Gastric layering and milk

SUMMARY



Rationale: In some cases, breastfeeding is replaced with infant formula. Infant formula should strive to mimic breastmilk as closely as possible. Gastric dynamics after ingestion are unknown for both infant formula and breastmilk, as well as their relative differences.

Objective: To compare gastric emptying and intragastric layering of breastmilk and infant formula.

Study design: Crossover study

Study population: 14 healthy lactating mothers.

Intervention: Each participant will drink 200 mL of her own breastmilk and, in another session, commercial infant formula. Gastric content will be monitored using magnetic resonance imaging (MRI). MRI scans will be done at baseline and at time points t = 0, 10, 20, 30, 40, 50, 60 minutes after ingestion. Participants are asked to come in fasted. The participants will be asked to rate their sense of fullness, bloating and nausea from 0 to a 100.



Main study parameters/endpoints: Gastric content in mL over time and mL of the individual layers within the stomach.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Each participant will partake in 2 sessions of approximately 1.5 hours each. The breastmilk (being their own) and infant formula are considered eminently safe. After and before consumption MRI scans are made to measure gastric content. These measurements are non-invasive and carry minimal risk. The burden of the sessions is anticipated to most likely be related to mild fatigue and/or boredom, which will be counteracted by allowing the participants to listen to the radio during the session. The study is non-therapeutic to the participants.

human milk will phase separate and thereby empty differently from infant formula

every 10 minutes 60 minutes post ingestion

human milk and infant formula (200mL)