ETASCAI Pilot Project

University of Reading

Status: Completed

Conditions: Inflammation; Affect (Mental Function); Cognition

Treatments: Dietary Supplement: Active 2 ETAS®; Dietary Supplement: Placebo; Dietary Supplement: Active 1 ETAS®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06790849

UREC 24_39

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups, including a placebo group

Active 1: ETAS® (300mg)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Active 1 ETAS®

Active 1: ETAS® (1500mg)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Active 2 ETAS®

Placebo: Matched placebo

Placebo Comparator group

Description:

Subjects will consume a matched placebo capsule.

Treatment:

Dietary Supplement: Placebo