Psychological Effects of 8 Weeks Supplementation With Sceletium Tortuosum Extract

NCT05471804 | Unknown

• 1 other identifier: 61CC1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change; Stress, Psychological

Keywords

Zembrin; Sceletium tortuosum; COMPASS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Mental fatigue

  56 days

• Subjective happiness

  56 days

• Subjective alertness

  56 days

• Physical fatigue/ sleep quality

  56 days

• Cognitive function

  56 days

Study Arms (2)

Placebo control

PLACEBO COMPARATOR

An inert tablet with the same physical appearance as the experimental intervention tablet

Dietary Supplement: Sceletium tortuosum

Zembrin

EXPERIMENTAL

25 mg per day of Sceletium tortuosum extract (Zembrin®)

Dietary Supplement: Sceletium tortuosum

Interventions

Sceletium tortuosum DIETARY_SUPPLEMENT

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

Also known as: Zembrin

Placebo control; Zembrin

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must self-assess themselves as being in good health Aged 30 to 50 years at the time of giving consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• HG&H Pharmaceuticals: collaborator

Study Sites (1)

Brain Performance and Nutrition Research Centre

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Emma Wightman, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Wightman, PhD

CONTACT

+44(0)191 234; emma.l.wightman@northumbria.ac.uk

David Kennedy, Professor

CONTACT

david.kennedy@northumbria.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 25, 2022
• Study Start: May 18, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)