Relaxing VR and glucose response after white bread in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a randomized crossover design, healthy adults will experience a relaxing VR, a stress-inducing VR, a VR clinical room, or a non-VR clinical room for 15 minutes before eating 66 g of white bread with 250 mL water. After the pre-meal condition, participants will remain in the assigned environment for a total of one hour before and one hour after the meal, during which blood glucose and other measures are collected. Feasibility will be assessed by screening-to-randomization ratio, recruitment rate, retention, data completeness of finger-prick glucose, and tolerability of the VR interventions.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Manitoba
  Winnipeg, Manitoba, Canada Recruiting

Study contacts

• Principal investigator: Dylan MacKay, PhD — University of Manitoba
• Study coordinator: Dylan MacKay, PhD
• Email: dylan.mackay@umanitoba.ca
• Phone: +1 204-272-3119

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.