Impact of Variation in Food Intakes, Physical Activity, and Psychological Stress on Fluctuations in 24-hr Plasma Glucose Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Oral processing behaviours of test meal
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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/m
- •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
排除标准
- •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.
结局指标
主要结局
Oral processing behaviours of test meal
时间窗: 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 3 test foods
时间窗: 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.
Physical activity
时间窗: 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).
Self-reported food intake
时间窗: 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
时间窗: 10 days
Self-reported physical activity through entering of activity type and duration via mobile phone application
Blood glucose concentrations in response to standardized mixed meal tolerance test
时间窗: 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).
Habitual dietary habit
时间窗: 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 sleep quality
时间窗: 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
时间窗: 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).
Compliance (response frequency) to multiple repeated self-reported measures
时间窗: 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.
Glucose concentration
时间窗: 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).
Reported satiety in response to standardized mixed meal tolerance test
时间窗: 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.
Habitual food intake behaviour
时间窗: 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
时间窗: 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).
Self-reported stress level
时间窗: 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.
Saliva properties of test meal
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Ciaran Forde
Senior Principal Investigator
Clinical Nutrition Research Centre, Singapore