Relaxing Virtual Reality Use and Blood Glucose Response to Food (ReViR) Study

• A relaxing VR environment (Device): The 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 (Device): A VR clinical room resembling the real clinical room as a sham control
• A non-VR clinical room (Other): A non-VR clinical room (real clinical environment).

Primary outcomes

• The feasibility of VR interventions for blood glucose response to food [Feasibility will be measured through study completion, an average of 4 weeks.]: 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 [Capillary blood glucose will be measured at baseline and periprocedural.]: We will use a calibrated finger-prick device to measure blood glucose concentration.
• Stress levels [Visual analog scale (VAS) measuring self-reported stress levels will be completed at the baseline and periprocedural.]: 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 [Skin conductance will be measured at baseline and periprocedural.]: MINDFILD@ eSence Skin Response Units will be used to evaluate skin conductance
• Heart rate [Heart rate will be measured at baseline and periprocedural.]: MINDFILD@ eSense PULSE-Heart Rate Variability sensors will be used for heart rate.
• Participants' sense of presence in VR [It will be measured immediately after exposure to VR environments]: Participants' sense of presence in VR will be evaluated using the iGroup Presence Questionnaire, a 14-item instrument with a 7-point scale ranging from -3 to +3, where -3 indicates strong disagreement and +3 indicates strong agreement with the statement
• Simulator sickness [It will be measured at the beginning and immediately after VR exposure.]: Simulator sickness will be assessed using the Simulator Sickness Questionnaire (SSQ), which includes sixteen items representing the severity of symptoms that may occur due to exposure to a VR environment, rated from none to severe.
• Palatability [The Visual Analog Scale (VAS) measuring self-reported palatability will be completed right after the consumption of the white bread meal.]: To measure palatability, a 3-item, self-reported questionnaire will be used. Each item can be answered with a Visual Analog Scale (VAS), a 10 cm line indicating the extent of the participant's feeling, while 0 represents the lowest possible rating and 10 represents the highest.
• Appetite [The visual analog scale (VAS) measuring self-reported appetite will be completed periprocedurally]: Appetite will be assessed using the Visual Analog Scale (VAS), a five-item questionnaire in which each item is represented by a 10 cm line indicating the extent of the participant's feeling. On each line, 0 represents the lowest possible rating and 10 represents the highest.

Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers

Participants must meet all of the following criteria to be eligible for the study:

1. Aged between 18 and 50 years, of any sex.
2. Body mass index (BMI) between 18.9 and 29.9 kg/m².
3. Fasting blood glucose between 3.5 and 5.6 mmol/L.
4. They typically consume breakfast as part of their regular routine.
5. Willing and able to provide written informed consent.
6. In the opinion of the Investigator, the participant is capable of understanding and adhering to all study requirements.

Participants will be excluded if they meet any of the following conditions:

1. Fasting blood glucose ≥ 5.6 mmol/L or < 3.5 mmol/L.
2. Medical conditions that contraindicate the use of virtual reality (VR) headsets, including panic disorders, seizure disorders, migraines, certain vision impairments, or VR-related motion sickness.
3. A history of allergy or adverse reaction to white bread.
4. Current adherence to a special diet or use of supplements/medications that may affect carbohydrate metabolism, heart rate, or the nervous system within the last 6 months.
5. Medical history of hypertension, HIV/AIDS, hepatitis, type 1 or type 2 diabetes, cardiovascular or pulmonary diseases, or gastrointestinal disorders impacting carbohydrate metabolism.
6. Major physical injury or surgical procedure within the last 3 months.
7. Participation in any other randomized controlled trial within the previous 3 months.
8. Currently pregnant, breastfeeding, or planning to become pregnant during the study period.
9. Being unable to consume the test meal within the required 10-minute timeframe.
10. History of cancer within the past two years, excluding non-melanoma skin cancers.
11. Current or recent (within 12 months) excessive alcohol use defined as more than 14 standard drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz spirits).
12. Significant weight change (gain or loss exceeding 3.5 kg) in the past 3 months.
13. Inability to provide written informed consent.

• Dylan MacKay, PhD, Principal investigator, University of Manitoba