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Completed

NCT Number: NCT04648397

The Effect of Chewing Duration on Blood Glucose Levels

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.

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Key information

Conditions

Glucose, High Blood Glucose, Low Blood

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low glycaemic load, high fibrous product

Other

Test-lunch of 370 grams of chickpeas, seasoned with a herb- and spice mix to increase palatability. Glycaemic load 18.5. Consumed in duplicate.

High glycaemic load, low fibrous product

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Wageningen University and Research

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 1, 2020
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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