Adults Clinical Trial
Official title:
Impact of Variation in Food Intakes, Physical Activity, and Psychological Stress on Fluctuations in 24-hr Plasma Glucose Levels
NCT number | NCT04522063 |
Other study ID # | 2018/01220 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 29, 2019 |
Est. completion date | February 10, 2020 |
Verified date | August 2020 |
Source | Clinical Nutrition Research Centre, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | February 10, 2020 |
Est. primary completion date | February 10, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Singapore | National University Hospital, Centre for Translational Medicine | Singapore | |
Singapore | Singapore Institute of Food and Biotechnology Innovation (SIFBI)/Clinical Nutrition Research Centre | Singapore |
Lead Sponsor | Collaborator |
---|---|
Clinical Nutrition Research Centre, Singapore | National University Hospital, Singapore, National University of Singapore, Saw Swee Hock School of Public Health |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). |
Baseline measure | |
Primary | 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). |
Baseline measure | |
Primary | 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). |
Baseline measure | |
Primary | 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). |
Baseline measure | |
Primary | 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). |
Baseline measure | |
Primary | 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). |
10 days | |
Primary | 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). |
10 days | |
Primary | 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 | 10 days | |
Primary | Self-reported physical activity | Self-reported physical activity through entering of activity type and duration via mobile phone application | 10 days | |
Primary | 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. | 10 days | |
Primary | 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). |
During test session 1 (day 1), up to 2 hours | |
Primary | 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. | During test session 1 (day 1), up to 2 hours | |
Primary | 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). |
During test session 1 (day 1), up to 15 minutes | |
Primary | 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). |
During test session 1 (day 1), up to 15 minutes | |
Primary | 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. |
During test session 2 (day 11), up to 1 hour | |
Primary | 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. |
During test session 2 (day 11), up to 1 hour | |
Primary | 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. |
After study completion, up to 24 weeks |
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