- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04648397
The Effect of Chewing Duration on Blood Glucose Levels
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gelderland
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Wageningen, Gelderland, Netherlands, 6708 WG
- Stichting Wageningen Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Short chewing
Subjects consume two starch-based foods varying in fibre content e.g.
brown rice and chick-peas in duplicate following a short chewing protocol.
|
Test-lunch of 370 grams of chickpeas, seasoned with a herb- and spice mix to increase palatability.
Glycaemic load 18.5.
Consumed in duplicate.
Test-lunch of 257 grams of brown rice, seasoned with rice-oil and a herb- and spice mix to increase palatability.
Glycaemic load 44.9.
Consumed in duplicate.
|
Experimental: Long chewing
Subjects will consume two starch-based foods varying in fibre content e.g.
brown rice and chick-peas in duplicate following a long chewing protocol.
|
Test-lunch of 370 grams of chickpeas, seasoned with a herb- and spice mix to increase palatability.
Glycaemic load 18.5.
Consumed in duplicate.
Test-lunch of 257 grams of brown rice, seasoned with rice-oil and a herb- and spice mix to increase palatability.
Glycaemic load 44.9.
Consumed in duplicate.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood glucose responses in the 3 hrs following lunch
Time Frame: 12 days in total to cover all test days
|
measured by a continuous glucose monitoring device
|
12 days in total to cover all test days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Particle size of food bolus
Time Frame: 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
|
measured in food boli of the test-lunches by image analysis
|
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
|
Amylase activity
Time Frame: at day 1
|
measured in saliva
|
at day 1
|
In vitro starch digestion rates in food bolus
Time Frame: 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
|
assessed in food boli of the test-lunches by making use of INFOGEST 2.0 protocol
|
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
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NL74340.081.20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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