Glucose, High BloodNCT04648397
The Effect of Chewing Duration on Blood Glucose Levels
A study testing Low glycaemic load, high fibrous product and High glycaemic load, low fibrous product in people with Glucose, High Blood and Glucose, Low Blood, run by Wageningen University and Research at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose, High Blood, Glucose, Low Blood
- What is being tested?
- Low glycaemic load, high fibrous product and High glycaemic load, low fibrous product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Nov 2020to 27 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG
About this study
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.
Read the 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.
- Conditions
- Glucose, High Blood, Glucose, Low Blood
- Being tested
- Low glycaemic load, high fibrous product, High glycaemic load, low fibrous product
- Keywords
- Chewing behaviour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Low glycaemic load, high fibrous product; Other: 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. Receives: Other: Low glycaemic load, high fibrous product; Other: High glycaemic load, low fibrous product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose responses in the 3 hrs following lunch
measured by a continuous glucose monitoring device
Measured: 12 days in total to cover all test days
Secondary outcomes (3)
Particle size of food bolus
measured in food boli of the test-lunches by image analysis
Measured: 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
measured in saliva
Measured: at day 1
In vitro starch digestion rates in food bolus
assessed in food boli of the test-lunches by making use of INFOGEST 2.0 protocol
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start16 Nov 2020
- Primary completion27 Nov 2020
- Study completion27 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glucose, High BloodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diederik Esser, Wageningen University and Research
- Investigators
- Diederik Esser, PhD, Principal investigator, Wageningen University and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648397
- Sponsor's protocol ID
- NL74340.081.20
- Status last verified
- Jan 2021
- First submitted
- 5 Nov 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35773354
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chewing Duration on Blood Glucose Levels
- ClinicalTrials.gov ID
- NCT04648397
- Acronym / sponsor ID
- NL74340.081.20
- Conditions
- Glucose, High Blood, Glucose, Low Blood
- Keywords
- Chewing behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 27 Nov 2020 (actual)
- Study completion
- 27 Nov 2020 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short chewing | Experimental | Other: Low glycaemic load, high fibrous product, Other: High glycaemic load, low fibrous productSubjects consume two starch-based foods varying in fibre content e.g. brown rice and chick-peas in duplicate following a short chewing protocol. |
| Long chewing | Experimental | Other: Low glycaemic load, high fibrous product, Other: High glycaemic load, low fibrous productSubjects will consume two starch-based foods varying in fibre content e.g. brown rice and chick-peas in duplicate following a long chewing protocol. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low glycaemic load, high fibrous productTest-lunch of 370 grams of chickpeas, seasoned with a herb- and spice mix to increase palatability. Glycaemic load 18.5. Consumed in duplicate. | Other | Long chewing, Short chewing |
| High glycaemic load, low fibrous productTest-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. | Other | Long chewing, Short chewing |
Primary outcome
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
3 secondary outcomes
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
Amylase activity
Time frame: at day 1
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Derived from this study: PubMed 35773354Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diederik Esser, PhD principal investigator
Wageningen University and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low glycaemic load, high fibrous product and High glycaemic load, low fibrous product in people with Glucose, High Blood and Glucose, Low Blood, run by Wageningen University and Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose responses in the 3 hrs following lunch (time frame: 12 days in total to cover all test days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04648397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.