Blood sugar variations in daily life

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.



Objective:

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.



Study design:

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. Furthermore, the participant is asked to register their food intake and score their wellbeing using a smartphone app.



Study population:

All 24 participants will be employed 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).



Intervention:

In the first week of the pilot the participants are asked to perform an Oral Glucose Tolerance Test (OGTT). The participant is asked to fast for at least 10 hours before the OGTT drink is consumed. During the remaining days of the study, the participant can mostly follow their normal dietary pattern. Participants will be supplied with some standardized snacks, to improve comparability within and between participants.



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.

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 study will last two weeks.

Physical activity, sleep and glucose will be measured continuously (CGM sensor and a Philips research device called ELAN sensor). Food intake will be assessed daily (self-reporting of all meals in a Smartphone application).

Well-being will be assessed four times per day via a Smartphone application (breakfast, lunch, afternoon, evening).

OGTT will be performed once in the first study week, 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.

Not applicable