Mental Balance Study

Mental Health Wellness 1 Clinical Trial

Official title: Evaluating the Effects of the Supplement ReFocus Tablets on Stress, Cognitive Function, Sleep and Wellbeing Following 14 Days Consumption in Healthy Volunteers Reporting Subjective Stress: A Randomised, Double-blind, Placebo Controlled, Crossover Trial

Status Enrolling by invitation

Clinical Trial Summary

The proposed design is a randomised, double-blind, controlled, crossover intervention assessing the effects of an active intervention, containing Scutellaria baicalensis and Crataegus, versus placebo, on stress, cognition, sleep and wellbeing in healthy human volunteers. Outcome measures will be assessed acutely on day 1 and following 14 days of supplement consumption. Some interim outcome measures will also be assessed throughout the supplementation period to monitor sub-chronic changes

Clinical Trial Description

Participants will attend the laboratory on 5 occasions. The first visit will take place on day -2 (this is a minimum period and can take place a maximum of 14 days prior to the baseline lab visit. A training refresher will take place if 14 days is exceeded) and represents an in-person screening and training visit. (This takes place following an earlier telephone pre-screen where participants will confirm that they meet the study inclusion criteria, and not any of the exclusion criteria (performed separately, this refines the lab-based screening/training visit).) Here participants will provide written, informed consent, complete demographic and anthropometric measurements (BMI & WHR) and be trained on the COMPASS cognitive tasks and study questionnaires.

If progressed through training/screening, participants will then return to the lab, on day 1, to complete their baseline lab visit for arm 1. This will take place at approximately 10:00 am, with participants having consumed their normal breakfast no later than 8:30 am that morning. Participants will first complete the PROM questionnaires and a baseline GSR reading (including a day-baseline saliva sample) will also be taken during this time. For the next 50 minutes, participants will complete the pre-dose COMPASS cognitive task battery and, after a short break, participants will complete the pre-dose OMS. At approximately 11:50 am, participants will consume their full daily treatment dose (2 tablets) along with a standardised lunch of a white bread cheese sandwich, packet of ready salted crisps, and a custard pot. After an hour-long 'absorption' period, participants will complete the post-dose COMPASS cognitive tasks and OMS and the testing day will be completed at approximately 2:30 pm.

Before leaving the lab, participants will be provided with their 14 (+/- the additional doses required for compliance and in case of delayed return for the chronic visit) days-worth of treatment, alongside a treatment diary to note down the time of treatment consumption each day. (The number of returned tablets on day 15, alongside reference to this treatment diary, will serve as the study compliance measures.) Participants will be advised to adhere to the following dosing regimen for each day going forward; 1 tablet in the morning, 1 in the evening, to be consumed 1 hour away from meals. On day 7 (+/- 2 days), participants will complete the PROM questionnaires, via survey, at home.

Participants will return to the lab on day 15 (+/- 2 days), following 14 full days of treatment, for the chronic lab visit for arm 1, and repeat the same procedure as day 1. A minimum 14-day washout period (with a maximum of 28 days) will then commence.

On day 30, participants will return to the lab for the baseline visit for arm 2 and repeat the same procedure as the acute arm 1 for visit. During the interim period, treatment will be consumed in the same way and, half-way through the dosing period (day 36 (+/- 2 days)) participants will complete the PROM questionnaires, via survey, at home.

On day 44 (+/- 2 days) participants will return to the lab for the chronic lab visit for arm 2, their final visit, which will be identical to the arm 1 chronic lab visit, with the exception that participants will be debriefed at the end of their visit and participant payment arranged. Here, participants will also be asked which treatment order they believed themselves to be on.

Please see figure 3 for the overall trial diagram and figure 4 for the procedure within the acute and chronic testing sessions. ;

Related Conditions & MeSH terms

• Mental Health Wellness 1
• Occupational Stress
• Work Related Stress

• NCT number: NCT05757050
• Study type: Interventional
• Source: A. Vogel AG
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 13, 2023
• Completion date: July 21, 2023