This study employs a randomized controlled trial to test the cognitive enhancing and stress relieving potential of the product Zembrin® in healthy adults when consumed over an 8 week period.
The aim of the proposed randomized, double-blind, placebo-controlled, parallel groups study is to assess the effects of 8 weeks supplementation with Zembrin®, in 30-50 year old healthy adults, on cognitive function, mood, psychological and physiological stress responses during a laboratory stressor, fatigue and sleep quality. The trial will utilize the COMPASS cognitive assessment system and a range of mood measures and will employ the Observed Multitasking Stressor (OMS), with psychological state and physiological responses assessed before and after, and cognitive function assessed during, the stressor. The cognitive/mood assessments will take place prior to (Day -1 with respect to treatment) and after 8 weeks supplementation with Zembrin. An interim mood/fatigue assessment will take place online (Cognimapp) with a baseline measurement collected between the screening visit and Day -1 and post dose measurements collected after 7 and 28 days 1 and 4 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
120
Zembrin® is a proprietary low-alkaloid extract of Sceletium tortuosum, often consumed by healthy humans in order to decrease anxiety and stress and improve cognitive function under stressful situations
Brain Performance and Nutrition Research Centre
Newcastle upon Tyne, Tyne and Wear, United Kingdom
RECRUITINGSubjective stress
This outcome will be assessed via changes on the Perceived Stress Scale (PSS). This is a 10 item scale scored from 0 (NEVER) to 4 (very often) with a higher score indicating greater stress.
Time frame: 56 days
Mental fatigue
This outcome will be assessed via changes on the Multidimensional Fatigue Inventory (MFI-20). This is a 20 item questionnaire scored from 1 (yes, that is true) to 7 (no, that is not true) with higher scores indicating more fatigue.
Time frame: 56 days
Subjective happiness
This outcome will be assessed via changes on the Oxford Happiness Questionnaire (OHQ). This is a 29 item questionnaire scored from 1 (strongly disagree) to 6 (strongly agree) with a higher score indicating greater happiness.
Time frame: 56 days
Subjective alertness
This outcome will be assessed via changes on the Visual Analogue Scale (VAS) for alertness. This VAS is a 100 mm line with 'not alert' and 'alert' anchoring each end of the line. This is scored from mm distance along the line towards 'alert'; with a higher score indicating greater alertness.
Time frame: 56 days
Physical fatigue/ sleep quality
This outcome will be assessed via changes on the Athens Insomnia Scale (within the MFI-20). This is scored as per the MFI detailed in outcome 2 above.
Time frame: 56 days
Cognitive function
This outcome will be assessed via changes on the cognitive task outcomes (measured via COMPASS). COMPASS is a proprietorial software platform for delivering a range of cognitive tasks; assessing domains like memory and attention, with tasks scored for accuracy (% correct) and speed (msec).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 56 days
Physiological induced stress
This outcome will be assessed via changes in heart rate (beats per minute) during the observed multitasking stressor. Higher values indicate greater stress.
Time frame: 56 days
Psychological induced stress
This outcome will be assessed via changes on the State portion Trait Anxiety Inventory (STAI). The state portion of this questionnaire comprises 20 items which is scored from 1 (not at all) to 4 (very much so) with a higher score indicating greater stress.
Time frame: 56 days
Galvanic skin response
This outcome will be assessed via changes in galvanic skin response (micro siemans) during the observed multitasking stressor). Higher values indicate greater stress.
Time frame: 56 days
Salivary cortisol
This outcome will be assessed via changes in salivary cortisol (nmol/L) during the observed multitasking stressor. Higher values indicate greater stress.
Time frame: 56 days
Alpha Amylase
This outcome will be assessed via changes in alpha amylase (nmol/L) during the observed multitasking stressor. Higher values indicate greater stress.
Time frame: 56 days