Psychological Effects of 8 Weeks Supplementation With Sceletium Tortuosum Extract

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Psychological Effects of 8 Weeks Supplementation With Sceletium Tortuosum Extract (Zembrin™): a Randomised, Double Blind, Placebo-controlled, Parallel-groups Trial

Conditions
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Cognitive Change, Stress, Psychological

Intervention / Treatment
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* Dietary Supplement: Sceletium tortuosum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must self-assess themselves as being in good health Aged 30 to 50 years at the time of giving consent Exclusion Criteria: Participants are not eligible to take part if they: Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: the explicit exceptions to this are controlled hay fever, high cholesterol and reflux-related conditions. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance. Are currently taking prescription medications NOTE: the explicit exceptions to this are contraceptive treatments for female participants, those medications used in the treatment of reflux-related conditions; and those taken 'as needed' in the treatment of asthma and hay fever. As above, there may be other instances of medication use which, where no interaction with the active treatments is likely, and which would not be expected to have any impact on brain function, participants may be able to progress to screening. Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg) Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2 Are pregnant, seeking to become pregnant or lactating. Are menopausal/post-menopausal 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 Take any illicit social drugs, including cannabis Have excessive caffeine intake (>500 mg per day) Have relevant food intolerances/ sensitivities Have taken antibiotics within the past 4 weeks Have taken dietary supplements eg. Vitamins, omega 3 fish oils, herbal extracts, cannabadiol 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 they are taken are out of choice and 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 Has 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 Suffers from frequent migraines that require medication (more than or equal to 1 per month) Sleep disorders or are taking sleep aid medication Any known active infections Have oral disease Does not have a bank account (required for payment) Are non-compliant with regards treatment consumption

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo control<br>An inert tablet with the same physical appearance as the experimental intervention tablet | Dietary Supplement: Sceletium tortuosum<br>* 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<br>* Other names: Zembrin;|
| Experimental: Zembrin<br>25 mg per day of Sceletium tortuosum extract (Zembrin®) | Dietary Supplement: Sceletium tortuosum<br>* 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<br>* Other names: Zembrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective 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. | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 56 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zembrin, Sceletium tortuosum, COMPASS