AdultsTERAGINCT04683432
The Texture, Eating Rate and Glycaemic Index (TERAGI) Study
An observational study of Adults, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
Rationale: It is now recognized that diet plays a critical role in the etiology and management of chronic diseases such as type-2 diabetes, obesity and cardiovascular diseases. Evidence shows an increasing prevalence of type-2 diabetes as well as obesity, whereby large consumptions of carbohydrate foods is one of the… Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adults
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 2 May 2019to 15 Jul 2019
- Phase
- Observational
- 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 21 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Males of Chinese ethnicity and aged between 21 to 40 years old.
Who may be able to join
- Male
- Chinese ethnicity
- Age between 21-40 years
- Weigh at least 45 kg
- Body mass index between 18to 25 kg/m²
- Normal blood pressure (</=140/90 mmHg)
Show all 9Show fewer
- Fasting blood glucose <6.0 mmol/L
- Healthy dentition and ability to bite, chew and swallow normally
- No history of pain or discomfort in jaw movements or excessive teeth clenching or grinding, no caries or periodontal disease and no impaired salivation functions
Who cannot join
- Partake in sports at the competitive and/or endurance levels
- Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Have known history of anaemia or thalassemia minor
- Have major chronic disease such as heart disease, cancer or diabetes mellitus
- Take insulin or drugs known to affect glucose metabolism
- Intentionally restrict food intake
Show all 17Show fewer
- Have major medical or surgical event requiring hospitalization within the preceding 3 months
- Have taken antibiotics for 3 months before the study period
- Smoker
- Overnight shift worker
- Have any known food allergy (eg. anaphylaxis to peanuts)
- Have an active Tuberculosis (TB) condition or currently receiving treatment for TB
- Have any known Chronic Infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus(HCV), Human Immunodeficiency Virus (HIV)
- Member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
- Enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC
- Have poor veins impeding venous access
- Have any history of severe vasovagal syncope (blackouts or near faints) following blood draws
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Singapore Institute of Food and Biotechnology Innovation (SIFBI)/Clinical Nutrition Research Centre
Singapore, 117599
About this study
Rationale: It is now recognized that diet plays a critical role in the etiology and management of chronic diseases such as type-2 diabetes, obesity and cardiovascular diseases. Evidence shows an increasing prevalence of type-2 diabetes as well as obesity, whereby large consumptions of carbohydrate foods is one of the leading contribution to these diseases. Food structure and texture can be modified to control oral processing behaviour, which would have subsequent impact on total energy intake and glycaemic response through altering the food breakdown path. Whilst it has been demonstrated that foods which are eaten at a faster rate leads to more food consumed ad-libitum and therefore higher energy intake, they are also eaten at fewer chews per bite, resulting in larger food particle sizes and hence slower digestion. Therefore it is important to understand the overall net effect of the opposing outcomes of food texture and oral processing behavior, bolus properties and glycaemic response, and identify the key factors which has the biggest influence on glycaemic response. The findings from this study can be used as guidelines on meal planning and making better informed choices between foods which are of the same composition/nutrition but with different health outcomes.
Study Aims: The aim of this study is to understand how food texture and saliva characteristics influences oral processing behavior, bolus characteristics and postprandial glycaemic response.
Read more
Study Design: Randomised crossover design where participants receive 2 treatments (i.e. 2 test meals) over 2 test sessions. Test sessions will include bolus characterisation of foods where participants chew and expectorate test foods (5g each) based on a fixed chew protocol.
Study Population: Up to 40 healthy males aged 21-50 years with BMI between 18-25 kg/m2
Intervention: For test session 1 and 2, participants will receive 2 treatments (i.e. 2 test meals) in randomised order over 2 sessions. The test meals contain 50g carbohydrate load of different textures. Participants will be video recorded while consuming the test meals to derive oral processing behaviour (bites, chews, time food spent in mouth). Blood samples will be collected at baseline and post consumption (5, 10, 15, 30, 45, 60, 90, 120 minutes) to measure glycaemic responses to the test meals. For test session 3, participants will be asked to follow a fixed chew protocol to chew and expectorate 3 test foods while being video recorded. Similarly, oral processing behaviours will be analysed from the recorded videos. The spat out food samples (i.e. bolus samples) will be analysed for saliva uptake and bolus particle size indicating extent of food breakdown.
Read the detailed description
Study Aims:
The aim of this study is to understand how food texture and saliva characteristics influences oral processing behavior, bolus characteristics and postprandial glycaemic response.
The study hypothesizes that foods with a more elastic texture are eaten slower and requires more chewing, resulting in smaller bolus particle sizes and therefore higher postprandial glycaemic response due to an increased surface area for enzymatic digestion. Participants with higher saliva flowrate and/or alpha-amylase activity would also have shorter eating times and higher postprandial glycaemic responses.
Study Design:
Oral processing behaviours have high individual variances (Bolhuis et al 2013; Ketel et al 2019) and a large sample size is required in order to get significant differences between treatments. Based on previous papers on food texture and oral processing, a minimum of 20 healthy young male Chinese participants will be recruited in this study.
The study will require participants to attend 1 screening session (1 hour) and 3 test sessions (3 hours for test sessions 1 and 2; 1 hour for test session 3).
Screening (1 hour):
All potential participants will be asked to give informed consent before taking part in any of the research activities. Baseline measurements including anthropometric (height, weight, percentage body fat using a Bioelectrical Impedance Analyser), fasting blood glucose via finger prick and blood pressure will be taken to access eligibility.
Successfully screened participants will proceed to complete intraoral volume capacity measured using simple sip-and-spit measures, as well as provide stimulated and unstimulated saliva sample (approximately 4 x 5 ml each) via passive drooling to assess their saliva flowrates and saliva alpha-amylase activity.
Test Foods:
Commercially available and commonly consumed foods (e.g. white rice, korean rice cake, carrot, biscuits, etc.) are safe for human consumption and prepared in line with safe hygienic food preparation
Test session 1 and 2 (3 hours each):
Participants will be informed to fast 10 to 12 hours prior to test session 1 and 2. They are required to arrive the test centre between 08:00 - 09:00 a.m.
Participants will be asked to consume a test meal during each session, consisting of a 'fast' (less elastic texture and eaten more quickly) or 'slow' food (more elastic texture and eaten more slowly) in total. The order of test foods presented will be randomised. These test foods will be of the same carbohydrate load (50g carbohydrate) with different textures (i.e. white rice vs. rice cakes).
A baseline finger prick blood sample will be taken. After obtaining the baseline blood samples, test meal will be given to the participant to consumed within 15 minutes while being video recorded using a laptop webcam at face level. Following consumption of the test meal, finger prick blood samples will be taken for the next 5, 10, 15, 30, 45, 60, 90 and 120 minutes. The amount of blood that will be collected at every time point will be about a drop of blood (approximately 0.5ml per time point and 5 ml in total).
Sensory and textural ratings of the test meal will be taken using a visual analogue scale on a laptop. Post-meal satiety responses using a visual analogue scale will also be collected on a laptop every 15 minutes.
After completion of blood collection and satiety responses, the participant will be asked to chew on a separate portion of test meal (5g) until ready to swallow, and will be asked to expectorate the food bolus to assess their bolus properties including saliva uptake and particle size distribution. Video-recordings of the participant chewing the test foods will be taken.
A set of ad-libitum snacks will be provided to participants after all the measurements have been completed.
Test sessions 1 and 2 will be interspaced by a minimum of 5 days.
Test session 3 (1 hour):
Participants will be asked to chew on 3 test foods (white rice, rice cake, raw carrot) using a fixed chew protocol (i.e. 15 chews, 30 chews and chew until point of first swallow) and then expectorating the bolus to assess their bolus properties including saliva uptake and particle size distribution. Video-recordings of the participant chewing the test foods will be taken.
Sessions 2 and 3 will be interspaced by a minimum of 1 day.
- Conditions
- Adults
- Keywords
- Eating behaviour, Eating rate, Glycaemic response, Texture, Satiety
- Medical subject headings
- Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral processing behaviour of test meal
Participants will be video-recorded to measure oral processing behaviour of the test meal (white rice or rice cake)
Measured: During test session 1 (up to 3 hours)
Oral processing behaviour of test meal
Participants will be video-recorded to measure oral processing behaviour of the test meals (white rice or rice cake)
Measured: During test session 2 (up to 3 hours)
Blood glucose response to test meal
Blood glucose response will be measured through blood samples collected via finger prick at baseline (i.e. 0 minute) and post consumption of test meal (white rice or rice cake). (i.e. 0 min, 5 min, 10 min, 15 min, 30 min, 45 min, 60 min, 90 min and 120 min (0.5ml blood each)).
Measured: During test session 1 (up to 3 hours)
Blood glucose response to test meal
Blood glucose response will be measured through blood samples collected via finger prick at baseline (i.e. 0 minute) and post consumption of test meal (white rice or rice cake). (i.e. 0 min, 5 min, 10 min, 15 min, 30 min, 45 min, 60 min, 90 min and 120 min (0.5ml blood each)).
Measured: During test session 2 (up to 3 hours)
Reported satiety in response to test meal
Meal satiety responses using a visual analogue scale (VAS) will be collected on a laptop every 15 minutes during pre- and post- consumption of test meal (white rice or rice cake). VAS is anchored at 'Not at all full' (0) to 'Extremely full' (100), where a higher score will indicate greater satiety.
Measured: During test session 1 (up to 3 hours)
Reported satiety in response to test meal
Meal satiety responses using a visual analogue scale (VAS) will be collected on a laptop every 15 minutes during pre- and post- consumption of test meal (white rice or rice cake). VAS is anchored at 'Not at all full' (0) to 'Extremely full' (100), where a higher score will indicate greater satiety.
Measured: During test session 2 (up to 3 hours)
Reported sensory and textural rating of test meal
Meal satiety responses after test meal (white rice or rice cake) is consumed will be assessed using a visual analogue scale (VAS) will be collected on a laptop every 15 minutes during test session 1. VAS is anchored at 'Not at all' (0) to 'Extremely' (100), where a higher score will indicate greater intensity.
Measured: During test session 1 (up to 3 hours)
Reported sensory and textural rating of test meal
Meal satiety responses after test meal (white rice or rice cake) is consumed will be assessed using a visual analogue scale (VAS) will be collected on a laptop every 15 minutes during test session 1. VAS is anchored at 'Not at all' (0) to 'Extremely' (100), where a higher score will indicate greater intensity.
Measured: During test session 2 (up to 3 hours)
Bolus characterisation of test meal
Bolus characterisation of the test meal will be assessed by having participants chew a fixed mouthful of the test meal (white rice or rice cake, 5g) until ready to swallow, then expectorating it in a cup.
Participants will be video-recorded to measure time and number of chews taken to swallow, before expectoration.
Measured: During test session 1 (up to 3 hours)
Bolus characterisation of test meal
Bolus characterisation of the test meal will be assessed by having participants chew a fixed mouthful of the test meal (white rice or rice cake, 5g) until ready to swallow, then expectorating it in a cup.
Participants will be video-recorded to measure time and number of chews taken to swallow, before expectoration.
Measured: During test session 2 (up to 3 hours)
Bolus characterisation of 3 test foods
Bolus characterisation of the test meals will be assessed by having participants chew a fixed mouthful of the test foods (5g) based on a fixed chew protocol, then expectorating it in a cup.
Participants will be video-recorded to measure time and number of chews taken to swallow, before expectoration.
Measured: During test session 3 (up to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start2 May 2019
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
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 AdultsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ciaran Forde, PhD, Principal investigator, Ciaran_Forde@sifbi.a-star.edu.sg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683432
- Sponsor's protocol ID
- 2018/01091
- Other IDs
- 2018
- Acronym
- TERAGI
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goh AT, Chatonidi G, Choy M, Ponnalagu S, Stieger M, Forde CG. Impact of Individual Differences in Eating Rate on Oral Processing, Bolus Properties and Post-Meal Glucose Responses. Physiol Behav. 2021 Sep 1;238:113495. doi: 10.1016/j.physbeh.2021.113495. Epub 2021 Jun 9.
PubMed 34116051
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Texture, Eating Rate and Glycaemic Index (TERAGI) Study
- ClinicalTrials.gov ID
- NCT04683432
- Acronym / sponsor ID
- TERAGI / 2018/01091
- Conditions
- Adults
- Keywords
- Eating behaviour, Eating rate, Glycaemic response, Texture, Satiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 2 May 2019 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 24 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.
Rationale: It is now recognized that diet plays a critical role in the etiology and management of chronic diseases such as type-2 diabetes, obesity and cardiovascular diseases. Evidence shows an increasing prevalence of type-2 diabetes as well as obesity, whereby large consumptions of carbohydrate foods is one of the leading contribution to these diseases. Food structure and texture can be modified to control oral processing behaviour, which would have subsequent impact on total energy intake and glycaemic response through altering the food breakdown path. Whilst it has been demonstrated that foods which are eaten at a faster rate leads to more food consumed ad-libitum and therefore higher energy intake, they are also eaten at fewer chews per bite, resulting in larger food particle sizes and hence slower digestion. Therefore it is important to understand the overall net effect of the opposing outcomes of food texture and oral processing behavior, bolus properties and glycaemic response, and identify the key factors which has the biggest influence on glycaemic response. The findings from this study can be used as guidelines on meal planning and making better informed choices between foods which are of the same composition/nutrition but with different health outcomes.
Study Aims: The aim of this study is to understand how food texture and saliva characteristics influences oral processing behavior, bolus characteristics and postprandial glycaemic response.
Study Design: Randomised crossover design where participants receive 2 treatments (i.e. 2 test meals) over 2 test sessions. Test sessions will include bolus characterisation of foods where participants chew and expectorate test foods (5g each) based on a fixed chew protocol.
Study Population: Up to 40 healthy males aged 21-50 years with BMI between 18-25 kg/m2
Intervention: For test session 1 and 2, participants will receive 2 treatments (i.e. 2 test meals) in randomised order over 2 sessions. The test meals contain 50g carbohydrate load of different textures. Participants will be video recorded while consuming the test meals to derive oral processing behaviour (bites, chews, time food spent in mouth). Blood samples will be collected at baseline and post consumption (5, 10, 15, 30, 45, 60, 90, 120 minutes) to measure glycaemic responses to the test meals. For test session 3, participants will be asked to follow a fixed chew protocol to chew and expectorate 3 test foods while being video recorded. Similarly, oral processing behaviours will be analysed from the recorded videos. The spat out food samples (i.e. bolus samples) will be analysed for saliva uptake and bolus particle size indicating extent of food breakdown.
Detailed description
Study Aims:
The aim of this study is to understand how food texture and saliva characteristics influences oral processing behavior, bolus characteristics and postprandial glycaemic response.
The study hypothesizes that foods with a more elastic texture are eaten slower and requires more chewing, resulting in smaller bolus particle sizes and therefore higher postprandial glycaemic response due to an increased surface area for enzymatic digestion. Participants with higher saliva flowrate and/or alpha-amylase activity would also have shorter eating times and higher postprandial glycaemic responses.
Study Design:
Oral processing behaviours have high individual variances (Bolhuis et al 2013; Ketel et al 2019) and a large sample size is required in order to get significant differences between treatments. Based on previous papers on food texture and oral processing, a minimum of 20 healthy young male Chinese participants will be recruited in this study.
The study will require participants to attend 1 screening session (1 hour) and 3 test sessions (3 hours for test sessions 1 and 2; 1 hour for test session 3).
Screening (1 hour):
All potential participants will be asked to give informed consent before taking part in any of the research activities. Baseline measurements including anthropometric (height, weight, percentage body fat using a Bioelectrical Impedance Analyser), fasting blood glucose via finger prick and blood pressure will be taken to access eligibility.
Successfully screened participants will proceed to complete intraoral volume capacity measured using simple sip-and-spit measures, as well as provide stimulated and unstimulated saliva sample (approximately 4 x 5 ml each) via passive drooling to assess their saliva flowrates and saliva alpha-amylase activity.
Test Foods:
Commercially available and commonly consumed foods (e.g. white rice, korean rice cake, carrot, biscuits, etc.) are safe for human consumption and prepared in line with safe hygienic food preparation
Test session 1 and 2 (3 hours each):
Participants will be informed to fast 10 to 12 hours prior to test session 1 and 2. They are required to arrive the test centre between 08:00 - 09:00 a.m.
Participants will be asked to consume a test meal during each session, consisting of a 'fast' (less elastic texture and eaten more quickly) or 'slow' food (more elastic texture and eaten more slowly) in total. The order of test foods presented will be randomised. These test foods will be of the same carbohydrate load (50g carbohydrate) with different textures (i.e. white rice vs. rice cakes).
A baseline finger prick blood sample will be taken. After obtaining the baseline blood samples, test meal will be given to the participant to consumed within 15 minutes while being video recorded using a laptop webcam at face level. Following consumption of the test meal, finger prick blood samples will be taken for the next 5, 10, 15, 30, 45, 60, 90 and 120 minutes. The amount of blood that will be collected at every time point will be about a drop of blood (approximately 0.5ml per time point and 5 ml in total).
Sensory and textural ratings of the test meal will be taken using a visual analogue scale on a laptop. Post-meal satiety responses using a visual analogue scale will also be collected on a laptop every 15 minutes.
After completion of blood collection and satiety responses, the participant will be asked to chew on a separate portion of test meal (5g) until ready to swallow, and will be asked to expectorate the food bolus to assess their bolus properties including saliva uptake and particle size distribution. Video-recordings of the participant chewing the test foods will be taken.
A set of ad-libitum snacks will be provided to participants after all the measurements have been completed.
Test sessions 1 and 2 will be interspaced by a minimum of 5 days.
Test session 3 (1 hour):
Participants will be asked to chew on 3 test foods (white rice, rice cake, raw carrot) using a fixed chew protocol (i.e. 15 chews, 30 chews and chew until point of first swallow) and then expectorating the bolus to assess their bolus properties including saliva uptake and particle size distribution. Video-recordings of the participant chewing the test foods will be taken.
Sessions 2 and 3 will be interspaced by a minimum of 1 day.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Males of Chinese ethnicity and aged between 21 to 40 years old.
Key inclusion criteria (9 listed)
- Male
- Chinese ethnicity
- Age between 21-40 years
- Weigh at least 45 kg
- Body mass index between 18to 25 kg/m²
Key exclusion criteria (17 listed)
- Partake in sports at the competitive and/or endurance levels
- Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Have known history of anaemia or thalassemia minor
- Have major chronic disease such as heart disease, cancer or diabetes mellitus
- Take insulin or drugs known to affect glucose metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oral processing behaviour of test meal
Time frame: During test session 1 (up to 3 hours)
Participants will be video-recorded to measure oral processing behaviour of the test meal (white rice or rice cake)
Oral processing behaviour of test meal
Time frame: During test session 2 (up to 3 hours)
Participants will be video-recorded to measure oral processing behaviour of the test meals (white rice or rice cake)
Blood glucose response to test meal
Time frame: During test session 1 (up to 3 hours)
Blood glucose response will be measured through blood samples collected via finger prick at baseline (i.e. 0 minute) and post consumption of test meal (white rice or rice cake). (i.e. 0 min, 5 min, 10 min, 15 min, 30 min, 45 min, 60 min, 90 min and 120 min (0.5ml blood each)).
Blood glucose response to test meal
Time frame: During test session 2 (up to 3 hours)
Blood glucose response will be measured through blood samples collected via finger prick at baseline (i.e. 0 minute) and post consumption of test meal (white rice or rice cake). (i.e. 0 min, 5 min, 10 min, 15 min, 30 min, 45 min, 60 min, 90 min and 120 min (0.5ml blood each)).
Reported satiety in response to test meal
Time frame: During test session 1 (up to 3 hours)
Meal satiety responses using a visual analogue scale (VAS) will be collected on a laptop every 15 minutes during pre- and post- consumption of test meal (white rice or rice cake). VAS is anchored at 'Not at all full' (0) to 'Extremely full' (100), where a higher score will indicate greater satiety.
Reported satiety in response to test meal
Time frame: During test session 2 (up to 3 hours)
Meal satiety responses using a visual analogue scale (VAS) will be collected on a laptop every 15 minutes during pre- and post- consumption of test meal (white rice or rice cake). VAS is anchored at 'Not at all full' (0) to 'Extremely full' (100), where a higher score will indicate greater satiety.
Reported sensory and textural rating of test meal
Time frame: During test session 1 (up to 3 hours)
Meal satiety responses after test meal (white rice or rice cake) is consumed will be assessed using a visual analogue scale (VAS) will be collected on a laptop every 15 minutes during test session 1. VAS is anchored at 'Not at all' (0) to 'Extremely' (100), where a higher score will indicate greater intensity.
Reported sensory and textural rating of test meal
Time frame: During test session 2 (up to 3 hours)
Meal satiety responses after test meal (white rice or rice cake) is consumed will be assessed using a visual analogue scale (VAS) will be collected on a laptop every 15 minutes during test session 1. VAS is anchored at 'Not at all' (0) to 'Extremely' (100), where a higher score will indicate greater intensity.
Bolus characterisation of test meal
Time frame: During test session 1 (up to 3 hours)
Bolus characterisation of the test meal will be assessed by having participants chew a fixed mouthful of the test meal (white rice or rice cake, 5g) until ready to swallow, then expectorating it in a cup. Participants will be video-recorded to measure time and number of chews taken to swallow, before expectoration.
Bolus characterisation of test meal
Time frame: During test session 2 (up to 3 hours)
Bolus characterisation of the test meal will be assessed by having participants chew a fixed mouthful of the test meal (white rice or rice cake, 5g) until ready to swallow, then expectorating it in a cup. Participants will be video-recorded to measure time and number of chews taken to swallow, before expectoration.
Bolus characterisation of 3 test foods
Time frame: During test session 3 (up to 1 hour)
Bolus characterisation of the test meals will be assessed by having participants chew a fixed mouthful of the test foods (5g) based on a fixed chew protocol, then expectorating it in a cup. Participants will be video-recorded to measure time and number of chews taken to swallow, before expectoration.
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 24 Dec 2020.
- Derived from this study: PubMed 34116051Goh AT, Chatonidi G, Choy M, Ponnalagu S, Stieger M, Forde CG. Impact of Individual Differences in Eating Rate on Oral Processing, Bolus Properties and Post-Meal Glucose Responses. Physiol Behav. 2021 Sep 1;238:113495. doi: 10.1016/j.physbeh.2021.113495. Epub 2021 Jun 9.
- 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.
Ciaran Forde, PhD principal investigator
Ciaran_Forde@sifbi.a-star.edu.sg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adults, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
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 9 inclusion and 17 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 24 Dec 2020. 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 Singapore. 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?
Oral processing behaviour of test meal (time frame: During test session 1 (up to 3 hours)). The study lists 11 primary outcomes in all. 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 NCT04683432, 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 24 Dec 2020.