NCT06790849

ETASCAI Pilot Project

The Impact of Chronic Consumption of ETAS® for 12 Weeks on Cognitive, Affective, and Inflammatory Outcomes: A Randomised Parallel Group Placebo-controlled Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Reading · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This pilot study aims to investigate the chronic effects of ETAS® on cognitive, affective and inflammatory outcomes in healthy adults aged 60-80 years with mild to moderate subjective cognitive complaints.

Detailed description

This pilot study will employ a double-blind, randomised, placebo-controlled parallel design to investigate the chronic effects of 12-week-long ETAS® consumption on affective, inflammatory, metabolic, and anthropometric outcomes in healthy older adults with mild to moderate subjective cognitive complaints. Thirty participants will be randomised to Intervention 1, Intervention 2, or Placebo groups where they will be consuming capsules containing 300mg ETAS®, 1500mg ETAS®, or placebo, respectively, for 12-weeks. Outcome measures will be acquired before and after a 12-week chronic supplementation. These will include cognitive measures of overall cognitive functioning, executive function, and cognitive failures; affective measures of depression and anxiety symptomatology; quality of life, and sleep; gastrointestinal symptomatology; inflammatory measures of IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, CRP; systolic and diastolic blood pressure, as well as height, weight, hip and waist circumference. In addition, tau from plasma will be recorded at all timepoints.

Conditions

• Cognition
• Affect (Mental Function)
• Inflammation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Active 1 ETAS®	300 mg ETAS®
DIETARY_SUPPLEMENT	Active 2 ETAS®	1500mg ETAS®
DIETARY_SUPPLEMENT	Placebo	Matched placebo capsule

Timeline

• Start date: 2025-02-24
• Primary completion: 2025-10-22
• Completion: 2025-10-22
• First posted: 2025-01-24
• Last updated: 2025-11-19

Locations

1 site across 1 country: United Kingdom