Psychological Effects of 8 Weeks Supplementation With Sceletium Tortuosum Extract

Stress, Psychological Clinical Trial

— ZEMBRIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05471804
• Other study ID #: 61CC1
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: July 2022
• Source: Northumbria University
• Contact: Emma Wightman, PhD
• Phone: +44(0)191 234
• Email: emma.l.wightman[@]northumbria.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Change
• Stress, Psychological

Intervention

Dietary Supplement:
• Sceletium tortuosum
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

Locations

Country	Name	City	State
United Kingdom	Brain Performance and Nutrition Research Centre	Newcastle Upon Tyne	Tyne And Wear

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	HG&H Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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