Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-28 @ 8:18 PM
Study NCT ID:
NCT05471804
Status:
UNKNOWN
Last Update Posted:
2022-07-25
First Post:
2022-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological Effects of 8 Weeks Supplementation With Sceletium Tortuosum Extract
Sponsor:
Northumbria University
Organization:
Study Overview
Official Title:
Psychological Effects of 8 Weeks Supplementation With Sceletium Tortuosum Extract (Zembrin™): a Randomised, Double Blind, Placebo-controlled, Parallel-groups Trial
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZEMBRIN
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: