The specific objective of this study is to compare gastrointestinal digestion (gastric content volume changes and postprandial amino acids dynamics) between pea-protein based foods with different heat treatments and viscosity. The overarching…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
eiwitvertering bij gezonde mensen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gastric content volume over time, postprandial plasma amino-acid
concentrations.
Secondary outcome
Intra-gastric processes (coagulation, emulsion stability), MRI markers (T2, MT)
Background summary
Due to global population growth and environmental constraints, the demand for
food proteins from sustainable sources is rapidly growing. The quickly
expanding field of plant-based food, generally uses protein concentrates or
isolates as protein source. It is not clear yet to what extent heat treatment
and structure affects their digestibility in vivo. Magnetic resonance imaging
(MRI) is a promising research tool to assess such protein food characteristics
in vivo.
Study objective
The specific objective of this study is to compare gastrointestinal digestion
(gastric content volume changes and postprandial amino acids dynamics) between
pea-protein based foods with different heat treatments and viscosity. The
overarching objective of this study is to demonstrate the utility of MRI as a
research tool for monitoring protein digestion.
Study design
Randomized, balanced cross-over study with three treatments.
Intervention
Participants will ingest three 400-mL test foods containing 20 g pea protein:
- Protein in suspension: 5% (5 g/100g) protein suspension unheated
- Protein in suspension: 5% (5 g/100g) protein suspension heated at 90°C
- Protein gel (representing the food matrix): 25% pea protein isolate gel,
prepared via heating at 90°C
Gastric content volume changes and appetite ratings will be measured at
baseline and every ten minutes postprandial up until 90 minutes. Baseline and
postprandial plasma amino-acid concentrations will be measured up to 5 hours
postprandial.
Study burden and risks
The risks associated with participation are low, as both phlebotomy and MRI are
eminently safe techniques, and the test foods consist of food grade
ingredients. The burden associated with participation consists of three visits
after an overnight fast, 10 blood draws (totalling 123 mL) and multiple MRI
scans over a period of 5 hours. These may all cause minimal discomfort. There
is no benefit of participation for the participants. The study must be
performed in healthy males.
Stippeneng 4
Wageningen 6708WE
NL
Stippeneng 4
Wageningen 6708WE
NL
Listed location countries
Age
Inclusion criteria
• Male
• 18 - 55 yr old
• In self-reported health
• BMI between 18,5 and 25kg/m2
Exclusion criteria
• Pea protein allergy (self-reported)
• Disorders of the upper ingestive tract resulting in difficulties
chewing/swallowing.
• Unexplained weight change >5 kg in the month within 1 month prior to the
pre-study screeningsday
• Gastric disorders or regular gastric complaints, heart burn for example
• Use of proton pump inhibitors or other medication which alters the normal
functioning of the stomach
• Use of a medical drug use that influences the GI tract*s normal function,
e.g. the motility, pH etc: among others use of proton pump inhibitors,
antacids, anti-depressants etc.
• Use of a medical drug use that influence the GI tract*s microbiota:
antibiotic use within 1 months prior to the pre-study screenings day
• use of recreational drugs within 1 month prior to the pre-study screenings day
• alcohol consumption of more than 14 glasses/week
• Smoking (>2 sigarettes a week)
• Having a contra-indication to MRI scanning (including, but not limited to):
* Pacemakers and defibrillators
* Intraorbital or intraocular metallic fragments
* Ferromagnetic implants
* Claustrofobic
• Not wanting information at unexpected findings
• Use of protein supplements during the study
• Following a medical diet
• Being an employee or student of the Division of Human Nutrition and health
•Having donated blood in the two months preceding the first visit
•Hb value below 8.4 mmol/L (as measured with finger-prick method)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74440.081.20 |
| Other | Zal parallel worden geregistreerd in Dutch Trial register |