Recruiting

Relaxing VR

Sponsor:

University of Manitoba

Code:

NCT07541794

Conditions

Post Prandial Blood Glucose

Feasibility Pilot Study

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

A relaxing VR environment

A stress-inducing VR game

A VR clinical room

A non-VR clinical room

Study Details

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.

Conditions

Post Prandial Blood Glucose

Feasibility Pilot Study

Study ID

NCT07541794

Start date

Sep 4, 2026

Status verified date

Sep, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Feb 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: A relaxing VR environment

active comparator: A stress-inducing VR game

sham comparator: A VR clinical room

other: A non-VR clinical room

Interventions

A relaxing VR environment

The TRIPP application, a relaxing VR environment that provides an immersive mindfulness.

A 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).

A VR clinical room

A VR clinical room resembling the real clinical room as a sham control

A non-VR clinical room

A non-VR clinical room (real clinical environment).

Primary outcome measure

  • The feasibility of VR interventions for blood glucose response to food [ Time Frame: Feasibility will be measured through study completion, an average of 4 weeks. ]

Central Contacts and Locations

Central contacts

Dylan MacKay, PhD

+1 204-272-3119dylan.mackay@umanitoba.ca

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3T 2N2

Contacts

Dylan MacKay

2047828124dylan.mackay@umanitoba.ca

Principal Investigator:

Dylan MacKay, PhD

More Information

Sponsor

University of Manitoba

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of Manitoba on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.