NCT04648397

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

November 16, 2020

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

11 days

First QC Date

November 5, 2020

Last Update Submit

January 18, 2021

Conditions

Glucose, High BloodGlucose, Low Blood

Keywords

Chewing behaviour

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • Amylase activity

    at day 1

  • 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

Study Arms (2)

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.

Other: Low glycaemic load, high fibrous productOther: High glycaemic load, low fibrous product

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.

Other: Low glycaemic load, high fibrous productOther: High glycaemic load, low fibrous product

Interventions

Low glycaemic load, high fibrous productOTHER

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

Long chewingShort chewing
High glycaemic load, low fibrous productOTHER

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.

Long chewingShort chewing

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

Location

Related Publications (1)

  • Chen Y, Stieger M, Capuano E, Forde CG, van der Haar S, Ummels M, van den Bosch H, de Wijk R. Influence of oral processing behaviour and bolus properties of brown rice and chickpeas on in vitro starch digestion and postprandial glycaemic response. Eur J Nutr. 2022 Dec;61(8):3961-3974. doi: 10.1007/s00394-022-02935-7. Epub 2022 Jun 30.

    PMID: 35773354DERIVED

Study Officials

  • Diederik Esser, PhD

    Wageningen University and Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 5, 2020

First Posted

December 1, 2020

Study Start

November 16, 2020

Primary Completion

November 27, 2020

Study Completion

November 27, 2020

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)