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ID
Source
Brief title
Health condition
digestive physiology
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: Gastric emptying half-time measured by MRI.
Secondary outcome
Secondary: Protein hydrolyses will be quantified by MRI T1 and T2 during digestion.
Background summary
Rationale: Gastric digestion is crucial to food structure breakdown, and subsequent digestion and nutrient absorption. Several studies have shown that protein-rich structured food (i.e. whey protein gel) with higher hardness digests slower during in vitro gastric digestion. However, no in vivo human data are available. In addition, a recent in vitro study showed that the hydrolysis of protein could be monitored by transverse relaxation time (T2), however the feasibility of MRI parameters (T1 and T2) still needs to be investigated in vivo.
Objective:
Primary: To investigate the effect of protein density and texture on gastric emptying of protein-rich solid food.
Secondary: To investigate the use of MRI T2 and T1 of gastric content on indicating protein hydrolysis in stomach.
Study design: Three treatments will be compared in a randomized crossover design.
Study population: 20 healthy adult males
Intervention (if applicable): Participants consume three types of whey protein gels (200 g): 1) low protein density + low hardness, 2) low protein density + high hardness, 3) high protein density + high hardness. MRI abdominal scans, and appetite and wellbeing ratings will be obtained before ingestion and every 10 min until 90 min after ingestion. After the MRI session, satiety will be measured by an ad libitum meal. MRI scans will be used to calculate gastric emptying half-time and MRI T1 and T2 will be used to quantify hydrolysis of protein.
Main study parameters/endpoints:
Primary: Gastric emptying half-time (GE-t50) measured by MRI.
Secondary: Protein hydrolyses will be quantified by MRI T1 and T2 during digestion.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The risks associated with participation are negligible. MRI is a safe and commonly used medical imaging modality. The stimuli consist of normally consumed food ingredients. The burden associated with participation consists of three 2 hours visits, which require an overnight fast and lying in the MRI scanner for 80 min (90 min - consumption time). This may cause minor discomfort. The study is non-therapeutic to the participants.
Study objective
The higher hardness/protein density of protein gel would delay gastric emptying and protein hydrolysis in humans; MRI technique can used to monitor gastric digestion (in this case: protein hydrolysis) in humans.
Study design
Every 10 minutes up to 90 min after ingestion
Intervention
Participants consume three types of whey protein gels (200 g): 1) low protein density + low hardness, 2) low protein density + high hardness, 3) high protein density + high hardness. MRI abdominal scans, and appetite and wellbeing ratings will be obtained before ingestion and every 10 min until 90 min after ingestion. After the MRI session, satiety will be measured by an ad libitum meal. MRI scans will be used to calculate gastric emptying half-time and MRI T1 and T2 will be used to quantify hydrolysis of protein.
Inclusion criteria
• 18-45 years old
• Male
• Apparently healthy (self-reported)
• Healthy body weight, BMI 18.5 - 25 kg/m2
• Able to speak and understand English without difficulty
Exclusion criteria
• Vegan
• Whey protein allergy or intolerance (self-reported)
• Food sensitivities towards any of the ingredients
• Gastric disorders or regular gastric complaints, such as heart burn
• Use of proton pump inhibitors or other medication which alters the normal functioning of the stomach
• Having a contra-indication to MRI scanning (including, but not limited to):
Pacemakers and defibrillators
Intraorbital or intraocular metallic fragments
Ferromagnetic implants
Claustrofobia
• Participating in any other medical-scientific research
• An employ from Human Nutrition and Health (WUR)
• A student or intern from Chair of Sensory Science and Eating Behaviour (WUR)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL8822 |
CCMO | NL74166.081.20 |
OMON | NL-OMON49394 |