Blood sugar variations in daily life|
|- candidate number||29102|
|- NTR Number||NTR7322|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-jul-2018|
|- Secondary IDs||NL66268.028.18 P1828|
|- Public Title||Blood sugar variations in daily life|
|- Scientific Title||Understanding of glycemic response using contextual data and modeling – a pilot study|
|- hypothesis||The primary goal is to obtain and investigate the added value of real life high quality contextual data (e.g. food intake, physical activity, sleep, wellbeing) to understand and predict the fluctuations in individual glucose levels. |
|- Healt Condition(s) or Problem(s) studied||Glucose, Health, Self-monitoring|
|- Inclusion criteria||In order to be eligible to participate in this study a subject must be: |
• A researcher in the field of nutrition or health
• Aged between 20 – 55
• In possession of a Smartphone running on iOS or Android.
• Able and willing to sign the informed consent form
• Willing to comply with all study procedures
|- Exclusion criteria||A potential subject who meats any of the following criteria will be excluded from participation in this study:|
• Diabetes type 2 patients, and/or people with a finger-prick glucose value ≥ 7.8 mmol/l during screening.
• BMI > 30
• Under treatment for neurological or psychiatric complaints, including eating disorders
• Specific dietary preferences, including vegan, raw food, paleo. Vegetarian, pescatarians and flexitarians can participate in the study
• Coeliac disease or gluten intolerance
• Skin allergy, eczema or known sensitivity for plasters
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||24-sep-2018|
|- planned closingdate||8-okt-2018|
|- Target number of participants||24|
|- Interventions||Not applicable|
|- Primary outcome||The primary study parameters are:|
- Daily food intake
- Daily glucose levels
- Activity patterns
|- Secondary outcome||The secondary outcomes are:
- Lifestyle questionnaire at baseline|
- Satiety questionnaire after the OGTT
- User experiences, after the study the user experience will be measured using a questionnaire. Overall, the questionnaire includes self-constructed scales that measure user experience with the research in general and self-monitoring devices
|- Timepoints||The study will last two weeks. |
Physical activity, sleep and glucose will be measured continuously (CGM sensor and physical activity tracker). Food intake will be assessed daily (self-reporting of all mails).
Well-being will be assessed four times per day via a Smartphone application (breakfast, lunch, afternoon, evening).
OGTT will be performed at day 1, combined with a satiety questionnaire.
Lifestyle questionnaire will be filled out at baseline (t=0) and after two weeks. User experience questionnaire will be filled out after two weeks.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||PhD Marjan van Erk|
|- CONTACT for SCIENTIFIC QUERIES||MSc Iris de Hoogh|
|- Sponsor/Initiator ||TKI Agri & Food|
(Source(s) of Monetary or Material Support)
|Ministry of Economic Affairs, Philips Healthcare, Jumbo, Wageningen UR, OME Health, Noldus|
|- Brief summary||Many people in the Western world have an unhealthy lifestyle, including an unhealthy dietary pattern. Numerous approaches have been taken to stimulate people to maintain a healthier diet, but results are highly variable across studies and subjects. One explanation for this is that in many approaches the individuals' specific needs and the context they live and work in are not sufficiently taken into account. For an approach to be more effective, personal characteristics need to be considered. In other words, the approach needs to be tailored or personalized. To provide personalized advice to an individual based on their glucose response and wellbeing in relation to food intake, the individual responses to food intakes must be known. At this point, real-world data on intra-individual variability in glucose responses to a specific food product is lacking.
The primary goal is to obtain and investigate the added value of real-life high quality contextual data (e.g. food intake, physical activity, sleep, wellbeing) to understand and predict the fluctuations in individual glucose levels. The secondary objective is to define what metrics of glucose profiles can best be used to personalize lifestyle recommendations with respect to food intake and physical activity.
This study is designed as an observational pilot study. For 14 days, the participants will wear a continuous glucose monitor (CGM) to self-monitor their glucose levels. Additionally, their activity patterns, heart rate and sleep quality and quantity are monitored using a smartwatch. Furthermore, the participant is asked to register their food intake and score their wellbeing using a smartphone app.
All 24 participants will be researchers in the field of nutrition and health and will be selected from the Werkgroep Voedingsgewoonten (WeVo), Nederlandse Academie Voedingswetenschappen (NAV), and the Wageningen University (WUR).
On the first morning of the pilot the participants are asked to drink an Oral Glucose Tolerance Test (OGTT). The participant is asked to fast for at least 10 hours before the OGTT is consumed. During the remaining days of the study, the participant can follow their normal dietary pattern.
Main study parameters/endpoints:
Primary endpoints are self-monitored daily food intake, glucose levels, wellbeing, physical activity and sleep patterns.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The risks associated with participation can be considered negligible and the burden can be considered minimal. Glucose levels will be measured for two weeks using a validated, commercially available minimally invasive glucose monitoring sensor. Benefits include that participants can get more insight in their individual health behavior and status by self-monitoring food intake, glucose levels, wellbeing and physical activity.
|- Main changes (audit trail)|
|- RECORD||2-jul-2018 - 12-jul-2018|
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