An interventional study of Infant Formula in Infant Formula, sponsored by Wageningen University. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-01.
Sponsored by Wageningen University · Not applicable, Interventional, and Basic science
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.
Wageningen University is the lead sponsor of 153 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Gastric disorders or regular gastric complaints, for example heart burn
Having a contra-indication to MRI scanning, including, but not limited to:
Other: Infant Formula
Other: Infant Formula
Two infant formulas differing in composition
Gastric layer formation over time (mL) measured with MRI
Time frame: 2 hours
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
Verbal ratings of hunger, fullness, bloating and nausea.
Rated on a scale of 0-100, indicating 'not at all' to 'very much' respectively.
Time frame: 2 hours
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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