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The Effect of Chewing Duration on Blood Glucose Levels

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ClinicalTrials.gov Identifier: NCT04648397
Recruitment Status : Completed
First Posted : December 1, 2020
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Diederik Esser, Wageningen University and Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glucose, High Blood Glucose, Low Blood Other: Low glycaemic load, high fibrous product Other: High glycaemic load, low fibrous product Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Chewing Duration on Blood Glucose Levels
Actual Study Start Date : November 16, 2020
Actual Primary Completion Date : November 27, 2020
Actual Study Completion Date : November 27, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arms and Interventions
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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.
 Other: Low glycaemic load, high fibrous product
Test-lunch of 370 grams of chickpeas, seasoned with a herb- and spice mix to increase palatability. Glycaemic load 18.5. Consumed in duplicate.

Other: High glycaemic load, low fibrous product
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.
 Other: Low glycaemic load, high fibrous product
Test-lunch of 370 grams of chickpeas, seasoned with a herb- and spice mix to increase palatability. Glycaemic load 18.5. Consumed in duplicate.

Other: High glycaemic load, low fibrous product
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Amylase activity [ Time Frame: at day 1 ]
    measured in saliva

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04648397


Locations
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Netherlands
Stichting Wageningen Research
Wageningen, Gelderland, Netherlands, 6708 WG
Sponsors and Collaborators
Wageningen University and Research
Investigators
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Principal Investigator: Diederik Esser, PhD Wageningen University and Research
More Information
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Responsible Party: Diederik Esser, Principal investigator, Wageningen University and Research
ClinicalTrials.gov Identifier: NCT04648397    
Other Study ID Numbers: NL74340.081.20
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Diederik Esser, Wageningen University and Research:
Chewing behaviour
Additional relevant MeSH terms:
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Hyperglycemia
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases