Mental Balance Study

NCT05757050 | Completed

• 1 other identifier: 5'000'750-1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Mental Health Wellness 1; Work Related Stress

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (18)

• Profile of Mood States (POMS)

  Prior to (baseline) and following 1 and 2 weeks of intervention

• Perceived Stress Scale (PSS)

  Prior to (baseline) and following 1 and 2 weeks of intervention

• State-Trait Anxiety Inventory (STAI) - Trait subscale

  Prior to (baseline) and following 1 and 2 weeks of intervention

• World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)

  Prior to (baseline) and following 1 and 2 weeks of intervention

• Subjective sleep continuity

  Prior to (baseline) and following 1 and 2 weeks of intervention

Study Arms (2)

Re-Focus Tablets "Verum"

EXPERIMENTAL

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

Dietary Supplement: Re-Focus "Verum" Tablets; Dietary Supplement: Re-Focus "Placebo" Tablets

Re-Focus Tablets "Placebo"

PLACEBO COMPARATOR

The placebo will be a matched control

Dietary Supplement: Re-Focus "Verum" Tablets; Dietary Supplement: Re-Focus "Placebo" Tablets

Interventions

Re-Focus "Verum" Tablets DIETARY_SUPPLEMENT

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

Also known as: Verum

Re-Focus Tablets "Placebo"; Re-Focus Tablets "Verum"

Re-Focus "Placebo" Tablets DIETARY_SUPPLEMENT

The placebo will be a matched control.

Also known as: Placebo

Re-Focus Tablets "Placebo"; Re-Focus Tablets "Verum"

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• A. Vogel AG: lead
• University of Newcastle Upon-Tyne: collaborator

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne & Wear, NE1 8ST, United Kingdom

Location

Related Publications (1)

• Dodd F, Weishaupt R, Katumba PKM, Elcoate R, Wightman E. Effects of a Scutellaria baicalensis/Crataegus laevigata, magnesium and chromium supplement on stressed individuals: A randomised, double-blind, placebo-controlled, crossover trial. J Psychopharmacol. 2025 Dec;39(12):1420-1436. doi: 10.1177/02698811251381261. Epub 2025 Nov 5.

  PMID: 41194549 DERIVED

MeSH Terms

Conditions

Occupational Stress

Interventions

calcium D-pantothenate, L-cysteine drug combination

Condition Hierarchy (Ancestors)

Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 7, 2023
• Study Start: March 9, 2023
• Primary Completion: August 21, 2023
• Study Completion: September 21, 2023
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)