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Mental Balance Study

Primary Purpose

Mental Health Wellness 1, Work Related Stress

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Re-Focus "Verum" Tablets
Re-Focus "Placebo" Tablets
Sponsored by
A. Vogel AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Health Wellness 1

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northumbria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Re-Focus Tablets "Verum"

Re-Focus Tablets "Placebo"

Arm Description

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

The placebo will be a matched control

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Profile of Mood States (POMS)
35-item measure, summed to create measures of vigour, tension, fatigue, depression, confusion, anger, friendliness and total mood disturbance
Perceived Stress Scale (PSS)
10-item measure, summed to create a single value with higher scores indicating higher levels of stress
State-Trait Anxiety Inventory (STAI) - Trait subscale
20 item measure, summed to create a measure of trait anxiety
World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)
World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)
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)
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
Depression, Anxiety and Stress scale (DASS-21)
21 item measure, summed to create 3 component scores; depression, anxiety and stress.
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
Visual Analogue Scales (VAS)
Visual analogue scales scored along a 100 mm line, including 'relaxed', 'stress', 'anxious', 'calm'
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
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
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
Physiological stress reactivity - cortisol and a-amylase
Measuring salivary cortisol and a-amylase to determine response to psychological stressor
Physiological stress reactivity - Galvanised skin response (GSR)
Measuring galvanised skin response to psychological stressor
Physiological stress reactivity - Heart rate (HR)
Measuring heart rate in response to psychological stressor
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
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
Visual Analogue Scales (VAS)
Visual analogue scales scored along a 100 mm line, including 'relaxed' 'stress' 'anxious' 'calm'

Full Information

First Posted
February 15, 2023
Last Updated
March 6, 2023
Sponsor
A. Vogel AG
Collaborators
University of Newcastle Upon-Tyne
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1. Study Identification

Unique Protocol Identification Number
NCT05757050
Brief Title
Mental Balance Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 13, 2023 (Anticipated)
Primary Completion Date
June 21, 2023 (Anticipated)
Study Completion Date
July 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
A. Vogel AG
Collaborators
University of Newcastle Upon-Tyne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Wellness 1, Work Related Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Re-Focus Tablets "Verum"
Arm Type
Experimental
Arm Description
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
Arm Title
Re-Focus Tablets "Placebo"
Arm Type
Placebo Comparator
Arm Description
The placebo will be a matched control
Intervention Type
Dietary Supplement
Intervention Name(s)
Re-Focus "Verum" Tablets
Other Intervention Name(s)
Verum
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Re-Focus "Placebo" Tablets
Other Intervention Name(s)
Placebo
Intervention Description
The placebo will be a matched control.
Primary Outcome Measure Information:
Title
Change in Cognitive function - Cognitive domain factor score
Description
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)
Time Frame
Prior to (baseline) and chronic (2 weeks) of intervention
Title
Change in Cognitive function - Cognitive domain factor score
Description
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)
Time Frame
Prior to (baseline) and following acute (60 minutes post-dose) of intervention
Secondary Outcome Measure Information:
Title
Profile of Mood States (POMS)
Description
35-item measure, summed to create measures of vigour, tension, fatigue, depression, confusion, anger, friendliness and total mood disturbance
Time Frame
Prior to (baseline) and following 1 and 2 weeks of intervention
Title
Perceived Stress Scale (PSS)
Description
10-item measure, summed to create a single value with higher scores indicating higher levels of stress
Time Frame
Prior to (baseline) and following 1 and 2 weeks of intervention
Title
State-Trait Anxiety Inventory (STAI) - Trait subscale
Description
20 item measure, summed to create a measure of trait anxiety
Time Frame
Prior to (baseline) and following 1 and 2 weeks of intervention
Title
World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)
Description
World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)
Time Frame
Prior to (baseline) and following 1 and 2 weeks of intervention
Title
Subjective sleep continuity
Description
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)
Time Frame
Prior to (baseline) and following 1 and 2 weeks of intervention
Title
Subjective sleep via Patient-Reported Outcome Measurement, Information System Sleep Disturbance scale (PROMIS-SD)
Description
8-item measure, summed to create a single value with higher scores indicating higher levels of sleep disturbance
Time Frame
Prior to (baseline) and following 1 and 2 weeks of intervention
Title
Depression, Anxiety and Stress scale (DASS-21)
Description
21 item measure, summed to create 3 component scores; depression, anxiety and stress.
Time Frame
Prior to (baseline) and following 1 and 2 weeks of intervention
Title
Visual Analogue Mood Scales (VAMS)
Description
18 visual analogue scales scored along a 100 mm line, combined to give an average score on 3 factors: Alertness, Tranquillity and Stress
Time Frame
Prior to (baseline) and following 1 and 2 weeks of intervention
Title
Visual Analogue Scales (VAS)
Description
Visual analogue scales scored along a 100 mm line, including 'relaxed', 'stress', 'anxious', 'calm'
Time Frame
Prior to (baseline) and following 1 and 2 weeks of intervention
Title
Cognitive function - Individual cognitive task score
Description
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
Time Frame
Prior to (baseline) and following acute (60 minutes post-dose) and chronic (2 weeks) intervention
Title
Cognitive function - Cognitively demanding tasks
Description
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
Time Frame
Prior to (baseline) and following acute (60 minutes post-dose) and chronic (2 weeks) intervention
Title
Subjective stress reactivity - State-Trait Anxiety Inventory (STAI), State subscale
Description
20 item measure, summed to create a measure of subjective state anxiety. Measured as response to psychological stressor
Time Frame
Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Title
Physiological stress reactivity - cortisol and a-amylase
Description
Measuring salivary cortisol and a-amylase to determine response to psychological stressor
Time Frame
Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Title
Physiological stress reactivity - Galvanised skin response (GSR)
Description
Measuring galvanised skin response to psychological stressor
Time Frame
Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Title
Physiological stress reactivity - Heart rate (HR)
Description
Measuring heart rate in response to psychological stressor
Time Frame
Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Title
Cognitive function during psychological stressor
Description
Individual tasks include the following: serial 3s subtractions, serial 7s subtractions, serial 17s subtractions and a tracking task during psychological stressor
Time Frame
Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Title
Visual Analogue Mood Scales (VAMS)
Description
18 visual analogue scales scored along a 100 mm line, combined to give an average score on 3 factors: Alertness, Tranquillity and Stress
Time Frame
Prior to (baseline) and following one dose (acute) at 60 minutes post-dose
Title
Visual Analogue Scales (VAS)
Description
Visual analogue scales scored along a 100 mm line, including 'relaxed' 'stress' 'anxious' 'calm'
Time Frame
Prior to (baseline) and following one dose (acute) at 60 minutes post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Northumbria University
City
Newcastle Upon Tyne
State/Province
Tyne & Wear
ZIP/Postal Code
NE1 8ST
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Pseudonymized and compiled data sheets only

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Mental Balance Study

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