Food DigestionMAPP-DNCT06272331
Milk and Plant Protein Digestion
A study testing Low-protein plant-based drink, High-protein plant-based drink and Cow's milk in people with Food Digestion, run by Wageningen University at 1 site in Netherlands.
Trial summary
The goal of this study is to explore the effect of protein quantity and quality in plant-based drinks. Healthy normal-weight males aged between 18 and 45 years will be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Food Digestion
- What is being tested?
- Low-protein plant-based drink, High-protein plant-based drink and Cow's milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Feb 2024to 24 Jul 2024
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Age 18 - 45 y
- Apparently healthy (self-reported)
- Normal-weight (BMI 18.5 - 25 kg/m2)
- Willing to be informed about incidental findings of pathology
- Willing to comply with the study procedures
Who cannot join
- Allergy or intolerance for cow milk, lactose or gluten (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)
- Following a vegan diet
Show all 18Show fewer
- Smoking (>2 cigarettes a week)
- Having a chronic illness that could affect food digestion and nutrient absorption including but not limited to kidney disease, thyroid disease and diabetes mellitus (self-reported)
- Alcohol consumption of more than 14 glasses/week
- Having given a blood donation in the past two months
- Hb value below 8.5 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
- Not having a general practitioner
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Human Research Unit - Division of Human Nutrition and Health
Wageningen, 6708WE
About this study
Official title: Postprandial Amino Acid Profiles and Gastric Protein Coagulation After Consumption of Milk and Plant-based Alternatives: an Exploratory Study
The goal of this study is to explore the effect of protein quantity and quality in plant-based drinks. Healthy normal-weight males aged between 18 and 45 years will be included in the study.
The main objectives are to examine the differences in postprandial amino acid profiles, and to examine differences in gastric behavior between cow's milk and plant based drinks.
Participants will visit after an overnight fast three times and have blood draws before and after consumption one of the study drinks. There will be MRI scans of the stomach before and after consumption of the drink to assess gastric behavior.
Read the detailed description
Rationale: There is a growing interest in plant-based alternatives for bovine milk. However, these plant-based drinks are not a complete nutritional substitute for bovine milk, especially when focusing on the protein content and quality of these products. Knowledge on the effects of protein quantity and quality of plant based drinks on postprandial plasma responses and gastric behavior compared to bovine milk is lacking.
Objective: To explore the effect of protein quantity and quality of protein in plant-based drinks. In addition, gastric behavior will be examined and compared to that of bovine milk.
Study design: Single-blind randomized cross-over study with three treatments.
Study population: 12 healthy normal-weight males, aged 18-45 y.
Intervention: After an overnight fast, participants will drink cow's milk, or a plant-based drink. Gastric behavior will be monitored using Magnetic Resonance Imaging (MRI). Blood samples will be collected for plasma metabolomic analyses. In addition, wellbeing will be assessed.
- Conditions
- Food Digestion
- Being tested
- Low-protein plant-based drink, High-protein plant-based drink, Cow's milk
- Keywords
- Plant-based drink, Milk, Postprandial plasma response, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-protein plant-based drinkOther
Ingestion of a low-protein plant-based drink
High-protein plant-based drinkOther
Ingestion of a high-protein plant-based drink
Cow's milkOther
Ingestion of cow's milk
| Study group | Role | What they receive |
|---|---|---|
| Low-protein plant-based drink | Other | Ingestion of a low-protein plant-based drink. Receives: Other: Low-protein plant-based drink |
| High-protein plant-based drink | Other | Ingestion of a high-protein plant-based drink Receives: Other: High-protein plant-based drink |
| Cow's milk | Other | Ingestion of cow's milk. Receives: Other: Cow's milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial plasma amino acid profile as characterized by the peak height and iAUC
Change in postprandial plasma amino acid profile over time
Measured: 5 hours
Secondary outcomes (2)
Gastric behavior
Change in gastric behavior over time as determined from an abdominal MRI scan
Measured: 2 hours
Postprandial plasma response
Change in postprandial plasma response from baseline over time
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start6 Feb 2024
- Primary completion24 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food 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
- Other
- 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
- Collaborators
- FrieslandCampina
- Responsible party
- Principal investigator, Paul Smeets, Wageningen University
- Investigators
- Paul Smeets, PhD, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272331
- Sponsor's protocol ID
- NL83162.091.22
- Acronym
- MAPP-D
- Status last verified
- Jul 2024
- First submitted
- 9 Feb 2024
- Last updated
- 29 Jul 2024
- 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 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Amino Acid Profiles and Gastric Protein Coagulation After Consumption of Milk and Plant-based Alternatives: an Exploratory Study
- ClinicalTrials.gov ID
- NCT06272331
- Acronym / sponsor ID
- MAPP-D / NL83162.091.22
- Conditions
- Food Digestion
- Keywords
- Plant-based drink, Milk, Postprandial plasma response, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- FrieslandCampina
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 22 Feb 2024 (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 explore the effect of protein quantity and quality in plant-based drinks. Healthy normal-weight males aged between 18 and 45 years will be included in the study.
The main objectives are to examine the differences in postprandial amino acid profiles, and to examine differences in gastric behavior between cow's milk and plant based drinks.
Participants will visit after an overnight fast three times and have blood draws before and after consumption one of the study drinks. There will be MRI scans of the stomach before and after consumption of the drink to assess gastric behavior.
Detailed description
Rationale: There is a growing interest in plant-based alternatives for bovine milk. However, these plant-based drinks are not a complete nutritional substitute for bovine milk, especially when focusing on the protein content and quality of these products. Knowledge on the effects of protein quantity and quality of plant based drinks on postprandial plasma responses and gastric behavior compared to bovine milk is lacking.
Objective: To explore the effect of protein quantity and quality of protein in plant-based drinks. In addition, gastric behavior will be examined and compared to that of bovine milk.
Study design: Single-blind randomized cross-over study with three treatments.
Study population: 12 healthy normal-weight males, aged 18-45 y.
Intervention: After an overnight fast, participants will drink cow's milk, or a plant-based drink. Gastric behavior will be monitored using Magnetic Resonance Imaging (MRI). Blood samples will be collected for plasma metabolomic analyses. In addition, wellbeing will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-protein plant-based drink | Other | Other: Low-protein plant-based drinkIngestion of a low-protein plant-based drink. |
| High-protein plant-based drink | Other | Other: High-protein plant-based drinkIngestion of a high-protein plant-based drink |
| Cow's milk | Other | Other: Cow's milkIngestion of cow's milk. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male
- Age 18 - 45 y
- Apparently healthy (self-reported)
- Normal-weight (BMI 18.5 - 25 kg/m2)
- Willing to be informed about incidental findings of pathology
Key exclusion criteria (18 listed)
- Allergy or intolerance for cow milk, lactose or gluten (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:
- Following a vegan diet
- Smoking (>2 cigarettes a week)
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 |
|---|---|---|
| Low-protein plant-based drinkIngestion of a low-protein plant-based drink | Other | Low-protein plant-based drink |
| High-protein plant-based drinkIngestion of a high-protein plant-based drink | Other | High-protein plant-based drink |
| Cow's milkIngestion of cow's milk | Other | Cow's milk |
Primary outcome
Postprandial plasma amino acid profile as characterized by the peak height and iAUC
Time frame: 5 hours
Change in postprandial plasma amino acid profile over time
2 secondary outcomes
Gastric behavior
Time frame: 2 hours
Postprandial plasma response
Time frame: 5 hours
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 29 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Food Digestion
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Recruiting
IBS Skin Patch Test Food Allergy Study
Irritable Bowel Syndrome
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
Recruiting
Fermented Foods and Bowel Health in SCI
Spinal Cord Injury
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.
Paul Smeets, PhD principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-protein plant-based drink, High-protein plant-based drink and Cow's milk in people with Food 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 6 inclusion and 18 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 29 Jul 2024. 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?
Postprandial plasma amino acid profile as characterized by the peak height and iAUC (time frame: 5 hours). 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 29 Jul 2024.