Variation in Food Intakes, Physical Activity, and Psychological Stress on Fluctuations in 24-hr Plasma Glucose Levels

NCT04522063 | Completed

• 1 other identifier: 2018/01220
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

This research has the following specific objectives:

1. 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. 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. 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. 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.

Conditions

Adults

Keywords

Eating behaviour; Eating rate; Glycaemic response; Satiety

Outcome Measures

Primary Outcomes (17)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Self-reported physical activity

  Self-reported physical activity through entering of activity type and duration via mobile phone application

  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.

  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).

  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.

  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).

  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).

  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.

  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.

  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.

  After study completion, up to 24 weeks

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults in Singapore with higher risk of type 2 diabetes

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead
• National University of Singapore, Saw Swee Hock School of Public Health: collaborator
• National University Hospital, Singapore: collaborator

Study Sites (2)

National University Hospital, Centre for Translational Medicine

Singapore, 117599, Singapore

Location

Singapore Institute of Food and Biotechnology Innovation (SIFBI)/Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

Related Publications (1)

• 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.

  PMID: 33389082 DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Rob Martinus van Dam, PhD

  rob.van.dam@nus.edu.sg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Principal Investigator

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 21, 2020
• Study Start: July 29, 2019
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: August 21, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)