Infant FormulaGLAM-IINCT05224947
Gastric Layering and Monitoring II
A study testing Infant Formula in people with Infant Formula, run by Wageningen University at 1 site in Netherlands.
Trial summary
Rationale: Results from a previous study suggest that gastric layer formation, which is caused by emulsion instability as a result of gastric acidification/digestion, is different between breastmilk and infant formula. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infant Formula
- What is being tested?
- Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Jan 2022to 22 Apr 2022
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Apparently healthy (self-reported)
- Willing to be informed about incidental findings of pathology
- Willing to comply with the study procedures
Who cannot join
- Allergy or intolerance for cow milk, lactose, soy and/or fish (self-reported)
- Gastric disorders or regular gastric complaints, for example heart burn
- Use of medication which alters the normal functioning of the stomach, such as: Medical drug use that influences the GI tract's normal function, e.g. motility, pH etc.: among others use of protein pump inhibitors, antacids, anti-depressants etc. (judged by study doctor)
- Medical drug use that influences the GI tract's microbiota: antibiotic use within one month prior to the pre-study screening day (judged by study doctor)
- Smoking (>2 cigarettes a week)
- Drinking more than 14 glasses of alcohol a week
Show all 16Show fewer
- Having given a blood donation in the past two months
- Hb value below 8.4 mmol/L (as measured with finger-prick method at screening)
- Having a contra-indication to MRI scanning, including, but not limited to:
- Pacemakers and defibrillators
- Intraorbital or intraocular metallic fragments
- Ferromagnetic implants
- Claustrophobia
- Participating in other research during the study period
- Being an employee or student of the division of human nutrition and health
- Not having a general practitioner
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University & Research
Wageningen, Gelderland, 6708WE
About this study
Rationale: Results from a previous study suggest that gastric layer formation, which is caused by emulsion instability as a result of gastric acidification/digestion, is different between breastmilk and infant formula. The current study focusses on further understanding of these differences by investigating the effect of formula composition.
Objective: To investigate the effect of infant formula composition on intragastric behavior, gastric emptying and postprandial plasma parameters.
Read more
Study design: Double-blind cross-over study with two treatments.
Study population: 20 healthy normal-weight males, aged 18-45 y.
Intervention: After an overnight fast, participants will drink sufficient volume of one of the two IFs which differ in composition. Gastric content will be monitored using Magnetic Resonance Imaging (MRI). MRI scans will be done and blood samples will be taken for subsequent analyses at baseline and post prandially .
Main study parameters/endpoints: The primary outcome is gastric behavior. Secondary outcomes are total gastric content volume over time and blood parameters.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks associated with participation are low, as both phlebotomy and MRI are eminently safe medical techniques. In addition, the test formula are safe. Each participant will participate in 2 sessions, which require an overnight fast, 9 blood withdrawals (in total 120 mL per visit) and multiple MRI scans over a period of approximately 2 hours. These measurements are non-invasive and carry minimal risk. The burden of the sessions is most likely related to mild discomfort as they have to lie still in the MRI for two hours. This will be minimized by the soft mattress on the bed of the MRI, leg rest and a pillow underneath the head.
- Conditions
- Infant Formula
- Being tested
- Infant Formula
- Keywords
- Gastric behaviour, Nutrient absorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant FormulaOther
Two infant formulas differing in composition
| Study group | Role | What they receive |
|---|---|---|
| Infant formula A | Experimental | Not described Receives: Other: Infant Formula |
| Infant formula B | Experimental | Not described Receives: Other: Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric layer formation over time (mL) measured with MRI
Measured: 2 hours
Secondary outcomes (5)
Total gastric content volume over time (mL)
Measured: 2 hours
Concentration of glucose in blood over time
Measured: 2 hours
Concentration of insulin in blood over time
Measured: 2 hours
Concentration of free fatty acids in blood over time
Measured: 2 hours
Concentration of metabolites in blood over time measured with NMR (analysed by Nightingale: 'blood biomarker analysis service' )
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start28 Jan 2022
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant FormulaStudies 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
- Parallel groups
- Model description
- Randomized cross-over trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- FrieslandCampina
- Responsible party
- Principal investigator, Paul Smeets, Wageningen University
- Investigators
- Paul AM Smeets, PhD, Principal investigator, Wageningen University & Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224947
- Sponsor's protocol ID
- NL77717.091.21
- Acronym
- GLAM-II
- Status last verified
- Mar 2024
- First submitted
- 10 Dec 2021
- Last updated
- 1 Apr 2024
- 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 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Layering and Monitoring II
- ClinicalTrials.gov ID
- NCT05224947
- Acronym / sponsor ID
- GLAM-II / NL77717.091.21
- Conditions
- Infant Formula
- Keywords
- Gastric behaviour, Nutrient absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- FrieslandCampina
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 4 Feb 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.
Rationale: Results from a previous study suggest that gastric layer formation, which is caused by emulsion instability as a result of gastric acidification/digestion, is different between breastmilk and infant formula. The current study focusses on further understanding of these differences by investigating the effect of formula composition.
Objective: To investigate the effect of infant formula composition on intragastric behavior, gastric emptying and postprandial plasma parameters.
Study design: Double-blind cross-over study with two treatments.
Study population: 20 healthy normal-weight males, aged 18-45 y.
Intervention: After an overnight fast, participants will drink sufficient volume of one of the two IFs which differ in composition. Gastric content will be monitored using Magnetic Resonance Imaging (MRI). MRI scans will be done and blood samples will be taken for subsequent analyses at baseline and post prandially .
Main study parameters/endpoints: The primary outcome is gastric behavior. Secondary outcomes are total gastric content volume over time and blood parameters.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks associated with participation are low, as both phlebotomy and MRI are eminently safe medical techniques. In addition, the test formula are safe. Each participant will participate in 2 sessions, which require an overnight fast, 9 blood withdrawals (in total 120 mL per visit) and multiple MRI scans over a period of approximately 2 hours. These measurements are non-invasive and carry minimal risk. The burden of the sessions is most likely related to mild discomfort as they have to lie still in the MRI for two hours. This will be minimized by the soft mattress on the bed of the MRI, leg rest and a pillow underneath the head.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized cross-over trial
| Arm | Type | Receives |
|---|---|---|
| Infant formula A | Experimental | Other: Infant Formula |
| Infant formula B | Experimental | Other: Infant Formula |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- Apparently healthy (self-reported)
- Willing to be informed about incidental findings of pathology
- Willing to comply with the study procedures
Key exclusion criteria (16 listed)
- Allergy or intolerance for cow milk, lactose, soy and/or fish (self-reported)
- Gastric disorders or regular gastric complaints, for example heart burn
- Smoking (>2 cigarettes a week)
- Drinking more than 14 glasses of alcohol a week
- Having given a blood donation in the past two months
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 |
|---|---|---|
| Infant FormulaTwo infant formulas differing in composition | Other | Infant formula A, Infant formula B |
Primary outcome
Gastric layer formation over time (mL) measured with MRI
Time frame: 2 hours
5 secondary outcomes
Total gastric content volume over time (mL)
Time frame: 2 hours
Concentration of glucose in blood over time
Time frame: 2 hours
Concentration of insulin in blood over time
Time frame: 2 hours
Concentration of free fatty acids in blood over time
Time frame: 2 hours
Concentration of metabolites in blood over time measured with NMR (analysed by Nightingale: 'blood biomarker analysis service' )
Time frame: 2 hours
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 1 Apr 2024.
- 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.
Paul AM Smeets, 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?
A study testing Infant Formula in people with Infant Formula, 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 4 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: finished, as of the sponsor's last update on 1 Apr 2024. 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?
Gastric layer formation over time (mL) measured with MRI (time frame: 2 hours). 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 1 Apr 2024.