About this trial
This randomized cross-over pilot clinical trial aims to evaluate the feasibility and effect of a relaxing virtual reality (VR) experience on glucose response after white bread consumption, compared to a stress-inducing VR, a VR clinical room, and a real clinical room, in healthy adults. Participants will use a head-mounted display to experience either one of the VR environments, or they will simply sit in an actual clinical room for 15 minutes. After this pre-meal condition, participants will consume 66 grams of white bread within 10 minutes, accompanied by 250 mL of water. They will then continue their assigned pre-meal condition for one hour, followed by an additional hour of sitting in the lab for further assessments.
The feasibility of the study will be assessed by calculating: 1) Screening to randomization ratio, 2) Recruitment rate of participants per week, 3) Retention rate, 4) Data Completeness of Finger-Prick Glucose Measurements, and 5) VR intervention tolerability measured by Simulator Sickness Questionnaire (SSQ) score. Postprandial glucose response, stress levels, heart rate, and skin conductance will be assessed at baseline (15 minutes before white bread consumption), immediately before consumption (time 0), and at 15, 30, 45, 60, 90, and 120 minutes post-consumption. Palatability will be evaluated immediately after the meal consumption. Motivation to eat will also be assessed at 0, 15, 30, 45, 60, 90, and 120 minutes. Sense of presence will be measured immediately after VR exposure. Additionally, simulator sickness will be assessed at the beginning of the study and after VR exposure.
The results will help us better understand the potential feasibility and benefits of using relaxing VR for postprandial glucose management. These findings will also provide evidence to optimize the design of future definitive randomized clinical trials and enhance the development of VR interventions.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged between 18 and 50 years, of any sex.
Body mass index (BMI) between 18.9 and 29.9 kg/m².
Fasting blood glucose between 3.5 and 5.6 mmol/L.
They typically consume breakfast as part of their regular routine.
Disqualifiers
None
Trial design
Crossover
Treatments tested in this trial
A relaxing VR environment
DeviceThe TRIPP application, a relaxing VR environment that provides an immersive mindfulness.
A stress-inducing VR game
Device"Affected: The Manor Complete Edition," which is a horror-themed VR game involving a walk-through of a haunted house designed to evoke stress (Positive control).
A VR clinical room
DeviceA VR clinical room resembling the real clinical room as a sham control
A non-VR clinical room
Other interventionA non-VR clinical room (real clinical environment).
Treatment groups
Trial outcomes
Primary outcomes
The feasibility of VR interventions for blood glucose response to food
The feasibility of VR interventions for blood glucose response to food will be evaluated using a predefined red-yellow-green progression framework. This framework assesses five key feasibility metrics related to the study: screening to randomization ratio, recruitment rate, retention, data completeness of finger-prick glucose measurements, and VR intervention tolerability. Each metric will be judged against the three zones: green indicates feasibility, yellow suggests that modifications are needed, and red signifies that the trial is not feasible for a larger study in its current design.
Secondary outcomes
Postprandial glucose response
We will use a calibrated finger-prick device to measure blood glucose concentration.
Stress levels
Stress level will be assessed using the Visual Analog Scale (VAS), a 10-cm line on which 0 indicates the lowest level of stress and 10 indicates the highest.
Skin conductance
MINDFILD@ eSence Skin Response Units will be used to evaluate skin conductance
Heart rate
MINDFILD@ eSense PULSE-Heart Rate Variability sensors will be used for heart rate.
Sponsors and contacts
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