Lipid MetabolismNCT05313594
Digital Twin - Modelling Postprandial Triglyceride and Glucose Responses
An observational study of Lipid Metabolism and Glucose Metabolism, run by Wageningen University and Research at 1 site in Netherlands.
Trial summary
Giving personalised dietary advice will help mitigate the postprandial increases in TG and glucose levels, and will assist in the battle against the increase in nutrition-related diseases, such as cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism, Glucose Metabolism
- What is being tested?
- Mixed meal challenge test, MRI and DEXA
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Mar 2022to 29 Jun 2022
- Phase
- Observational
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population of the study will consist of generally healthy males and females aged 45-75, with a BMI ranging from 25 to 35 kg/m2. For this study, we will include 38 research subjects (aiming at 50% females).
Who may be able to join
- Male or female
- Age 45-75 y
- BMI 25-35 kg/m2
- Suitable veins for insertion of cannula
Who cannot join
- Having a gastro-intestinal disease, such as celiac disease, Crohn's disease, or Ulcerative colitis
- Having a history of intestinal surgery that might interfere with study outcomes, as determined by the medical supervisor. This does not include an appendectomy or cholecystectomy
- Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease, as determined by the medical supervisor
- Use of medications known to interfere with glucose or lipid homeostasis (e.g. corticosteroids, cholesterol-lowering medication, insulin, metformin), as determined by medical supervisor
- Blood clotting disorders
- Unstable body weight (weight gain or loss >3 kg in the past three months)
Show all 20Show fewer
- Reported slimming, medically prescribed or other extreme diets
- Alcohol consumption >21 glasses a week
- Anaemia (Hb values <7.5 mmol/L for women and <8.5 mmol/L for men; checked at screening)
- Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)
- Having a pacemaker, implantable cardioverter-defibrillator, hearing implant, internal insulin pump, neurostimulator, aneurysm clips placed before 1990, or metal splinter in the eye
- Having claustrophobia
- Not willing to give up blood donation during the study
- Food allergies or intolerances for products that we use in the study
- Unwilling to consume non-vegan test meal
- Recent use of antibiotics (<3 months prior to study start)
- Current smokers
- Abuse of soft and/or hard drugs
- Participation in another clinical trial at the same time
- Being an employee of the Food, Health \& Consumer Research group of Wageningen Food \& Biobased Research or Human Nutrition and Health Department of Wageningen University
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG
About this study
Giving personalised dietary advice will help mitigate the postprandial increases in TG and glucose levels, and will assist in the battle against the increase in nutrition-related diseases, such as cardiovascular diseases. Being able to predict postprandial responses, will be a first step to personalised dietary advice.
The primary objective of this study is to validate the prediction model on the effect of a standardized mixed meal challenge on postprandial TG levels in a heterogenous group of middle-aged, overweight to obese individuals. The secondary objectives are 1) to improve the accuracy of the predicted postprandial TG responses by increasing the number of postprandial TG measurements, 2) to determine which parameters can improve the accuracy of the predicted postprandial TG responses, 3) to determine if we can predict the effect of a standardized mixed meal challenge on postprandial glucose levels in a heterogenous group of middle-aged, overweight to obese individuals, and 4) to determine which parameters can improve the accuracy of the predicted postprandial glucose responses. Another objective is to validate dried blood spots postprandial triglyceride concentrations against venous blood concentrations.
There are minor risks for the research subjects of this study. Research subjects will invest approximately 13.5 hours in the study. They will visit the Wageningen University research facility three times and Hospital Gelderse Vallei once.
Read the detailed description
Elevated triglyceride (TG) and glucose levels are major risk factors for cardiovascular diseases. Therefore, mitigating the postprandial increase in TG and glucose levels may help curb a person's risk of developing cardiovascular diseases. Current strategies to stimulate people to adopt a healthy lifestyle, however, are still insufficient. This is partly due to the fact that nutritional advice is nowadays still given at the population level via general nutrition guidelines, while nutritionist have long been aware that what works for one person may not work for another. Giving personalised dietary advice will help mitigate the postprandial increases in TG and glucose levels, and will assist in the battle against the increase in nutrition-related diseases, such as cardiovascular diseases. Being able to predict postprandial responses, will be a first step to personalised dietary advice.
The primary objective of this study is to validate the prediction model on the effect of a standardized mixed meal challenge on postprandial TG levels in a heterogenous group of middle-aged, overweight to obese individuals. The secondary objectives are 1) to improve the accuracy of the predicted postprandial TG responses by increasing the number of postprandial TG measurements, 2) to determine which parameters can improve the accuracy of the predicted postprandial TG responses, 3) to determine if we can predict the effect of a standardized mixed meal challenge on postprandial glucose levels in a heterogenous group of middle-aged, overweight to obese individuals, and 4) to determine which parameters can improve the accuracy of the predicted postprandial glucose responses. Another objective is to validate dried blood spots postprandial triglyceride concentrations against venous blood concentrations.
Digital twin is an observational study with three visits, including one mixed meal challenge test day.
Study population consists of 38 volunteers, 45-75 year old, BMI between 25-35 kg/m2.
The primary study parameter is the postprandial triglyceride responses in blood upon a mixed meal challenge. The secondary study parameters are: postprandial responses in the blood upon a mixed meal challenge, and extensive phenotyping of the subjects by collecting data on fasting blood profiles of micronutrients, metabolites, and proteins, continuous blood glucose levels (Freestyle Libre), body fat composition (DEXA), liver fat percentage (MRI), habitual dietary intake (FFQ), and physical activity (ActivPAL3).
This study is related to a broad general population. There are minor risks for the research subjects of this study. Consumption of the liquid mixed meal may cause some gastro-intestinal discomfort. Blood sampling will be performed via a cannula and the insertion can be a bit painful and may cause a bruise. The amount of blood that is drawn from subjects is within acceptable limits (total amount collected = 186mL). The radiation dose received during the DEXA scan for measuring body composition, is negligible compared to the average dose each person in the Netherlands receives per year. Research subjects will invest approximately 13.5 hours in the study. They will visit the Wageningen University research facility three times: once for a short screening, once to collect phenotyping data, and once for a mixed-meal challenge test day. In addition, they will visit Hospital Gelderse Vallei once for an MRI measurement.
- Conditions
- Lipid Metabolism, Glucose Metabolism
- Being tested
- Mixed meal challenge test, MRI, DEXA, Freestyle Libre, ActivPAL3
- Keywords
- postprandial, lipids, glucose, dried blood spot, prediction model, metabolic responses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed meal challenge testDiagnostic test
Mixed meal consumption followed by postprandial blood sampling
MRIDiagnostic test
MRI imaging
DEXADiagnostic test
DEXA scan
Freestyle LibreDevice
Continuous blood glucose measurement
ActivPAL3Device
Continuous physical activity measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: Baseline
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 15 minutes post-ingestion
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 30 minutes post-ingestion
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 45 minutes post-ingestion
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 60 minutes post-ingestion
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 90 minutes post-ingestion
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 120 minutes post-ingestion
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 150 minutes post-ingestion
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 180 minutes post-ingestion
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 210 minutes post-ingestion
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 240 minutes post-ingestion
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 270 minutes post-ingestion
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 300 minutes post-ingestion
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 330 minutes post-ingestion
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 360 minutes post-ingestion
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 390 minutes post-ingestion
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 420 minutes post-ingestion
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 450 minutes post-ingestion
Postprandial triglycerides blood levels
Postprandial triglyceride responses in blood upon a mixed meal challenge
Measured: 480 minutes post-ingestion
Secondary outcomes (23)
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: Baseline
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: 15 minutes post-ingestion
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: 30 minutes post-ingestion
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: 45 minutes post-ingestion
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: 60 minutes post-ingestion
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: 90 minutes post-ingestion
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: 120 minutes post-ingestion
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: 150 minutes post-ingestion
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: 180 minutes post-ingestion
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: 210 minutes post-ingestion
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: 240 minutes post-ingestion
Postprandial glucose blood levels
Postprandial glucose responses in blood upon a mixed meal challenge
Measured: 480 minutes post-ingestion
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: Baseline
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: 15 minutes post-ingestion
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: 30 minutes post-ingestion
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: 60 minutes post-ingestion
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: 90 minutes post-ingestion
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: 120 minutes post-ingestion
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: 150 minutes post-ingestion
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: 180 minutes post-ingestion
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: 210 minutes post-ingestion
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: 240 minutes post-ingestion
Postprandial insulin blood levels
Postprandial insulin responses in blood upon a mixed meal challenge
Measured: 480 minutes post-ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start28 Mar 2022
- Primary completion14 Jun 2022
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid MetabolismStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 38 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 J Esser, PhD, Principal investigator, Wageningen University & Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313594
- Sponsor's protocol ID
- NL79685.091.21
- Status last verified
- Jul 2022
- First submitted
- 15 Mar 2022
- Last updated
- 6 Jul 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 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Twin - Modelling Postprandial Triglyceride and Glucose Responses
- ClinicalTrials.gov ID
- NCT05313594
- Acronym / sponsor ID
- NL79685.091.21
- Conditions
- Lipid Metabolism, Glucose Metabolism
- Keywords
- postprandial, lipids, glucose, dried blood spot, prediction model, metabolic responses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 6 Apr 2022 (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.
Giving personalised dietary advice will help mitigate the postprandial increases in TG and glucose levels, and will assist in the battle against the increase in nutrition-related diseases, such as cardiovascular diseases. Being able to predict postprandial responses, will be a first step to personalised dietary advice.
The primary objective of this study is to validate the prediction model on the effect of a standardized mixed meal challenge on postprandial TG levels in a heterogenous group of middle-aged, overweight to obese individuals. The secondary objectives are 1) to improve the accuracy of the predicted postprandial TG responses by increasing the number of postprandial TG measurements, 2) to determine which parameters can improve the accuracy of the predicted postprandial TG responses, 3) to determine if we can predict the effect of a standardized mixed meal challenge on postprandial glucose levels in a heterogenous group of middle-aged, overweight to obese individuals, and 4) to determine which parameters can improve the accuracy of the predicted postprandial glucose responses. Another objective is to validate dried blood spots postprandial triglyceride concentrations against venous blood concentrations.
There are minor risks for the research subjects of this study. Research subjects will invest approximately 13.5 hours in the study. They will visit the Wageningen University research facility three times and Hospital Gelderse Vallei once.
Detailed description
Elevated triglyceride (TG) and glucose levels are major risk factors for cardiovascular diseases. Therefore, mitigating the postprandial increase in TG and glucose levels may help curb a person's risk of developing cardiovascular diseases. Current strategies to stimulate people to adopt a healthy lifestyle, however, are still insufficient. This is partly due to the fact that nutritional advice is nowadays still given at the population level via general nutrition guidelines, while nutritionist have long been aware that what works for one person may not work for another. Giving personalised dietary advice will help mitigate the postprandial increases in TG and glucose levels, and will assist in the battle against the increase in nutrition-related diseases, such as cardiovascular diseases. Being able to predict postprandial responses, will be a first step to personalised dietary advice.
The primary objective of this study is to validate the prediction model on the effect of a standardized mixed meal challenge on postprandial TG levels in a heterogenous group of middle-aged, overweight to obese individuals. The secondary objectives are 1) to improve the accuracy of the predicted postprandial TG responses by increasing the number of postprandial TG measurements, 2) to determine which parameters can improve the accuracy of the predicted postprandial TG responses, 3) to determine if we can predict the effect of a standardized mixed meal challenge on postprandial glucose levels in a heterogenous group of middle-aged, overweight to obese individuals, and 4) to determine which parameters can improve the accuracy of the predicted postprandial glucose responses. Another objective is to validate dried blood spots postprandial triglyceride concentrations against venous blood concentrations.
Digital twin is an observational study with three visits, including one mixed meal challenge test day.
Study population consists of 38 volunteers, 45-75 year old, BMI between 25-35 kg/m2.
The primary study parameter is the postprandial triglyceride responses in blood upon a mixed meal challenge. The secondary study parameters are: postprandial responses in the blood upon a mixed meal challenge, and extensive phenotyping of the subjects by collecting data on fasting blood profiles of micronutrients, metabolites, and proteins, continuous blood glucose levels (Freestyle Libre), body fat composition (DEXA), liver fat percentage (MRI), habitual dietary intake (FFQ), and physical activity (ActivPAL3).
This study is related to a broad general population. There are minor risks for the research subjects of this study. Consumption of the liquid mixed meal may cause some gastro-intestinal discomfort. Blood sampling will be performed via a cannula and the insertion can be a bit painful and may cause a bruise. The amount of blood that is drawn from subjects is within acceptable limits (total amount collected = 186mL). The radiation dose received during the DEXA scan for measuring body composition, is negligible compared to the average dose each person in the Netherlands receives per year. Research subjects will invest approximately 13.5 hours in the study. They will visit the Wageningen University research facility three times: once for a short screening, once to collect phenotyping data, and once for a mixed-meal challenge test day. In addition, they will visit Hospital Gelderse Vallei once for an MRI measurement.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the study will consist of generally healthy males and females aged 45-75, with a BMI ranging from 25 to 35 kg/m2. For this study, we will include 38 research subjects (aiming at 50% females).
Key inclusion criteria (4 listed)
- Male or female
- Age 45-75 y
- BMI 25-35 kg/m2
- Suitable veins for insertion of cannula
Key exclusion criteria (20 listed)
- Having a gastro-intestinal disease, such as celiac disease, Crohn's disease, or Ulcerative colitis
- Having a history of intestinal surgery that might interfere with study outcomes, as determined by the medical supervisor. This does not include an appendectomy or cholecystectomy
- Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease, as determined by the medical supervisor
- Use of medications known to interfere with glucose or lipid homeostasis (e.g. corticosteroids, cholesterol-lowering medication, insulin, metformin), as determined by medical supervisor
- Blood clotting disorders
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 |
|---|---|---|
| Mixed meal challenge testMixed meal consumption followed by postprandial blood sampling | Diagnostic test | – |
| MRIMRI imaging | Diagnostic test | – |
| DEXADEXA scan | Diagnostic test | – |
| Freestyle LibreContinuous blood glucose measurement | Device | – |
| ActivPAL3Continuous physical activity measurement | Device | – |
Primary outcome
Postprandial triglycerides blood levels
Time frame: Baseline
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 15 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 30 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 45 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 60 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 90 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 120 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 150 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 180 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 210 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 240 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 270 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 300 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 330 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 360 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 390 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 420 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 450 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
Postprandial triglycerides blood levels
Time frame: 480 minutes post-ingestion
Postprandial triglyceride responses in blood upon a mixed meal challenge
23 secondary outcomes
Postprandial glucose blood levels
Time frame: Baseline
Postprandial glucose blood levels
Time frame: 15 minutes post-ingestion
Postprandial glucose blood levels
Time frame: 30 minutes post-ingestion
Postprandial glucose blood levels
Time frame: 45 minutes post-ingestion
Postprandial glucose blood levels
Time frame: 60 minutes post-ingestion
Postprandial glucose blood levels
Time frame: 90 minutes post-ingestion
Postprandial glucose blood levels
Time frame: 120 minutes post-ingestion
Postprandial glucose blood levels
Time frame: 150 minutes post-ingestion
Postprandial glucose blood levels
Time frame: 180 minutes post-ingestion
Postprandial glucose blood levels
Time frame: 210 minutes post-ingestion
Postprandial glucose blood levels
Time frame: 240 minutes post-ingestion
Postprandial glucose blood levels
Time frame: 480 minutes post-ingestion
Postprandial insulin blood levels
Time frame: Baseline
Postprandial insulin blood levels
Time frame: 15 minutes post-ingestion
Postprandial insulin blood levels
Time frame: 30 minutes post-ingestion
Postprandial insulin blood levels
Time frame: 60 minutes post-ingestion
Postprandial insulin blood levels
Time frame: 90 minutes post-ingestion
Postprandial insulin blood levels
Time frame: 120 minutes post-ingestion
Postprandial insulin blood levels
Time frame: 150 minutes post-ingestion
Postprandial insulin blood levels
Time frame: 180 minutes post-ingestion
Postprandial insulin blood levels
Time frame: 210 minutes post-ingestion
Postprandial insulin blood levels
Time frame: 240 minutes post-ingestion
Postprandial insulin blood levels
Time frame: 480 minutes post-ingestion
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 6 Jul 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 J Esser, PhD principal investigator
Wageningen University & Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipid Metabolism and Glucose Metabolism, 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 20 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 6 Jul 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?
Postprandial triglycerides blood levels (time frame: Baseline). The study lists 19 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 6 Jul 2022; AzTrials last refreshed its copy on 31 Oct 2026.