NCT06790849

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 24, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2025

Completed
Last Updated

November 19, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

January 13, 2025

Last Update Submit

November 18, 2025

Conditions

CognitionAffect (Mental Function)Inflammation

Keywords

ETAS®cognitiondepressionanxietysleepquality of lifeinflammationtau

Outcome Measures

Primary Outcomes (2)

  • Montreal Cognitive Assessment (MoCA) score

    Composite measure of global cognitive function

    From baseline (pre intervention) to week 12 (post intervention)

  • Inflammatory biomarker levels

    IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, CRP levels from plasma

    From baseline (pre intervention) to week 12 (post intervention)

Secondary Outcomes (11)

  • Behaviour Rating Inventory of Executive Function Score

    From baseline (pre intervention) to week 12 (post intervention)

  • Cognitive Failures Questionnaire Score

    From baseline (pre intervention) to week 12 (post intervention)

  • Geriatric Depression Scale scores

    From baseline (pre intervention) to week 12 (post intervention)

  • Geriatric Anxiety Inventory scores

    From baseline (pre intervention) to week 12 (post intervention)

  • Pittsburgh Sleep Quality Index Scores

    From baseline (pre intervention) to week 12 (post intervention)

  • +6 more secondary outcomes

Other Outcomes (1)

  • Telephone Interview for Cognitive Status-40

    Baseline (pre intervention)

Study Arms (3)

Active 1: ETAS® (300mg)

EXPERIMENTAL

Subjects will consume 300mg ETAS®/day (capsule).

Dietary Supplement: Active 1 ETAS®

Active 1: ETAS® (1500mg)

ACTIVE COMPARATOR

Subjects will consume 1500mg ETAS®/day (capsule).

Dietary Supplement: Active 2 ETAS®

Placebo: Matched placebo

PLACEBO COMPARATOR

Subjects will consume a matched placebo capsule.

Dietary Supplement: Placebo

Interventions

Active 1 ETAS®DIETARY_SUPPLEMENT

300 mg ETAS®

Active 1: ETAS® (300mg)
Active 2 ETAS®DIETARY_SUPPLEMENT

1500mg ETAS®

Active 1: ETAS® (1500mg)
PlaceboDIETARY_SUPPLEMENT

Matched placebo capsule

Placebo: Matched placebo

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aging between 60-80 years old
  • Having normal vision and hearing
  • Having a body mass index between 18.5 and 30
  • Having mild to moderate subjective cognitive complaints

You may not qualify if:

  • Smoking
  • Having food allergies or intolerances
  • Following restrictive and/or unbalanced diets
  • Changing dietary intake majorly in past month
  • Being diagnosed with any psychiatric or neurologic conditions (e.g. schizophrenia, depression, dementia) including eating disorders
  • Being diagnosed with any cardiometabolic diseases (including type II diabetes and cardiovascular disease), or suffering from hypertension or thrombosis related disorders or suffer from thyroid disease
  • Being anaemic
  • Currently taking anticoagulants, antiplatelet medication, antidepressants, proton-pump inhibitors
  • Currently consuming prebiotic or probiotic supplements
  • Continuous antibiotic use for \> 3 days within 1 month prior to enrolment
  • Continuous use of weight-loss drug for \> 1 month before screening
  • Having inflammatory bowel disease; coeliac disease; total colectomy or bariatric surgery; irritable bowel disease; end stage renal disease; active cancer, or treatment for any cancer, in last 3 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading, School of Psychology and Clinical Languages

Reading, Berkshire, RG6 6ES, United Kingdom

Location

MeSH Terms

Conditions

InflammationDepressionAnxiety DisordersPick Disease of the Brain

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorMental DisordersFrontotemporal DementiaFrontotemporal Lobar DegenerationDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 24, 2025

Study Start

February 24, 2025

Primary Completion

October 22, 2025

Study Completion

October 22, 2025

Last Updated

November 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)