MRI Exploration of Protein Digestion

NCT05854407 | Completed

• 1 other identifier: NL83133.091.23
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess the feasibility of using MRI for in vivo monitoring of gastric milk digestion (protein coagulation and breakdown). The study will be in healthy normal-weight individuals aged between 18 and 45 years. The main questions it aims to answer are:

1. 1.Is there a significant effect of time on the postprandial magnetization transfer ratio (MTR) of the stomach contents?
2. 2.Can a difference in postprandial MTR of the stomach contents between the test products be detected?

Conditions

Gastric Digestion

Outcome Measures

Primary Outcomes (1)

• MT MRI scans of the stomach

  average MTR of the stomach content over time

  Baseline, T = 5, 20, 35, 50, 65, 80, 95 minutes after start of consumption

Secondary Outcomes (1)

• CEST MRI of the stomach

  Baseline, T = 5, 20, 35, 50, 65, 80, 95 minutes after start of consumption

Other Outcomes (2)

• Verbal subjective ratings of appetite, thirst and wellbeing provided on a scale of 0 - 100 units

  Baseline, T = 5, 20, 35, 50, 65, 80, 95 minutes after start of consumption

• Gastric content volume

  Baseline, T = 5, 20, 35, 50, 65, 80, 95 minutes after start of consumption

Study Arms (2)

pasteurized skim milk

OTHER

300 mL of commercial pasteurized skim milk (heated for 15s at \~72 °C)

Other: skim milk

High-pasteurized skim milk

OTHER

300 mL of High-pasteurized skim milk prepared by heating commercial pasteurized skim milk for 30 min at 80 °C

Other: skim milk

Interventions

skim milk OTHER

pasteurized or high-pasteurized skim milk

High-pasteurized skim milk; pasteurized skim milk

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45y
• Apparently healthy
• Normal weight (BMI 18.5-25)

You may not qualify if:

• Milk protein allergy or intolerance (self-reported)
• Lactose intolerance (self-reported)
• Gastric disorders or regular (\>once a week) gastric complaints such as heartburn
• 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, and pH. For example, proton pump inhibitors, antacids, anti-depressants etc. (judged by our study doctor)
• Use of recreational drugs within one week before the test day (marihuana, XTC, GHB, helium)
• Being pregnant, lactating or planning on becoming pregnant during the study
• Alcohol consumption of more than 7 glasses per week
• Smoking (\>2 cigarettes a week)
• Having gained or lost more than 5 kg of weight in the last month.
• Participating in other biomedical research during the study period
• Having a contra-indication to MRI scanning:
• Intraorbital or intraocular metallic fragments
• Ferromagnetic implants
• Claustrophobia (self-reported)

Sponsors & Collaborators

• Wageningen University: lead

Study Sites (1)

Human Research Unit - Division of Human Nutrition and Health

Wageningen, 6708 WE, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (participant)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 11, 2023
• Study Start: May 9, 2023
• Primary Completion: September 8, 2023
• Study Completion: September 8, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)