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

Обзор

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.

Вмешательства

• Устройство A relaxing VR environment
  The TRIPP application, a relaxing VR environment that provides an immersive mindfulness.
• Устройство 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).
• Устройство A VR clinical room
  A VR clinical room resembling the real clinical room as a sham control
• Другое A non-VR clinical room
  A non-VR clinical room (real clinical environment).

Первичные конечные точки

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

Вторичные конечные точки (8)

• Postprandial glucose response [Срок оценки: Capillary blood glucose will be measured at baseline and periprocedural.]
• Stress levels [Срок оценки: Visual analog scale (VAS) measuring self-reported stress levels will be completed at the baseline and periprocedural.]
• Skin conductance [Срок оценки: Skin conductance will be measured at baseline and periprocedural.]
• Heart rate [Срок оценки: Heart rate will be measured at baseline and periprocedural.]
• Participants' sense of presence in VR [Срок оценки: It will be measured immediately after exposure to VR environments]
• Simulator sickness [Срок оценки: It will be measured at the beginning and immediately after VR exposure.]
• Palatability [Срок оценки: The Visual Analog Scale (VAS) measuring self-reported palatability will be completed right after the consumption of the white bread meal.]
• Appetite [Срок оценки: The visual analog scale (VAS) measuring self-reported appetite will be completed periprocedurally]

Критерии участия

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

• 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.
• Willing and able to provide written informed consent.
• 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:

• Fasting blood glucose ≥ 5.6 mmol/L or < 3.5 mmol/L.
• 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.
• A history of allergy or adverse reaction to white bread.
• 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.
• Medical history of hypertension, HIV/AIDS, hepatitis, type 1 or type 2 diabetes, cardiovascular or pulmonary diseases, or gastrointestinal disorders impacting carbohydrate metabolism.
• Major physical injury or surgical procedure within the last 3 months.
• Participation in any other randomized controlled trial within the previous 3 months.
• Currently pregnant, breastfeeding, or planning to become pregnant during the study period.
• Being unable to consume the test meal within the required 10-minute timeframe.
• History of cancer within the past two years, excluding non-melanoma skin cancers.
• 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).
• Significant weight change (gain or loss exceeding 3.5 kg) in the past 3 months.
• Inability to provide written informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07541794 · IRB00012696

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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