Mental Balance Study (NCT05757050) | Clinical Trial Compass
CompletedNot Applicable
Mental Balance Study
United Kingdom36 participantsStarted 2023-03-09
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 participatin…
What they're measuring
1
Change in Cognitive function - Cognitive domain factor score
Timeframe: Prior to (baseline) and chronic (2 weeks) of intervention
2
Change in Cognitive function - Cognitive domain factor score
Timeframe: Prior to (baseline) and following acute (60 minutes post-dose) of intervention