Feasibility Pilot Study, Post Prandial Blood Glucose
Conditions
Brief summary
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.
Interventions
DEVICEA relaxing VR environment
The TRIPP application, a relaxing VR environment that provides an immersive mindfulness.
DEVICEA stress-inducing VR game
"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).
DEVICEA VR clinical room
A VR clinical room resembling the real clinical room as a sham control
OTHERA non-VR clinical room
A non-VR clinical room (real clinical environment).
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
CONTACTDylan MacKay, PhD
PRINCIPAL_INVESTIGATORDylan MacKay, PhD
University of Manitoba
Outcome results
None listed