Gastric Layering and Monitoring II (GLAM-II)

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 Overview

• Status: Completed
• Conditions: Infant Formula
• Intervention / Treatment: Other: Infant Formula

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julia JM Roelofs, MSc.; Phone Number: 0031 0657378595; Email: julia.roelofs@wur.nl

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708WE
      • Wageningen University & Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male
• Apparently healthy (self-reported)
• Willing to be informed about incidental findings of pathology
• Willing to comply with the study procedures

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infant formula A	Other: Infant Formula; Two infant formulas differing in composition
Experimental: Infant formula B	Other: Infant Formula; Two infant formulas differing in composition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gastric layer formation over time (mL) measured with MRI	2 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Total gastric content volume over time (mL)	2 hours
Concentration of glucose in blood over time	2 hours
Concentration of insulin in blood over time	2 hours
Concentration of free fatty acids in blood over time	2 hours
Concentration of metabolites in blood over time measured with NMR (analysed by Nightingale: 'blood biomarker analysis service' )	2 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal ratings of hunger, fullness, bloating and nausea.	Rated on a scale of 0-100, indicating 'not at all' to 'very much' respectively.	2 hours

Collaborators and Investigators

• Sponsor: Wageningen University
• Collaborators: FrieslandCampina
• Investigators: Principal Investigator: Paul AM Smeets, PhD, Wageningen University & Research

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2022
• Primary Completion (Actual): April 22, 2022
• Study Completion (Actual): April 22, 2022

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Nutrient absorption; Gastric behaviour
• Other Study ID Numbers: NL77717.091.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No