shakeLucerne protein concentrate powder presented in the form of a shake. |
| Whey protein concentrate | Experimental | Other: Whey protein concentrate shakeWhey protein concentrate powder presented in the form of a shake. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lucerne protein concentrate shakeAlso: Alfalfa protein concentrate shakeAt 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 | Lucerne protein concentrate |
| Whey protein concentrate shakeAt two out of five test days: Whey protein concentrate powder will be mixed with water to obtain a shake, representing a 20g protein load. | Other | Whey protein concentrate |
Primary outcome
Personal variability in 19 amino acid uptake kinetics
Time frame: Baseline
Plasma 19 free amino acid levels in venous blood samples under fasting conditions.
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.
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.
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Self-reported gastro-intestinal complaints
Time frame: Before dinner, at the end of each study day
Self-reported gastro-intestinal complaints
Time frame: Before dinner, first day after each study day.
Self-reported gastro-intestinal complaints
Time frame: Before dinner, second day after each study day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diederik Esser, PhD principal investigator
Wageningen University and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lucerne protein concentrate shake and Whey protein concentrate shake in people with Digestive System, run by Wageningen University and Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal variability in 19 amino acid uptake kinetics (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.