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Milk and Plant Protein Digestion

Postprandial Amino Acid Profiles and Gastric Protein Coagulation After Consumption of Milk and Plant-based Alternatives: an Exploratory Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06272331
Acronym
MAPP-D
Enrollment
12
Registered
2024-02-22
Start date
2024-02-06
Completion date
2024-07-24
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Digestion

Keywords

Plant-based drink, Milk, Postprandial plasma response, MRI

Brief 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. 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.

Interventions

OTHERLow-protein plant-based drink

Ingestion of a low-protein plant-based drink

OTHERHigh-protein plant-based drink

Ingestion of a high-protein plant-based drink

Ingestion of cow's milk

Sponsors

FrieslandCampina
CollaboratorINDUSTRY
Wageningen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Postprandial plasma amino acid profile as characterized by the peak height and iAUC5 hoursChange in postprandial plasma amino acid profile over time

Secondary

MeasureTime frameDescription
Gastric behavior2 hoursChange in gastric behavior over time as determined from an abdominal MRI scan
Postprandial plasma response5 hoursChange in postprandial plasma response from baseline over time

Other

MeasureTime frameDescription
Verbal ratings of wellbeing5 hoursChange in wellbeing from baseline over time on a 100-point scale
MRI markers of digestion2 hoursChange in Magnetization Transfer ratio from baseline over time

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026