Adults Clinical Trial
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:
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 variation in blood glucose concentrations throughout the day. These results can
identify potential targets for interventions to reduce excessive fluctuations in blood
glucose concentrations.
2. 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.
3. 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.
4. 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.
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
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