GenomicsPOEMINCT04178681
Postprandial Effects of Milk Fats
A study testing 100% vegetable blend, 100% AMF and 100% cream in people with Genomics and Postprandial Metabolism, run by Wageningen University at 1 site in Netherlands.
Trial summary
Nowadays, mostly vegetable fat blends are used in infant formula, but the use of bovine milk fat is increasing. In terms of fat structure, bovine milk fat and vegetable fats differ. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Genomics, Postprandial Metabolism, Nutrition
- What is being tested?
- 100% vegetable blend, 100% AMF and 100% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Dec 2019to 28 Feb 2020
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy man or woman
- Age 40-70y at the time of recruitment
- BMI of 22-27 kg/m2
- Having a Hb value above 8.4 (men) or 7.4 (women) mmol/L (will be checked at the screening visit)
- Having veins suitable for blood sampling via a catheter cannula (judged by study nurse/ medical doctor)
- Having a general practitioner
- Signed informed consent
Who cannot join
- Any chronic metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease)
- History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
- Renal or hepatic malfunctioning (pre-diagnosis or determined based on ALAT, ASAT and creatinine values)
- Use of medication that may influence the study results, such as laxatives, stomach protectors and drugs that can affect intestinal motility.
- Donated or intend to donate blood from 2 months before the study until the end of the study
- Reported slimming, medically prescribed or vegan diet
Show all 16Show fewer
- Unstable body weight (weight gain or loss >5 kg in the past three months)
- Current smokers
- Alcohol on average: more than 2 consumptions/day or more than 14 consumptions/week
- Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)
- Use of illicit drugs
- Food allergies for products that the investigators use in the study
- Participation in another clinical trial at the same time, or in the month preceding the start of this study
- Inability to understand study information and/or communicate with staff
- Members of the research team
- Working, or doing an internship or thesis at the division "Human Nutrition and Health", Wageningen University
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Wageningen University, Division of Human Nutrition
Wageningen, Gelderland, 6700 EV
Lydia A Afman, PhD, 0031317485789, lydia.afman@wur.nl
About this study
Official title: The Effects of Different Fat Structures on Postprandial Responses in Healthy Subjects
Nowadays, mostly vegetable fat blends are used in infant formula, but the use of bovine milk fat is increasing. In terms of fat structure, bovine milk fat and vegetable fats differ. Bovine milk fat has a higher percentage of palmitic acid attached to the sn-2 position of the glycerol backbone compared to vegetable fat blend. Also bovine milk fat contains milk fat globular membranes, as opposed to vegetable fat. With this study the investigators want to examine the effects of a vegetable fat blend versus bovine milk fat without globular membranes and bovine milk fat with globular membranes on underlying mechanistic, immune and metabolic responses.
Read the detailed description
Rationale: Human milk is considered as the ideal food for full-term infants. The composition and function of human milk is unique and has provided the basis for the development of modern artificial milk formulas that mimic its complex biological positive effects on infants and can provide an appropriate substitute for non-breastfed infants. An important component in human milk are the lipids, as they deliver 50% of the total energy to infants. Nowadays, mostly vegetable fat blends are used in infant formula, but the use of bovine milk fat is increasing. In terms of fat structure, bovine milk fat and vegetable fats differ. Bovine milk fat has a higher percentage of palmitic acid attached to the sn-2 position of the glycerol backbone compared to vegetable fat blend. Also bovine milk fat contains milk fat globular membranes, as opposed to vegetable fat. Knowledge on how these differences influence underlying mechanistic, immune and metabolic responses is lacking.
Objectives: The primary objective of this study is to determine the effect of three different fat blends on underlying mechanistic and immune responses in the circulation. The secondary objectives of this study are: 1) to examine the effects of the three different fat blends on postprandial triglyceride concentration and other cardio-metabolic markers in the circulation, 2) to investigate the effect of the three different fat blends on postprandial feelings of hunger and satiety, and 3) to investigate how comparable cytokine measurements are in blood samples obtained via a catheter cannula compared to cytokine measurements in dried blood spots obtained via a finger prick.
Study design: The POEMI Study is a double-blind randomized cross-over acute intervention study in which each research subject will visit the university on three separate occasions with a wash-out period of at least one week. At each visit the research subject will undergo one of the three dietary lipid challenge tests (a shake) in a randomized order. On each study day research subjects will be asked to clock in 30 minutes prior to the first data collection points and a catheter cannula will be inserted in a antecubital vein. After the 30 minute rest, blood will be drawn from the catheter cannula and via a finger prick (baseline measurements, t0). After the baseline measurements, the research subjects will have to consume the shake within a time frame of 10 minutes. Blood is again drawn from the catheter cannula at t= 1, 2, 3, 4, 5, 6, 7, and 8 hours after consumption, with an additional finger prick at t=6. A questionnaire on hunger and satiety feelings will be taken after every blood draw.
Study population: The base population will consist of 40 healthy men and women with a BMI ranging from 22 to 27 kg/m2, aged 40 to 70 years old, selected from the surroundings of Wageningen through the mailing list for potential study research subjects of the division of Human Nutrition and health of Wageningen University. If needed, additional recruitment of research subjects will take place by flyers and posters, or advertisements in local newspapers.
Intervention: The dietary lipid challenge tests will be provided in the form of a liquid shake (0.6 L). Each shake will contain 95 gram of fat. The three types of fat that will be tested include: a) 100% vegetable fat blend, b) 100% Anhydrous milk fat (AMF), c) 100% cream (AMF + milk fat globular membranes).
- Conditions
- Genomics, Postprandial Metabolism, Nutrition, Metabolism
- Being tested
- 100% vegetable blend, 100% AMF, 100% cream
- Keywords
- Humans, Milk fat, Clinical Trial, Genomics, Metabolism, Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% vegetable blendOther
Dietary lipid challenge test: 600 ml skimmed milk plus 95 gram of vegetable fat blend.
100% AMFOther
Dietary lipid challenge test: 600 ml skimmed milk plus 95 gram of anhydrous milk fat.
100% creamOther
Dietary lipid challenge test: 600 ml skimmed milk plus 95 gram of anhydrous milk fat plus milk fat globular membranes.
| Study group | Role | What they receive |
|---|---|---|
| V-A-C | Experimental | Order of administration:
1. 100% vegetable fat blend
2. 100% Anhydrous Milk Fat (AMF)
3. 100% Cream (AMF + milk fat globular membranes) Receives: Other: 100% vegetable blend; Other: 100% AMF; Other: 100% cream |
| V-C-A | Experimental | Order of administration:
1. 100% vegetable fat blend
2. 100% Cream (AMF + milk fat globular membranes)
3. 100% Anhydrous Milk Fat (AMF) Receives: Other: 100% vegetable blend; Other: 100% AMF; Other: 100% cream |
| A-V-C | Experimental | Order of administration:
1. 100% Anhydrous Milk Fat (AMF)
2. 100% vegetable fat blend
3. 100% Cream (AMF + milk fat globular membranes) Receives: Other: 100% vegetable blend; Other: 100% AMF; Other: 100% cream |
| A-C-V | Experimental | Order of administration:
1. 100% Anhydrous Milk Fat (AMF)
2. 100% Cream (AMF + milk fat globular membranes)
3. 100% vegetable fat blend Receives: Other: 100% vegetable blend; Other: 100% AMF; Other: 100% cream |
| C-A-V | Experimental | Order of administration:
1. 100% Cream (AMF + milk fat globular membranes)
2. 100% Anhydrous Milk Fat (AMF)
3. 100% vegetable fat blend Receives: Other: 100% vegetable blend; Other: 100% AMF; Other: 100% cream |
| C-V-A | Experimental | Order of administration:
1. 100% Cream (AMF + milk fat globular membranes)
2. 100% vegetable fat blend
3. 100% Anhydrous Milk Fat (AMF) Receives: Other: 100% vegetable blend; Other: 100% AMF; Other: 100% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in transcriptomics from baseline to 6 hours after consumption of the three different fat blends, to elucidate underlying mechanistic responses in the circulation.
By using untargeted whole genome Affymetrix microarray the investigators will measure gene expression in isolated monocytes.
Measured: Baseline and 6 hours after consumption of the dietary lipid challenge.
Change in cytokine concentration from baseline and every hour until 8 hours after consumption of the different fat blends, to elucidate the effect on immune responses in the circulation.
Cytokine concentrations in the circulation will be measured via ELISA.
Measured: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Change in functional responses to LPS stimulation of isolated monocytes from the circulation from baseline to 6 hours after consumption of the different fat blends.
Cell study with isolated monocytes from the circulation. The cells will be treated with LPS to evaluate functional responses. We will measure fold changes.
Measured: Baseline and 6 hours after consumption of the dietary lipid challenge.
Change in sensitivity of isolated monocytes from the circulation.
Cell study with isolated monocytes from the circulation. The cells will be treated with different fat loads and inflammatory stimuli to evaluate the sensitivity of the collected monocytes. We will measure fold changes.
Measured: Baseline and 6 hours after consumption of the dietary lipid challenge.
Secondary outcomes (10)
Postprandial triacylglycerol changes
TAG concentration in plasma will be measured in a clinical chemical lab.
Measured: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Postprandial glucose changes
Cardio-metabolic markers such as glucose (mg/dl) will be measured in the circulation.
Measured: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Postprandial adiponectin changes
Cardio-metabolic markers such as adiponectin (pg/ml) will be measured in the circulation.
Measured: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Postprandial insulin changes
Cardio-metabolic markers such as insulin (mIU/L) will be measured in the circulation.
Measured: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Postprandial (untargeted) protein profile changes
Using untargeted proteomic platforms, the changes in protein profiles in the circulation will be measured.
Measured: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Postprandial (targeted) protein profile changes
Using targeted proteomic platforms, the changes in protein profiles in the circulation will be measured.
Measured: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Postprandial (untargeted) metabolite profile changes
Using untargeted metabolomic platforms, the changes in protein profiles in the circulation will be measured.
Measured: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Postprandial (targeted) metabolite profile changes
Using targeted metabolomic platforms, the changes in protein profiles in the circulation will be measured.
Measured: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Postprandial changes in feelings of hunger and satiety
Feelings of hunger and satiety will be measured via a questionnaire using a Visual Analog Scale (VAS), a 100 mm line anchored at each end by descriptors. Research subjects will place a mark on the scale that corresponds to their feelings of hunger and satiety. The distance from the lower end of the scale is then measured and recorded.
Measured: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Cytokine concentration comparison
Cytokine concentrations in the circulation obtained via catheter cannula will be measured via ELISA. The investigators will also measure cytokine concentrations in dried blood spots obtained via a finger prick (via a Meso Scale Discovery Electrochemiluminescence platform).
Measured: Baseline and 6 hours after consumption of the dietary lipid challenge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start2 Dec 2019 (estimated)
- Primary completion28 Feb 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GenomicsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each research subject will visit the university on three separate occasions with a wash-out period of at least one week. At each visit the research subject will undergo one of the three dietary lipid challenge tests (a shake) in a randomized order. All research subjects have consumed all three dietary lipid challenge tests at the end of the study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- FrieslandCampina N.V.
- Responsible party
- Principal investigator, Lydia A. Afman, Wageningen University
- Investigators
- Lydia Afman, PhD, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178681
- Sponsor's protocol ID
- NL69492.081.19
- Acronym
- POEMI
- Status last verified
- Nov 2019
- First submitted
- 16 Aug 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Collected data will be coded.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Fat Structures on Postprandial Responses in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04178681
- Acronym / sponsor ID
- POEMI / NL69492.081.19
- Conditions
- Genomics, Postprandial Metabolism, Nutrition, Metabolism
- Keywords
- Humans, Milk fat, Clinical Trial, Genomics, Metabolism, Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- FrieslandCampina N.V.
- Study start
- 2 Dec 2019 (estimated)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 26 Nov 2019 (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.
Nowadays, mostly vegetable fat blends are used in infant formula, but the use of bovine milk fat is increasing. In terms of fat structure, bovine milk fat and vegetable fats differ. Bovine milk fat has a higher percentage of palmitic acid attached to the sn-2 position of the glycerol backbone compared to vegetable fat blend. Also bovine milk fat contains milk fat globular membranes, as opposed to vegetable fat. With this study the investigators want to examine the effects of a vegetable fat blend versus bovine milk fat without globular membranes and bovine milk fat with globular membranes on underlying mechanistic, immune and metabolic responses.
Detailed description
Rationale: Human milk is considered as the ideal food for full-term infants. The composition and function of human milk is unique and has provided the basis for the development of modern artificial milk formulas that mimic its complex biological positive effects on infants and can provide an appropriate substitute for non-breastfed infants. An important component in human milk are the lipids, as they deliver 50% of the total energy to infants. Nowadays, mostly vegetable fat blends are used in infant formula, but the use of bovine milk fat is increasing. In terms of fat structure, bovine milk fat and vegetable fats differ. Bovine milk fat has a higher percentage of palmitic acid attached to the sn-2 position of the glycerol backbone compared to vegetable fat blend. Also bovine milk fat contains milk fat globular membranes, as opposed to vegetable fat. Knowledge on how these differences influence underlying mechanistic, immune and metabolic responses is lacking.
Objectives: The primary objective of this study is to determine the effect of three different fat blends on underlying mechanistic and immune responses in the circulation. The secondary objectives of this study are: 1) to examine the effects of the three different fat blends on postprandial triglyceride concentration and other cardio-metabolic markers in the circulation, 2) to investigate the effect of the three different fat blends on postprandial feelings of hunger and satiety, and 3) to investigate how comparable cytokine measurements are in blood samples obtained via a catheter cannula compared to cytokine measurements in dried blood spots obtained via a finger prick.
Study design: The POEMI Study is a double-blind randomized cross-over acute intervention study in which each research subject will visit the university on three separate occasions with a wash-out period of at least one week. At each visit the research subject will undergo one of the three dietary lipid challenge tests (a shake) in a randomized order. On each study day research subjects will be asked to clock in 30 minutes prior to the first data collection points and a catheter cannula will be inserted in a antecubital vein. After the 30 minute rest, blood will be drawn from the catheter cannula and via a finger prick (baseline measurements, t0). After the baseline measurements, the research subjects will have to consume the shake within a time frame of 10 minutes. Blood is again drawn from the catheter cannula at t= 1, 2, 3, 4, 5, 6, 7, and 8 hours after consumption, with an additional finger prick at t=6. A questionnaire on hunger and satiety feelings will be taken after every blood draw.
Study population: The base population will consist of 40 healthy men and women with a BMI ranging from 22 to 27 kg/m2, aged 40 to 70 years old, selected from the surroundings of Wageningen through the mailing list for potential study research subjects of the division of Human Nutrition and health of Wageningen University. If needed, additional recruitment of research subjects will take place by flyers and posters, or advertisements in local newspapers.
Intervention: The dietary lipid challenge tests will be provided in the form of a liquid shake (0.6 L). Each shake will contain 95 gram of fat. The three types of fat that will be tested include: a) 100% vegetable fat blend, b) 100% Anhydrous milk fat (AMF), c) 100% cream (AMF + milk fat globular membranes).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Each research subject will visit the university on three separate occasions with a wash-out period of at least one week. At each visit the research subject will undergo one of the three dietary lipid challenge tests (a shake) in a randomized order. All research subjects have consumed all three dietary lipid challenge tests at the end of the study.
| Arm | Type | Receives |
|---|---|---|
| V-A-C | Experimental | Other: 100% vegetable blend, Other: 100% AMF, Other: 100% creamOrder of administration: 1. 100% vegetable fat blend 2. 100% Anhydrous Milk Fat (AMF) 3. 100% Cream (AMF + milk fat globular membranes) |
| V-C-A | Experimental | Other: 100% vegetable blend, Other: 100% AMF, Other: 100% creamOrder of administration: 1. 100% vegetable fat blend 2. 100% Cream (AMF + milk fat globular membranes) 3. 100% Anhydrous Milk Fat (AMF) |
| A-V-C | Experimental | Other: 100% vegetable blend, Other: 100% AMF, Other: 100% creamOrder of administration: 1. 100% Anhydrous Milk Fat (AMF) 2. 100% vegetable fat blend 3. 100% Cream (AMF + milk fat globular membranes) |
| A-C-V | Experimental | Other: 100% vegetable blend, Other: 100% AMF, Other: 100% creamOrder of administration: 1. 100% Anhydrous Milk Fat (AMF) 2. 100% Cream (AMF + milk fat globular membranes) 3. 100% vegetable fat blend |
| C-A-V | Experimental | Other: 100% vegetable blend, Other: 100% AMF, Other: 100% creamOrder of administration: 1. 100% Cream (AMF + milk fat globular membranes) 2. 100% Anhydrous Milk Fat (AMF) 3. 100% vegetable fat blend |
| C-V-A | Experimental | Other: 100% vegetable blend, Other: 100% AMF, Other: 100% creamOrder of administration: 1. 100% Cream (AMF + milk fat globular membranes) 2. 100% vegetable fat blend 3. 100% Anhydrous Milk Fat (AMF) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Apparently healthy man or woman
- Age 40-70y at the time of recruitment
- BMI of 22-27 kg/m2
- Having a Hb value above 8.4 (men) or 7.4 (women) mmol/L (will be checked at the screening visit)
- Having veins suitable for blood sampling via a catheter cannula (judged by study nurse/ medical doctor)
Key exclusion criteria (16 listed)
- Any chronic metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease)
- History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
- Renal or hepatic malfunctioning (pre-diagnosis or determined based on ALAT, ASAT and creatinine values)
- Use of medication that may influence the study results, such as laxatives, stomach protectors and drugs that can affect intestinal motility.
- Donated or intend to donate blood from 2 months before the study until the end of the study
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 |
|---|---|---|
| 100% vegetable blendDietary lipid challenge test: 600 ml skimmed milk plus 95 gram of vegetable fat blend. | Other | A-C-V, A-V-C, C-A-V, C-V-A, V-A-C, V-C-A |
| 100% AMFDietary lipid challenge test: 600 ml skimmed milk plus 95 gram of anhydrous milk fat. | Other | A-C-V, A-V-C, C-A-V, C-V-A, V-A-C, V-C-A |
| 100% creamDietary lipid challenge test: 600 ml skimmed milk plus 95 gram of anhydrous milk fat plus milk fat globular membranes. | Other | A-C-V, A-V-C, C-A-V, C-V-A, V-A-C, V-C-A |
Primary outcome
Change in transcriptomics from baseline to 6 hours after consumption of the three different fat blends, to elucidate underlying mechanistic responses in the circulation.
Time frame: Baseline and 6 hours after consumption of the dietary lipid challenge.
By using untargeted whole genome Affymetrix microarray the investigators will measure gene expression in isolated monocytes.
Change in cytokine concentration from baseline and every hour until 8 hours after consumption of the different fat blends, to elucidate the effect on immune responses in the circulation.
Time frame: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Cytokine concentrations in the circulation will be measured via ELISA.
Change in functional responses to LPS stimulation of isolated monocytes from the circulation from baseline to 6 hours after consumption of the different fat blends.
Time frame: Baseline and 6 hours after consumption of the dietary lipid challenge.
Cell study with isolated monocytes from the circulation. The cells will be treated with LPS to evaluate functional responses. We will measure fold changes.
Change in sensitivity of isolated monocytes from the circulation.
Time frame: Baseline and 6 hours after consumption of the dietary lipid challenge.
Cell study with isolated monocytes from the circulation. The cells will be treated with different fat loads and inflammatory stimuli to evaluate the sensitivity of the collected monocytes. We will measure fold changes.
10 secondary outcomes
Postprandial triacylglycerol changes
Time frame: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Postprandial glucose changes
Time frame: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Postprandial adiponectin changes
Time frame: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Postprandial insulin changes
Time frame: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Postprandial (untargeted) protein profile changes
Time frame: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Postprandial (targeted) protein profile changes
Time frame: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Postprandial (untargeted) metabolite profile changes
Time frame: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Postprandial (targeted) metabolite profile changes
Time frame: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Postprandial changes in feelings of hunger and satiety
Time frame: Baseline and every hour until 8 hours after consumption of the dietary lipid challenge.
Cytokine concentration comparison
Time frame: Baseline and 6 hours after consumption of the dietary lipid challenge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: Undecided. Collected data will be coded.
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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.
Lydia Afman, PhD principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100% vegetable blend, 100% AMF and 100% cream in people with Genomics and Postprandial Metabolism, run by Wageningen University 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 7 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 26 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Michielsen, MSc (+31 317 484 864, charlotte.michielsen@wur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in transcriptomics from baseline to 6 hours after consumption of the three different fat blends, to elucidate underlying mechanistic responses in the circulation. (time frame: Baseline and 6 hours after consumption of the dietary lipid challenge.). The study lists 4 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 26 Nov 2019.