NCT05471804

Psychological Effects of 8 Weeks Supplementation With Sceletium Tortuosum Extract

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Northumbria University · Academic / Other
• Sex: All
• Age: 30 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cognitive Change
• Stress, Psychological

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-05-18
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2022-07-25
• Last updated: 2022-07-25

Locations

1 site across 1 country: United Kingdom