AdultsNCT04522063
Variation in Food Intakes, Physical Activity, and Psychological Stress on Fluctuations in 24-hr Plasma Glucose Levels
An observational study of Adults, run by Singapore Institute of Food and Biotechnology Innovation at 2 sites in Singapore.
Trial summary
This research has the following specific objectives: 1. To elucidate how within-person variation in lifestyle factors affect fluctuations in blood glucose concentrations in individuals at high risk of diabetes.This study will elucidate how variation in food intakes, physical activity, and psychological stress affect… Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Adults
- How many people
- 33 participants
- Where
- 2 sitesSingapore
- Study dates
- 29 Jul 2019to 10 Feb 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults in Singapore with higher risk of type 2 diabetes
Who may be able to join
- Aged 21-60 years.
- One of the following : pre-diabetes (as determined by previous HbA1C test within the range 42-47mmol/mol), family history of diabetes (mother, father, brother, sister, son, or daughter), or BMI 25-30 kg/m2.
- Ownership of a compatible smartphone.
- Access to a data plan.
- Able to provide informed consent.
- Healthy dentition with ability to bite, chew and swallow normally
Who cannot join
- Known sensitivity to medical-grade adhesives
- Bleeding disorders
- Allergies to any ingredients of the standardised meal or test foods
- Pregnant or lactating women
- Participants who did not agree to be contacted for future research
- Participants with conditions: diabetes mellitus, hypertension or thyroid disease, myocardial infarction in the past year, cancer history, or psychosocial impairment.
- Participants taking aspirin for long-term medical conditions will be excluded.
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
National University Hospital, Centre for Translational Medicine
Singapore, 117599
Singapore Institute of Food and Biotechnology Innovation (SIFBI)/Clinical Nutrition Research Centre
Singapore, 117599
About this study
Official title: Impact of Variation in Food Intakes, Physical Activity, and Psychological Stress on Fluctuations in 24-hr Plasma Glucose Levels
This research has the following specific objectives:
- To elucidate how within-person variation in lifestyle factors affect fluctuations in blood glucose concentrations in individuals at high risk of diabetes.This study will elucidate how variation in food intakes, physical activity, and psychological stress affect variation in blood glucose concentrations throughout the day. These results can identify potential targets for interventions to reduce excessive fluctuations in blood glucose concentrations.
- To describe to what extent the response of individuals to a standardized meal tolerance test can predict real-life variation in blood glucose concentrations. This study will evaluate how much variation in glucose concentrations under real-life conditions can be explained by an individual's response to a standardized mixed meal tolerance test. This will provide insight into the relative importance of variation in dietary and other lifestyle behaviours on an individual's predisposition to higher blood glucose responses.
- To elucidate the role of oral processing behaviour and saliva properties on blood glucose concentrations. This study will elucidate whether variation in oral processing behaviours (e.g. number of chews taken, oro-sensory exposure time) and saliva properties (a-amylase activity, flow rate) predicts variation in blood glucose concentrations across individuals.
- To assess whether research collecting multiple repeated measures of food intake, activity, and stress is feasible in large-scale epidemiological studies.This study will provide important insights into the feasibility over the long-run to collect multiple repeated data points on lifestyle behaviours through mobile phone applications and 24-hour glucose and physical activity monitoring in large scale studies in the Singapore population.
Read the detailed description
This is an observational study in free-living participants over up to 14 consecutive days. The rationale is that this period will provide sufficient intra-individual data for exploring behavioural and psychological determinants of blood glucose fluctuation. Multiple repeated data points on lifestyle behaviours will be collected through mobile phone applications, and 24-hour glucose concentrations and physical activity will be monitored objectively over the study period.
STUDY DESIGN:
As this is a pilot study, 36 participants will be recruited with anticipated 15% dropout resulting in 30 remaining participants. The recruitment target is determined based on what is financially feasible and sufficient to meet the study aims.Hierarchical clustering will be used to identify subjects with similar continuous blood glucose trajectories over 1 week by classifying them into groups. Followed by assessing whether the group labels from the cluster analysis are associated with the variation in dietary intakes, physical activity and psychological stress using Chi-square test or Fisher Exact test where appropriate. To quantify the effect of specific events (e.g., dietary intake, physical activity and stress affect) on continuous blood glucose trajectory within the two hour window after an event, linear models with generalized estimating equations will be used, where the characteristics of the event, socio-demographic variables of the subject and time since event are predictors in the model while accounting for the correlations from repeated continuous blood glucose in the same individual from multiple events. This study will also assess whether the characteristics of the event and sociodemographic variables are potential effect modifiers on the association between time and continuous blood glucose. To allow for flexibility in modelling time and continuous blood glucose, smoothing spline will also be used.
RECRUITMENT:
Participants of the Singapore Population Health Studies cohort who have agreed to be contacted for other studies, will be contacted by telephone and invited to participate in the present study (Telephone script and screening questionnaire; and this will be done in compliance with Personal Data Protection Act (PDPA) 2012. Eligible participants will be invited to attend NUH Investigational Medicine Unit.
Participants will be instructed to refrain from strenuous exercise for 48 hours before the procedure, and to undergo overnight fasting (10-12 hours) before the start of the procedure. No alcohol may be consumed for 24 hours before the study procedure. Participants will be asked to refrain from taking Vitamin C, multivitamins, and aspirin during the eleven day study period.
TEST SESSION 1 (DAY 1):
The first study visit will take approximately 3 hours. At the clinic visit, informed consent will be obtained in a private space, a mobile phone application will be downloaded onto participants phones to ensure compatibility, and blood pressure, height, weight, and waist circumference measured. A continuous glucose monitor (Freestyle Libre; Abbott Diabetes Care, Witney, Oxon, UK) will be fitted on the upper part of their non-dominant arm. If the participant has a lot of arm hair, the area will be shaved. A waterproof plaster will be placed over the device.
A mixed meal tolerance test (MMTT) will be conducted. The duration of MMTT will last for about 2 out of the 3 hours allocated for test session 1. Participants will be asked to sit on a bed and a cannula will be fitted in one of the antecubital veins in the pit of the elbow on the participants arm with a 3-way stopper. A blood sample will be taken via the cannula. Participants will then be asked to ingest a standardized meal (fried rice). While eating the standardised meal, participants will be video-recorded using a laptop webcam at face-level. Post-meal satiety responses using a visual analogue scale will be collected on a laptop every 15 minutes. Blood samples will be collected via an antecubital catheter before eating (11ml) and then at 5 min, 10 min, 15 min, 30 min, 45 min, 60 min, 90 min and 120 min (8ml each) after completion of the meal. The total blood volume taken will be 65-75ml. Blood will be sent immediately to NUH Referral Lab for analyses.
Questionnaires will be administered on demographics and lifestyle, including usual diet (FFQ with frequency rating from "never or rarely" to "6+ a day") and physical activity (GPAQ Questionnaire-Yes/No and input of actual activity duration), eating behaviours (TFEQ Questionnaire on 4-point scale from "definitely true" to "definitely false"), alcohol consumption (Yes/No), smoking (Yes/No), stress (K10 on likert scale from "All of the time" to "None of the time", where higher score indicate greater stress), and sleep (Pittsburgh sleep quality index-input of sleep time and duration and questions on 4-point scale from "Not during the past month" to "Three or more times a week"). Glucose and level of daily physical activity will be monitored using a continuous glucose monitor sensor and a wrist worn accelerometer. Food intake, physical activity and sleep time will be recorded by participants through an ecological momentary assessment (EMA) survey pushed out via mobile phone application.
Oral processing behaviours and saliva properties of test meal bolus: Bolus particle size (oral processing behaviour measure) and saliva uptake (saliva properties) will be assessed by having participants will be asked to chew a fixed mouthful of the test meal until ready to swallow, then expectorating it in a cup. The duration of oral processing behaviours and saliva properties measures will last for about 10 minutes out of the 3 hours allocated for test session 1.
Once the MMTT is complete, vital signs (blood pressure and pulse rate) will be measured. The cannula will be removed, and pressure applied locally on the site of bleeding. Researchers will ensure the participant is feeling well and is not giddy before continuing with the protocol.
DAY 2 to 10 (OFF-SITE):
Participants will be instructed to wear the continuous glucose monitor sensor continuously for 10 days. Participants will be asked to scan the sensor with a reader device at least every 6 hours during waking hours, and immediately before and after sleeping. The reader display will be masked with a sticker so participants will not be able to see their glucose readings. Participants will also be fitted with a wrist-worn accelerometer (Actigraph - Model wGT3x+ BT), a small tamper-proof electronic device that can be worn on a non-removable strap on the wrist of the non-dominant hand. Although the accelerometer may be worn during showering and swimming, participants will be given one additional strap in case removal is required.Participants will be guided on use of the ecological momentary assessment (EMA) mobile phone application during the baseline visit, and be asked to record within the app, their food intake, physical activity, and sleep times. A trained interviewer will demonstrate how the use the app and the participant will have a chance to ask questions. Participants will receive a reminder via the app, and will be asked to start recording activities prospectively from day 4 of the study.
From day 4 onwards, participants will receive one-minute time-triggered surveys via the app up to six times per day in which participants will be asked about hunger levels, stress, and psychological states. A phone number and email address will be provided to participants for them to contact the study team if participants face problems during the study. Participants will also be issued with a paper handout with reminders about using the app and sensor. Participants with phone models that are discovered to be incompatible with the app during study visit 1 or later in the study period will be issued with a phone handset on which participants can complete lifestyle tracking and EMA surveys. At the end of day 4, participants will be telephoned and asked if participants experienced any technical issues. For issues that cannot be resolved over the telephone, participants will be asked to meet researchers at Saw Swee Hock School of Public Health, or a place of their convenience. If the issue relates to the glucose sensor, if necessary participants will be asked to restart the monitoring period, and will be fitted with a new glucose sensor.
TEST SESSION 2 (DAY 11):
The final study visit will occur on day 11 and will take approximately 2 hours. Participants' body composition will be measured using a BOD POD Gold Standard Body Composition Tracking System (COSMED, Concord, CA, USA) is an air displacement plethysmograph which uses whole-body densitometry to determine body composition (fat and fat-free mass). Participants will be asked to change into swimwear and sit inside the machine for 5 minutes. Participants will be provided with results on their body composition.
Oral processing behaviours and saliva properties: Saliva measures will be taken from the participant. Resting saliva will be taken by asking the participant to expectorate into a tube (approximately 5ml) while stimulated whole saliva samples will be collected by asking the participant to chew on a clean, non-toxic inert Parafilm square and expectorating over a period of 5 minutes (approximately 5-10ml). The duration for saliva measures in about 30 minutes. Mouth volume will be measured by asking the participants to take in the maximum volume of filtered water participants can hold and then expectorating it into a volumetric cylinder. Participants will also 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 oral processing behavior based on bolus properties including saliva uptake and particle size distribution. The duration is approximately 1 hour.
Participants will return the accelerometer, glucose monitor reader, and study phone (if issued). A research assistant will remove the glucose sensor from the participant's arm.
Before leaving the unit, participants will be asked to take part in a 15 minute open-ended interview about taking part in this research, focusing on their experiences using the glucose monitor and research app. Participants will receive a letter reporting the following measurements and results collected during the study: blood pressure, height, weight, BMI, HbA1C concentration, and fasting glucose concentration. The report will include information on interpreting the results, and occasions when it is advised to see a doctor
- Conditions
- Adults
- Keywords
- Eating behaviour, Eating rate, Glycaemic response, Satiety
- Medical subject headings
- Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Habitual dietary habit
Habitual dietary habits are measured using Food Frequency Questionnaire (FFQ) rating from "never or rarely" to "6+ a day", where 'never to rarely' means nil or scarce intake of the food item.
Data is collected as part of the procedure in test session 1 (total duration of 3 hours).
Measured: Baseline measure
Habitual food intake behaviour
Food intake behaviour is assessed using a Three-Factor Eating Questionnaire (TFEQ) using a 4-point scale from "definitely true" (4) to "definitely false" (1), where higher score means greater agreement to the statement asked.
Data is collected as part of the procedure in test session 1 (total duration of 3 hours).
Measured: Baseline measure
Habitual stress level
Stress level is assessed using a Kessler Psychological Distress Scale (K10) on likert scale from "All of the time" to "None of the time", where higher score indicates greater stress.
Data is collected as part of the procedure in test session 1 (total duration of 3 hours).
Measured: Baseline measure
Habitual sleep quality
Sleep Questionnaire (Pittsburgh sleep quality index), including the input of sleep time and duration and questions on 4-point scale from "Not during the past month" (1) to "Three or more times a week"(4), where higher score indicates poorer sleep quality.
Data is collected as part of the procedure in test session 1 (total duration of 3 hours).
Measured: Baseline measure
Habitual physical activity
Global Physical Activity Questionnaire (GPAQ) to evaluate on duration spent on different types of physical activity. Responses will be tabulated into MET, where higher MET refers to greater intensity of physical activity.
Data is collected as part of the procedure in test session 1 (total duration of 3 hours).
Measured: Baseline measure
Physical activity
Physical activity is measured using a wrist-worn accelerometer as part of lifestyle factors outcome.
Data will be collected over a period of 10 days after their clinic visit (session 1).
Measured: 10 days
Glucose concentration
Glucose concentrations is measured using a continuous glucose monitor sensor.
Data will be collected over a period of 10 days after their clinic visit (session 1).
Measured: 10 days
Self-reported food intake
Self-reported food intake measurement (food diary record) through entering of food items and amount consumed during meal via mobile phone application
Measured: 10 days
Self-reported physical activity
Self-reported physical activity through entering of activity type and duration via mobile phone application
Measured: 10 days
Self-reported stress level
Self-reported stress level will be assessed using questions on a 4-point likert scale reported at a 4-hour interval, from 'not at all' to 'very', where higher score means greater stress level.
Measured: 10 days
Blood glucose concentrations in response to standardized mixed meal tolerance test
Blood glucose response will be measured through blood samples collected via an antecubital catheter before eating and at respective time points after completion of standardized meal. (I.e. at 5 min, 10 min, 15 min, 30 min, 45 min, 60 min, 90 min and 120 min (8ml each)).
Data is collected as part of the procedure in test session 1 (total duration of 3 hours).
Measured: During test session 1 (day 1), up to 2 hours
Reported satiety in response to standardized mixed meal tolerance test
Meal satiety responses 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 full' (0) to 'Extremely full' (100), where a higher score will indicate greater satiety.
Measured: During test session 1 (day 1), up to 2 hours
Oral processing behaviours of test meal
Participants will be video-recorded to measure oral processing behaviour of the test meal.
Test meal bolus collection (test session 1): Bolus particle size (oral processing behaviour measure) will be assessed by having participants chew a fixed mouthful of the test meal until ready to swallow, then expectorating it in a cup.
Data is collected as part of the procedure in test session 1 (total duration of 3 hours).
Measured: During test session 1 (day 1), up to 15 minutes
Saliva properties of test meal
Participants will be video-recorded to measure oral processing behaviour of the test meal.
Test meal bolus collection (test session 1): Saliva uptake (saliva properties) will be assessed by having participants chew a fixed mouthful of the test meal until ready to swallow, then expectorating it in a cup.
Data is collected as part of the procedure in test session 1 (total duration of 3 hours).
Measured: During test session 1 (day 1), up to 15 minutes
Oral processing behaviours of 3 test foods
Participants will be video-recorded to measure oral processing behaviour.
Bolus collection of 3 food items (test session 2):
Bolus particle size (oral processing behaviour measure) of 3 food items will be assessed by having participants chew on 3 different test foods using a fixed protocol then expectorating it in a cup.
Measured: During test session 2 (day 11), up to 1 hour
Saliva properties of 3 test foods
Participants will be video-recorded to measure oral processing behaviour.
Bolus collection of 3 food items and saliva collection (test session 2):
Saliva uptake (saliva properties) of 3 food items will be assessed by having participants chew on 3 different test foods using a fixed protocol then expectorating it in a cup.
To measure saliva flow rate and amylase (saliva properties), resting saliva will be taken by asking the participant to expectorate into a tube (approximately 5ml) while stimulated whole saliva samples will be collected by chewing on a clean, non-toxic inert Parafilm square and expectorating over a period of 5 minutes.
Measured: During test session 2 (day 11), up to 1 hour
Compliance (response frequency) to multiple repeated self-reported measures
Response frequency (i.e. 5 out of 10 responses = 50%) of all self-administered measurements through a mobile phone application will be assessed.
At least 70% of completed data from each participant will be used as a benchmark to assess response compliance.
Measured: After study completion, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start29 Jul 2019
- Primary completion10 Feb 2020
- Study completion10 Feb 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 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Collaborators
- National University of Singapore, Saw Swee Hock School of Public Health, National University Hospital, Singapore
- Responsible party
- Principal investigator, Ciaran Forde, Singapore Institute of Food and Biotechnology Innovation
- Investigators
- Rob Martinus van Dam, PhD, Principal investigator, rob.van.dam@nus.edu.sg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522063
- Sponsor's protocol ID
- 2018/01220
- Other IDs
- 2018
- Status last verified
- Aug 2020
- First submitted
- 29 Jul 2020
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goh AT, Choy JYM, Chua XH, Ponnalagu S, Khoo CM, Whitton C, van Dam RM, Forde CG. Increased oral processing and a slower eating rate increase glycaemic, insulin and satiety responses to a mixed meal tolerance test. Eur J Nutr. 2021 Aug;60(5):2719-2733. doi: 10.1007/s00394-020-02466-z. Epub 2021 Jan 2.
PubMed 33389082
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Variation in Food Intakes, Physical Activity, and Psychological Stress on Fluctuations in 24-hr Plasma Glucose Levels
- ClinicalTrials.gov ID
- NCT04522063
- Acronym / sponsor ID
- 2018/01220
- Conditions
- Adults
- Keywords
- Eating behaviour, Eating rate, Glycaemic response, Satiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Collaborators
- National University of Singapore, Saw Swee Hock School of Public Health, National University Hospital, Singapore
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 21 Aug 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 research has the following specific objectives:
- To elucidate how within-person variation in lifestyle factors affect fluctuations in blood glucose concentrations in individuals at high risk of diabetes.This study will elucidate how variation in food intakes, physical activity, and psychological stress affect variation in blood glucose concentrations throughout the day. These results can identify potential targets for interventions to reduce excessive fluctuations in blood glucose concentrations.
- To describe to what extent the response of individuals to a standardized meal tolerance test can predict real-life variation in blood glucose concentrations. This study will evaluate how much variation in glucose concentrations under real-life conditions can be explained by an individual's response to a standardized mixed meal tolerance test. This will provide insight into the relative importance of variation in dietary and other lifestyle behaviours on an individual's predisposition to higher blood glucose responses.
- To elucidate the role of oral processing behaviour and saliva properties on blood glucose concentrations. This study will elucidate whether variation in oral processing behaviours (e.g. number of chews taken, oro-sensory exposure time) and saliva properties (a-amylase activity, flow rate) predicts variation in blood glucose concentrations across individuals.
- To assess whether research collecting multiple repeated measures of food intake, activity, and stress is feasible in large-scale epidemiological studies.This study will provide important insights into the feasibility over the long-run to collect multiple repeated data points on lifestyle behaviours through mobile phone applications and 24-hour glucose and physical activity monitoring in large scale studies in the Singapore population.
Detailed description
This is an observational study in free-living participants over up to 14 consecutive days. The rationale is that this period will provide sufficient intra-individual data for exploring behavioural and psychological determinants of blood glucose fluctuation. Multiple repeated data points on lifestyle behaviours will be collected through mobile phone applications, and 24-hour glucose concentrations and physical activity will be monitored objectively over the study period.
STUDY DESIGN:
As this is a pilot study, 36 participants will be recruited with anticipated 15% dropout resulting in 30 remaining participants. The recruitment target is determined based on what is financially feasible and sufficient to meet the study aims.Hierarchical clustering will be used to identify subjects with similar continuous blood glucose trajectories over 1 week by classifying them into groups. Followed by assessing whether the group labels from the cluster analysis are associated with the variation in dietary intakes, physical activity and psychological stress using Chi-square test or Fisher Exact test where appropriate. To quantify the effect of specific events (e.g., dietary intake, physical activity and stress affect) on continuous blood glucose trajectory within the two hour window after an event, linear models with generalized estimating equations will be used, where the characteristics of the event, socio-demographic variables of the subject and time since event are predictors in the model while accounting for the correlations from repeated continuous blood glucose in the same individual from multiple events. This study will also assess whether the characteristics of the event and sociodemographic variables are potential effect modifiers on the association between time and continuous blood glucose. To allow for flexibility in modelling time and continuous blood glucose, smoothing spline will also be used.
RECRUITMENT:
Participants of the Singapore Population Health Studies cohort who have agreed to be contacted for other studies, will be contacted by telephone and invited to participate in the present study (Telephone script and screening questionnaire; and this will be done in compliance with Personal Data Protection Act (PDPA) 2012. Eligible participants will be invited to attend NUH Investigational Medicine Unit.
Participants will be instructed to refrain from strenuous exercise for 48 hours before the procedure, and to undergo overnight fasting (10-12 hours) before the start of the procedure. No alcohol may be consumed for 24 hours before the study procedure. Participants will be asked to refrain from taking Vitamin C, multivitamins, and aspirin during the eleven day study period.
TEST SESSION 1 (DAY 1):
The first study visit will take approximately 3 hours. At the clinic visit, informed consent will be obtained in a private space, a mobile phone application will be downloaded onto participants phones to ensure compatibility, and blood pressure, height, weight, and waist circumference measured. A continuous glucose monitor (Freestyle Libre; Abbott Diabetes Care, Witney, Oxon, UK) will be fitted on the upper part of their non-dominant arm. If the participant has a lot of arm hair, the area will be shaved. A waterproof plaster will be placed over the device.
A mixed meal tolerance test (MMTT) will be conducted. The duration of MMTT will last for about 2 out of the 3 hours allocated for test session 1. Participants will be asked to sit on a bed and a cannula will be fitted in one of the antecubital veins in the pit of the elbow on the participants arm with a 3-way stopper. A blood sample will be taken via the cannula. Participants will then be asked to ingest a standardized meal (fried rice). While eating the standardised meal, participants will be video-recorded using a laptop webcam at face-level. Post-meal satiety responses using a visual analogue scale will be collected on a laptop every 15 minutes. Blood samples will be collected via an antecubital catheter before eating (11ml) and then at 5 min, 10 min, 15 min, 30 min, 45 min, 60 min, 90 min and 120 min (8ml each) after completion of the meal. The total blood volume taken will be 65-75ml. Blood will be sent immediately to NUH Referral Lab for analyses.
Questionnaires will be administered on demographics and lifestyle, including usual diet (FFQ with frequency rating from "never or rarely" to "6+ a day") and physical activity (GPAQ Questionnaire-Yes/No and input of actual activity duration), eating behaviours (TFEQ Questionnaire on 4-point scale from "definitely true" to "definitely false"), alcohol consumption (Yes/No), smoking (Yes/No), stress (K10 on likert scale from "All of the time" to "None of the time", where higher score indicate greater stress), and sleep (Pittsburgh sleep quality index-input of sleep time and duration and questions on 4-point scale from "Not during the past month" to "Three or more times a week"). Glucose and level of daily physical activity will be monitored using a continuous glucose monitor sensor and a wrist worn accelerometer. Food intake, physical activity and sleep time will be recorded by participants through an ecological momentary assessment (EMA) survey pushed out via mobile phone application.
Oral processing behaviours and saliva properties of test meal bolus: Bolus particle size (oral processing behaviour measure) and saliva uptake (saliva properties) will be assessed by having participants will be asked to chew a fixed mouthful of the test meal until ready to swallow, then expectorating it in a cup. The duration of oral processing behaviours and saliva properties measures will last for about 10 minutes out of the 3 hours allocated for test session 1.
Once the MMTT is complete, vital signs (blood pressure and pulse rate) will be measured. The cannula will be removed, and pressure applied locally on the site of bleeding. Researchers will ensure the participant is feeling well and is not giddy before continuing with the protocol.
DAY 2 to 10 (OFF-SITE):
Participants will be instructed to wear the continuous glucose monitor sensor continuously for 10 days. Participants will be asked to scan the sensor with a reader device at least every 6 hours during waking hours, and immediately before and after sleeping. The reader display will be masked with a sticker so participants will not be able to see their glucose readings. Participants will also be fitted with a wrist-worn accelerometer (Actigraph - Model wGT3x+ BT), a small tamper-proof electronic device that can be worn on a non-removable strap on the wrist of the non-dominant hand. Although the accelerometer may be worn during showering and swimming, participants will be given one additional strap in case removal is required.Participants will be guided on use of the ecological momentary assessment (EMA) mobile phone application during the baseline visit, and be asked to record within the app, their food intake, physical activity, and sleep times. A trained interviewer will demonstrate how the use the app and the participant will have a chance to ask questions. Participants will receive a reminder via the app, and will be asked to start recording activities prospectively from day 4 of the study.
From day 4 onwards, participants will receive one-minute time-triggered surveys via the app up to six times per day in which participants will be asked about hunger levels, stress, and psychological states. A phone number and email address will be provided to participants for them to contact the study team if participants face problems during the study. Participants will also be issued with a paper handout with reminders about using the app and sensor. Participants with phone models that are discovered to be incompatible with the app during study visit 1 or later in the study period will be issued with a phone handset on which participants can complete lifestyle tracking and EMA surveys. At the end of day 4, participants will be telephoned and asked if participants experienced any technical issues. For issues that cannot be resolved over the telephone, participants will be asked to meet researchers at Saw Swee Hock School of Public Health, or a place of their convenience. If the issue relates to the glucose sensor, if necessary participants will be asked to restart the monitoring period, and will be fitted with a new glucose sensor.
TEST SESSION 2 (DAY 11):
The final study visit will occur on day 11 and will take approximately 2 hours. Participants' body composition will be measured using a BOD POD Gold Standard Body Composition Tracking System (COSMED, Concord, CA, USA) is an air displacement plethysmograph which uses whole-body densitometry to determine body composition (fat and fat-free mass). Participants will be asked to change into swimwear and sit inside the machine for 5 minutes. Participants will be provided with results on their body composition.
Oral processing behaviours and saliva properties: Saliva measures will be taken from the participant. Resting saliva will be taken by asking the participant to expectorate into a tube (approximately 5ml) while stimulated whole saliva samples will be collected by asking the participant to chew on a clean, non-toxic inert Parafilm square and expectorating over a period of 5 minutes (approximately 5-10ml). The duration for saliva measures in about 30 minutes. Mouth volume will be measured by asking the participants to take in the maximum volume of filtered water participants can hold and then expectorating it into a volumetric cylinder. Participants will also 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 oral processing behavior based on bolus properties including saliva uptake and particle size distribution. The duration is approximately 1 hour.
Participants will return the accelerometer, glucose monitor reader, and study phone (if issued). A research assistant will remove the glucose sensor from the participant's arm.
Before leaving the unit, participants will be asked to take part in a 15 minute open-ended interview about taking part in this research, focusing on their experiences using the glucose monitor and research app. Participants will receive a letter reporting the following measurements and results collected during the study: blood pressure, height, weight, BMI, HbA1C concentration, and fasting glucose concentration. The report will include information on interpreting the results, and occasions when it is advised to see a doctor
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults in Singapore with higher risk of type 2 diabetes
Key inclusion criteria (6 listed)
- Aged 21-60 years.
- One of the following : pre-diabetes (as determined by previous HbA1C test within the range 42-47mmol/mol), family history of diabetes (mother, father, brother, sister, son, or daughter), or BMI 25-30 kg/m2.
- Ownership of a compatible smartphone.
- Access to a data plan.
- Able to provide informed consent.
Key exclusion criteria (7 listed)
- Known sensitivity to medical-grade adhesives
- Bleeding disorders
- Allergies to any ingredients of the standardised meal or test foods
- Pregnant or lactating women
- Participants who did not agree to be contacted for future research
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
Habitual dietary habit
Time frame: Baseline measure
Habitual dietary habits are measured using Food Frequency Questionnaire (FFQ) rating from "never or rarely" to "6+ a day", where 'never to rarely' means nil or scarce intake of the food item. Data is collected as part of the procedure in test session 1 (total duration of 3 hours).
Habitual food intake behaviour
Time frame: Baseline measure
Food intake behaviour is assessed using a Three-Factor Eating Questionnaire (TFEQ) using a 4-point scale from "definitely true" (4) to "definitely false" (1), where higher score means greater agreement to the statement asked. Data is collected as part of the procedure in test session 1 (total duration of 3 hours).
Habitual stress level
Time frame: Baseline measure
Stress level is assessed using a Kessler Psychological Distress Scale (K10) on likert scale from "All of the time" to "None of the time", where higher score indicates greater stress. Data is collected as part of the procedure in test session 1 (total duration of 3 hours).
Habitual sleep quality
Time frame: Baseline measure
Sleep Questionnaire (Pittsburgh sleep quality index), including the input of sleep time and duration and questions on 4-point scale from "Not during the past month" (1) to "Three or more times a week"(4), where higher score indicates poorer sleep quality. Data is collected as part of the procedure in test session 1 (total duration of 3 hours).
Habitual physical activity
Time frame: Baseline measure
Global Physical Activity Questionnaire (GPAQ) to evaluate on duration spent on different types of physical activity. Responses will be tabulated into MET, where higher MET refers to greater intensity of physical activity. Data is collected as part of the procedure in test session 1 (total duration of 3 hours).
Physical activity
Time frame: 10 days
Physical activity is measured using a wrist-worn accelerometer as part of lifestyle factors outcome. Data will be collected over a period of 10 days after their clinic visit (session 1).
Glucose concentration
Time frame: 10 days
Glucose concentrations is measured using a continuous glucose monitor sensor. Data will be collected over a period of 10 days after their clinic visit (session 1).
Self-reported food intake
Time frame: 10 days
Self-reported food intake measurement (food diary record) through entering of food items and amount consumed during meal via mobile phone application
Self-reported physical activity
Time frame: 10 days
Self-reported physical activity through entering of activity type and duration via mobile phone application
Self-reported stress level
Time frame: 10 days
Self-reported stress level will be assessed using questions on a 4-point likert scale reported at a 4-hour interval, from 'not at all' to 'very', where higher score means greater stress level.
Blood glucose concentrations in response to standardized mixed meal tolerance test
Time frame: During test session 1 (day 1), up to 2 hours
Blood glucose response will be measured through blood samples collected via an antecubital catheter before eating and at respective time points after completion of standardized meal. (I.e. at 5 min, 10 min, 15 min, 30 min, 45 min, 60 min, 90 min and 120 min (8ml each)). Data is collected as part of the procedure in test session 1 (total duration of 3 hours).
Reported satiety in response to standardized mixed meal tolerance test
Time frame: During test session 1 (day 1), up to 2 hours
Meal satiety responses 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 full' (0) to 'Extremely full' (100), where a higher score will indicate greater satiety.
Oral processing behaviours of test meal
Time frame: During test session 1 (day 1), up to 15 minutes
Participants will be video-recorded to measure oral processing behaviour of the test meal. Test meal bolus collection (test session 1): Bolus particle size (oral processing behaviour measure) will be assessed by having participants chew a fixed mouthful of the test meal until ready to swallow, then expectorating it in a cup. Data is collected as part of the procedure in test session 1 (total duration of 3 hours).
Saliva properties of test meal
Time frame: During test session 1 (day 1), up to 15 minutes
Participants will be video-recorded to measure oral processing behaviour of the test meal. Test meal bolus collection (test session 1): Saliva uptake (saliva properties) will be assessed by having participants chew a fixed mouthful of the test meal until ready to swallow, then expectorating it in a cup. Data is collected as part of the procedure in test session 1 (total duration of 3 hours).
Oral processing behaviours of 3 test foods
Time frame: During test session 2 (day 11), up to 1 hour
Participants will be video-recorded to measure oral processing behaviour. Bolus collection of 3 food items (test session 2): Bolus particle size (oral processing behaviour measure) of 3 food items will be assessed by having participants chew on 3 different test foods using a fixed protocol then expectorating it in a cup.
Saliva properties of 3 test foods
Time frame: During test session 2 (day 11), up to 1 hour
Participants will be video-recorded to measure oral processing behaviour. Bolus collection of 3 food items and saliva collection (test session 2): Saliva uptake (saliva properties) of 3 food items will be assessed by having participants chew on 3 different test foods using a fixed protocol then expectorating it in a cup. To measure saliva flow rate and amylase (saliva properties), resting saliva will be taken by asking the participant to expectorate into a tube (approximately 5ml) while stimulated whole saliva samples will be collected by chewing on a clean, non-toxic inert Parafilm square and expectorating over a period of 5 minutes.
Compliance (response frequency) to multiple repeated self-reported measures
Time frame: After study completion, up to 24 weeks
Response frequency (i.e. 5 out of 10 responses = 50%) of all self-administered measurements through a mobile phone application will be assessed. At least 70% of completed data from each participant will be used as a benchmark to assess response compliance.
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 21 Aug 2020.
- Derived from this study: PubMed 33389082Goh AT, Choy JYM, Chua XH, Ponnalagu S, Khoo CM, Whitton C, van Dam RM, Forde CG. Increased oral processing and a slower eating rate increase glycaemic, insulin and satiety responses to a mixed meal tolerance test. Eur J Nutr. 2021 Aug;60(5):2719-2733. doi: 10.1007/s00394-020-02466-z. Epub 2021 Jan 2.
- 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.
Rob Martinus van Dam, PhD principal investigator
rob.van.dam@nus.edu.sg
2 sites 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 2 sites 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 6 inclusion and 7 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 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Habitual dietary habit (time frame: Baseline measure). The study lists 17 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 NCT04522063, 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 21 Aug 2020.