Gastric DigestionMOVENCT05854407
MRI Exploration of Protein Digestion
A study testing skim milk in people with Gastric Digestion, run by Wageningen University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Digestion
- What is being tested?
- skim milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 May 2023to 8 Sep 2023
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45y
- Apparently healthy
- Normal weight (BMI 18.5-25)
Who cannot join
- 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)
Show all 17Show fewer
- 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)
- Unwillingness to be referred to their general practitioner in case of chance findings of pathology
- Being an employee or student of the Division of Human Nutrition and Health or the Laboratory of Biophysics at Wageningen University.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Human Research Unit - Division of Human Nutrition and Health
Wageningen, 6708 WE
About this study
Official title: MRI Exploration of Protein Digestion - a Feasibility Study
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:
- Is there a significant effect of time on the postprandial magnetization transfer ratio (MTR) of the stomach contents?
- Can a difference in postprandial MTR of the stomach contents between the test products be detected?
Participants will visit after an overnight fast two times and then have MRI scans of the stomach before and after the consumption of 500 mL of pasteurized or high-pasteurized skim milk.
Read the detailed description
Rationale: Gastric digestion is the first step in the breakdown of dietary proteins, and is therefore essential for the further breakdown in the intestines and subsequent absorption of amino acids. Food processing, such as heating can modify the structure and digestibility of proteins. Digestion of dietary protein, and how this is affected by heating is often studied using in vitro digestion models that mimic the digestive tract. However, outcomes from these models need to be verified using in vivo digestion data from humans. Such data can in turn be used to improve digestion models. Magnetic resonance imaging (MRI) may be used to non-invasively monitor both in vitro and in vivo protein digestion, and hence, may bridge the gap between in vitro digestion models and real-life digestion physiology. The investigators have recently established candidate MRI markers for gastric protein digestion using in vitro models (MT and CEST MRI). As a next step, their potential for in vivo application needs to be established. Therefore, the aim of this research is to do a feasibility study in humans.
Objective: Assess the feasibility of using MT MRI for in vivo monitoring of gastric milk digestion (protein coagulation and breakdown).
Study design: Randomized cross-over study with two treatments.
Study population: 12 healthy volunteers, 18-45 years old.
Intervention: Participants will ingest 300 mL of commercial pasteurized skim milk (SM, heated for 20 s at 72 °C) and of high pasteurized skim milk (heated for 30 min at 80 °C). MRI scans of the stomach will be made at baseline, at t = 5 min and at 15-minute intervals up until t = 95 minutes after the start of ingestion. In addition, verbal ratings of hunger, fullness and nausea will be collected.
- Conditions
- Gastric Digestion
- Being tested
- skim milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skim milkOther
pasteurized or high-pasteurized skim milk
| Study group | Role | What they receive |
|---|---|---|
| pasteurized skim milk | Other | 300 mL of commercial pasteurized skim milk (heated for 15s at ~72 °C) Receives: 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 Receives: Other: skim milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
MT MRI scans of the stomach
average MTR of the stomach content over time
Measured: Baseline, T = 5, 20, 35, 50, 65, 80, 95 minutes after start of consumption
Secondary outcomes (1)
CEST MRI of the stomach
Average CESTR of the stomach content over time (measure of soluble proteins and peptides)
Measured: Baseline, T = 5, 20, 35, 50, 65, 80, 95 minutes after start of consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start9 May 2023
- Primary completion8 Sep 2023
- Study completion8 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric DigestionStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Smeets, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854407
- Sponsor's protocol ID
- NL83133.091.23
- Acronym
- MOVE
- Status last verified
- Dec 2023
- First submitted
- 19 Apr 2023
- Last updated
- 5 Dec 2023
- 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 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Exploration of Protein Digestion - a Feasibility Study
- ClinicalTrials.gov ID
- NCT05854407
- Acronym / sponsor ID
- MOVE / NL83133.091.23
- Conditions
- Gastric Digestion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 8 Sep 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 11 May 2023 (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.
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:
- Is there a significant effect of time on the postprandial magnetization transfer ratio (MTR) of the stomach contents?
- Can a difference in postprandial MTR of the stomach contents between the test products be detected?
Participants will visit after an overnight fast two times and then have MRI scans of the stomach before and after the consumption of 500 mL of pasteurized or high-pasteurized skim milk.
Detailed description
Rationale: Gastric digestion is the first step in the breakdown of dietary proteins, and is therefore essential for the further breakdown in the intestines and subsequent absorption of amino acids. Food processing, such as heating can modify the structure and digestibility of proteins. Digestion of dietary protein, and how this is affected by heating is often studied using in vitro digestion models that mimic the digestive tract. However, outcomes from these models need to be verified using in vivo digestion data from humans. Such data can in turn be used to improve digestion models. Magnetic resonance imaging (MRI) may be used to non-invasively monitor both in vitro and in vivo protein digestion, and hence, may bridge the gap between in vitro digestion models and real-life digestion physiology. The investigators have recently established candidate MRI markers for gastric protein digestion using in vitro models (MT and CEST MRI). As a next step, their potential for in vivo application needs to be established. Therefore, the aim of this research is to do a feasibility study in humans.
Objective: Assess the feasibility of using MT MRI for in vivo monitoring of gastric milk digestion (protein coagulation and breakdown).
Study design: Randomized cross-over study with two treatments.
Study population: 12 healthy volunteers, 18-45 years old.
Intervention: Participants will ingest 300 mL of commercial pasteurized skim milk (SM, heated for 20 s at 72 °C) and of high pasteurized skim milk (heated for 30 min at 80 °C). MRI scans of the stomach will be made at baseline, at t = 5 min and at 15-minute intervals up until t = 95 minutes after the start of ingestion. In addition, verbal ratings of hunger, fullness and nausea will be collected.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pasteurized skim milk | Other | Other: skim milk300 mL of commercial pasteurized skim milk (heated for 15s at ~72 °C) |
| High-pasteurized skim milk | Other | Other: skim milk300 mL of High-pasteurized skim milk prepared by heating commercial pasteurized skim milk for 30 min at 80 °C |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-45y
- Apparently healthy
- Normal weight (BMI 18.5-25)
Key exclusion criteria (17 listed)
- 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:
- Use of recreational drugs within one week before the test day (marihuana, XTC, GHB, helium)
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 |
|---|---|---|
| skim milkpasteurized or high-pasteurized skim milk | Other | High-pasteurized skim milk, pasteurized skim milk |
Primary outcome
MT MRI scans of the stomach
Time frame: Baseline, T = 5, 20, 35, 50, 65, 80, 95 minutes after start of consumption
average MTR of the stomach content over time
1 secondary outcome
CEST MRI of the stomach
Time frame: Baseline, T = 5, 20, 35, 50, 65, 80, 95 minutes after start of consumption
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 5 Dec 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skim milk in people with Gastric Digestion, 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 3 inclusion and 17 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 5 Dec 2023. 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?
MT MRI scans of the stomach (time frame: Baseline, T = 5, 20, 35, 50, 65, 80, 95 minutes after start of consumption). 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 5 Dec 2023.