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Clinical Trials/NCT04648397
NCT04648397CompletedNot Applicable

The Effect of Chewing Duration on Blood Glucose Levels

Wageningen University and Research1 site in 1 country26 target enrollmentStarted: November 16, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
1
Primary Endpoint
Blood glucose responses in the 3 hrs following lunch

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Short chewing

Experimental

Subjects consume two starch-based foods varying in fibre content e.g. brown rice and chick-peas in duplicate following a short chewing protocol.

Intervention: Low glycaemic load, high fibrous product (Other)

Short chewing

Experimental

Subjects consume two starch-based foods varying in fibre content e.g. brown rice and chick-peas in duplicate following a short chewing protocol.

Intervention: High glycaemic load, low fibrous product (Other)

Long chewing

Experimental

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.

Intervention: Low glycaemic load, high fibrous product (Other)

Long chewing

Experimental

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.

Intervention: High glycaemic load, low fibrous product (Other)

Outcomes

Primary Outcomes

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 Outcomes

  • In vitro starch digestion rates in food bolus(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(at day 1)
  • Particle size of food bolus(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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Diederik Esser

Principal investigator

Wageningen University and Research

Study Sites (1)

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