The Effect of Chewing Duration on Blood Glucose Levels

Glucose, High Blood Clinical Trial

Official title:

The Effect of Chewing Duration on Blood Glucose Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648397
• Other study ID #: NL74340.081.20
• Status: Completed
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: November 27, 2020

Study information

• Verified date: January 2021
• Source: Wageningen University and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 27, 2020
• Est. primary completion date: November 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose, High Blood
• Glucose, Low Blood
• Hyperglycemia
• Hypoglycemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Stichting Wageningen Research	Wageningen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University and Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose responses in the 3 hrs following lunch	measured by a continuous glucose monitoring device	12 days in total to cover all test days
Secondary	Particle size of food bolus	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
Secondary	Amylase activity	measured in saliva	at day 1
Secondary	In vitro starch digestion rates in food bolus	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