Clinical trial NCT04648397: The Effect of Chewing Duration on Blood Glucose Levels
Official title: The Effect of Chewing Duration on Blood Glucose Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose, High Blood
Glucose, Low Blood
Keywords: Chewing behaviour
Lead sponsor: Wageningen University and Research
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study aims to assess the impact of speed of consumption of two starch-based foods varying in fibre content on blood glucose levels in normal healthy subjects. Furthermore, the mediating roles of salivary amylase and particle size on blood glucose levels will be studied. The study has a randomized cross-over design. Subjects consume two test-lunches (chick peas and brown rice) in duplicate on 8 different test days, at either long or short chewing duration. Glucose responses will be monitored via a continuous glucose monitoring device and expectorated boluses will be collected during each test day for assessments of amylase activity and food particle size.

Detailed description: Research suggests that high glucose level variability and large dips in glucose levels may have a negative impact on cognitive function and self-reported wellbeing. The way food is consumed (e.g. chewing duration) may regulate blood glucose levels. The underlying mechanism that links consumption speed to metabolic responses, satiation and health is largely unknown.

This study aims to assess the impact of speed of consumption of two starch-based foods varying in fibre content, on blood glucose levels in normal healthy subjects. Furthermore, the mediating roles of salivary amylase and particle size on blood glucose levels are studied.

The study has a randomized cross-over design. Each subject consumes two different test-lunches (chick peas and brown rice) in duplicate at either long or short duration. Their breakfast will be standardized during these 8 test days. For a duration of 12 days, blood glucose levels will be monitored via a continuous glucose device. Furthermore expectorated boluses will be collected for assessment of amylase activity and food particle size.

Eligibility criteria: Inclusion Criteria:

* Apparently healthy men and women (based on questionnaire, self-reported)
* Aged between 18 - 55 yrs
* BMI between 18.5 - 30 kg/m2
* In possession of a Smartphone running on iOS or Android

Exclusion Criteria:

* Diagnosed with Diabetes mellitus type 1 or 2
* Under treatment for neurological or psychiatric complaints, including eating disorders
* History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
* Use of medication/supplements that may influence the study results, such as medicines known to interfere with glucose homeostasis. This will be judged by our medical doctor
* Following a diet or gained/lost \>=5kg weight in the previous month.
* Coeliac disease or gluten intolerance
* Skin allergy, eczema or known sensitivity for plasters
* use of drugs
* Current smokers
* Using \> 14 glasses of alcohol per week
* Having a food allergy for the test foods
* Participation in another clinical trial at the same time
* Suffering from a stomach emptying disorder
* Employed by or an intern at the FHCR group of Wageningen Food \& Biobased Research.

Primary outcomes:
measure: Blood glucose responses in the 3 hrs following lunch
timeFrame: 12 days in total to cover all test days
Secondary outcomes:
measure: Particle size of food bolus
timeFrame: on 4 of the 8 test days, at day 1, day 2, day 3 and day 4 or day 5, day 6, day 7 and day 8 depending on group
measure: Amylase activity
timeFrame: at day 1
measure: In vitro starch digestion rates in food bolus
timeFrame: on 4 of the 8 test days, at day 1, day 2, day 3 and day 4 or day 5, day 6, day 7 and day 8 depending on group
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Stichting Wageningen Research
state: Gelderland
Study officials:
affiliation: Wageningen University and Research
name: Diederik Esser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen Y, Stieger M, Capuano E, Forde CG, van der Haar S, Ummels M, van den Bosch H, de Wijk R. Influence of oral processing behaviour and bolus properties of brown rice and chickpeas on in vitro starch digestion and postprandial glycaemic response. Eur J Nutr. 2022 Dec;61(8):3961-3974. doi: 10.1007/s00394-022-02935-7. Epub 2022 Jun 30.