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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05757050
• Other study ID #: 5'000'750-1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: July 21, 2023

Study information

• Verified date: March 2023
• Source: A. Vogel AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 36
• Est. completion date: July 21, 2023
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18-75

Exclusion Criteria:

• • If participant scores less 12, or less, on the Perceived Stress Scale

• Have any pre-existing medical condition/illness which will impact taking part in the study

• NOTE: the explicit exceptions to this are controlled hyper/hypothyroidism, hay fever, high cholesterol and reflux-related conditions

• Are currently taking prescription medications

*NOTE: the explicit exceptions to this are contraceptive treatments for female participants, thyroid medications, topical skin treatments and those medications used in the treatment of high cholesterol and reflux-related conditions; and those taken 'as needed' in the treatment of asthma and hay fever

• Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg). NOTE: that we must measure this in the lab using our blood pressure monitors and can only use our measurements to assess eligibility rather than home or GP readings

• Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2

• Are pregnant, seeking to become pregnant or lactating

• Have learning and/or behavioural difficulties such as dyslexia or ADHD

• Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)

• Smoke tobacco or vape nicotine or use nicotine replacement products (if you have recently quit smoking or using replacements you must have stopped using them altogether for a period of 3 months before participating in this study)

• Have excessive caffeine intake (>500 mg per day). Note: This will be calculated at screening but feel free to query this with the researcher prior to attendance

• Have relevant food allergies/ intolerances/ sensitivities (Please discuss with researcher prior to attendance if you are unsure of relevance)

• Have taken antibiotics within the past 4 weeks

• Have taken dietary supplements e.g. vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4-week supplement washout prior to participating and for the duration of the study on the proviso that the supplements are taken are out of choice and are not medically prescribed or advised). Existing and consistent use of vitamin D supplements and protein shakes are permitted

• Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)

• Are unable to complete all of the study assessments

• Are currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks

• Have been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months

• Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months, including a medical diagnosis of anxiety or depression.

• Suffers from frequent migraines that require medication (more than or equal to 1 per month)

• Have oral disease

• Have any known active infections

• Does not have a bank account (required for payment)

• Are non-compliant with regards treatment consumption

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Re-Focus "Verum" Tablets
The active intervention contains Scutellaria baicalensis (400 mg) and Crataegus (40 mg) and is in the form of a chewable tablet with a blood-orange flavour
• Re-Focus "Placebo" Tablets
The placebo will be a matched control.

Locations

Country	Name	City	State
United Kingdom	Northumbria University	Newcastle Upon Tyne	Tyne & Wear

Sponsors (2)

Lead Sponsor	Collaborator
A. Vogel AG	University of Newcastle Upon-Tyne

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cognitive function - Cognitive domain factor score	Speed of attention, accuracy of attention, speed of memory, accuracy of working memory, and accuracy of episodic memory measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University)	Prior to (baseline) and chronic (2 weeks) of intervention
Primary	Change in Cognitive function - Cognitive domain factor score	Speed of attention, accuracy of attention, speed of memory, accuracy of working memory, and accuracy of episodic memory measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University)	Prior to (baseline) and following acute (60 minutes post-dose) of intervention
Secondary	Profile of Mood States (POMS)	35-item measure, summed to create measures of vigour, tension, fatigue, depression, confusion, anger, friendliness and total mood disturbance	Prior to (baseline) and following 1 and 2 weeks of intervention
Secondary	Perceived Stress Scale (PSS)	10-item measure, summed to create a single value with higher scores indicating higher levels of stress	Prior to (baseline) and following 1 and 2 weeks of intervention
Secondary	State-Trait Anxiety Inventory (STAI) - Trait subscale	20 item measure, summed to create a measure of trait anxiety	Prior to (baseline) and following 1 and 2 weeks of intervention
Secondary	World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)	World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)	Prior to (baseline) and following 1 and 2 weeks of intervention
Secondary	Subjective sleep continuity	Perceived sleep continuity as assessed by subjective sleep diary (measuring: Sleep latency, time in bed, number of awakenings, wake after sleep onset, total sleep time, sleep efficiency, nocturnal physical tension, nocturnal psychological tension, sleep enjoyment and feelings of restedness)	Prior to (baseline) and following 1 and 2 weeks of intervention
Secondary	Subjective sleep via Patient-Reported Outcome Measurement, Information System Sleep Disturbance scale (PROMIS-SD)	8-item measure, summed to create a single value with higher scores indicating higher levels of sleep disturbance	Prior to (baseline) and following 1 and 2 weeks of intervention
Secondary	Depression, Anxiety and Stress scale (DASS-21)	21 item measure, summed to create 3 component scores; depression, anxiety and stress.	Prior to (baseline) and following 1 and 2 weeks of intervention
Secondary	Visual Analogue Mood Scales (VAMS)	18 visual analogue scales scored along a 100 mm line, combined to give an average score on 3 factors: Alertness, Tranquillity and Stress	Prior to (baseline) and following 1 and 2 weeks of intervention
Secondary	Visual Analogue Scales (VAS)	Visual analogue scales scored along a 100 mm line, including 'relaxed', 'stress', 'anxious', 'calm'	Prior to (baseline) and following 1 and 2 weeks of intervention
Secondary	Cognitive function - Individual cognitive task score	Individual tasks include the following: Immediate word recall, numeric working memory, choice reaction time, Corsi blocks, Peg and ball, delayed word recall, delayed word recognition, delayed name to face recall, delayed picture recognition measured by COMPASS, Northumbria University	Prior to (baseline) and following acute (60 minutes post-dose) and chronic (2 weeks) intervention
Secondary	Cognitive function - Cognitively demanding tasks	Cognitive function and mental fatigue during extended performance of cognitively demanding tasks (Cognitive Demand Battery, comprising serial 3s subtractions, serial 7s subtractions, rapid visual information processing task, and mental fatigue scale, repeated 3 times). Measured COMPASS, Northumbria University	Prior to (baseline) and following acute (60 minutes post-dose) and chronic (2 weeks) intervention
Secondary	Subjective stress reactivity - State-Trait Anxiety Inventory (STAI), State subscale	20 item measure, summed to create a measure of subjective state anxiety. Measured as response to psychological stressor	Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Secondary	Physiological stress reactivity - cortisol and a-amylase	Measuring salivary cortisol and a-amylase to determine response to psychological stressor	Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Secondary	Physiological stress reactivity - Galvanised skin response (GSR)	Measuring galvanised skin response to psychological stressor	Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Secondary	Physiological stress reactivity - Heart rate (HR)	Measuring heart rate in response to psychological stressor	Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Secondary	Cognitive function during psychological stressor	Individual tasks include the following: serial 3s subtractions, serial 7s subtractions, serial 17s subtractions and a tracking task during psychological stressor	Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Secondary	Visual Analogue Mood Scales (VAMS)	18 visual analogue scales scored along a 100 mm line, combined to give an average score on 3 factors: Alertness, Tranquillity and Stress	Prior to (baseline) and following one dose (acute) at 60 minutes post-dose
Secondary	Visual Analogue Scales (VAS)	Visual analogue scales scored along a 100 mm line, including 'relaxed' 'stress' 'anxious' 'calm'	Prior to (baseline) and following one dose (acute) at 60 minutes post-dose