Psychological Effects of 8 Weeks Supplementation With Sceletium Tortuosum Extract (ZEMBRIN)
Primary Purpose
Cognitive Change, Stress, Psychological
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Sceletium tortuosum
Sponsored by
About this trial
This is an interventional basic science trial for Cognitive Change focused on measuring Zembrin, Sceletium tortuosum, COMPASS
Eligibility Criteria
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
Sites / Locations
- Brain Performance and Nutrition Research CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo control
Zembrin
Arm Description
An inert tablet with the same physical appearance as the experimental intervention tablet
25 mg per day of Sceletium tortuosum extract (Zembrin®)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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).
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.
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.
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.
Salivary cortisol
This outcome will be assessed via changes in salivary cortisol (nmol/L) during the observed multitasking stressor. Higher values indicate greater stress.
Alpha Amylase
This outcome will be assessed via changes in alpha amylase (nmol/L) during the observed multitasking stressor. Higher values indicate greater stress.
Full Information
NCT ID
NCT05471804
First Posted
July 13, 2022
Last Updated
July 20, 2022
Sponsor
Northumbria University
Collaborators
HG&H Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT05471804
Brief Title
Psychological Effects of 8 Weeks Supplementation With Sceletium Tortuosum Extract
Acronym
ZEMBRIN
Official Title
Psychological Effects of 8 Weeks Supplementation With Sceletium Tortuosum Extract (Zembrin™): a Randomised, Double Blind, Placebo-controlled, Parallel-groups Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northumbria University
Collaborators
HG&H Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Change, Stress, Psychological
Keywords
Zembrin, Sceletium tortuosum, COMPASS
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo control
Arm Type
Placebo Comparator
Arm Description
An inert tablet with the same physical appearance as the experimental intervention tablet
Arm Title
Zembrin
Arm Type
Experimental
Arm Description
25 mg per day of Sceletium tortuosum extract (Zembrin®)
Intervention Type
Dietary Supplement
Intervention Name(s)
Sceletium tortuosum
Other Intervention Name(s)
Zembrin
Intervention Description
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
Primary Outcome Measure Information:
Title
Subjective stress
Description
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
Secondary Outcome Measure Information:
Title
Mental fatigue
Description
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
Title
Subjective happiness
Description
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
Title
Subjective alertness
Description
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
Title
Physical fatigue/ sleep quality
Description
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
Title
Cognitive function
Description
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).
Time Frame
56 days
Title
Physiological induced stress
Description
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
Title
Psychological induced stress
Description
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
Title
Galvanic skin response
Description
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
Title
Salivary cortisol
Description
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
Title
Alpha Amylase
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Wightman, PhD
Phone
+44(0)191 234
Ext
7252
Email
emma.l.wightman@northumbria.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
David Kennedy, Professor
Email
david.kennedy@northumbria.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Wightman, PhD
Organizational Affiliation
Northumbria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain Performance and Nutrition Research Centre
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE1 8ST
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Wightman, Dr
Phone
0191 227 3725
Email
emma.l.wightman@northumbria.ac.uk
First Name & Middle Initial & Last Name & Degree
David Kennedy, Professor
Phone
0191 243 7720
Email
david.kennedy@northumbria.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The is no plan to share the raw individual participant data with anyone other than the research team here at Northumbria University and the study sponsor.
Learn more about this trial
Psychological Effects of 8 Weeks Supplementation With Sceletium Tortuosum Extract
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