The Effect of Chewing Duration on Blood Glucose Levels

Sponsor
Wageningen University and Research (Other)
Overall Status
Completed
CT.gov ID
NCT04648397
Collaborator
(none)
26
1
2
11
71.9

Study Details

Study Description

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
  • Other: Low glycaemic load, high fibrous product
  • Other: High glycaemic load, low fibrous product
N/A

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
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 :
Nov 16, 2020
Actual Primary Completion Date :
Nov 27, 2020
Actual Study Completion Date :
Nov 27, 2020

Arms and Interventions

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

Primary Outcome Measures

  1. Blood glucose responses in the 3 hrs following lunch [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 [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 [at day 1]

    measured in saliva

  3. 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]

    assessed in food boli of the test-lunches by making use of INFOGEST 2.0 protocol

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stichting Wageningen Research Wageningen Gelderland Netherlands 6708 WG

Sponsors and Collaborators

  • Wageningen University and Research

Investigators

  • Principal Investigator: Diederik Esser, PhD, Wageningen University and Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Diederik Esser, Principal investigator, Wageningen University and Research
ClinicalTrials.gov Identifier:
NCT04648397
Other Study ID Numbers:
  • NL74340.081.20
First Posted:
Dec 1, 2020
Last Update Posted:
Jan 20, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Diederik Esser, Principal investigator, Wageningen University and Research

Study Results

No Results Posted as of Jan 20, 2021