ETASCAN Project: ETAS Project 2

Официальное название

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

Обзор

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

Подробное описание

This 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. Sixty participants will be randomised to Intervention or Placebo groups where they will be consuming capsules containing 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 language/memory; affective measures of depression and anxiety symptomatology; and sleep; gastrointestinal symptomatology ; systolic and diastolic blood pressure, as well as height, weight, hip and waist circumference. Brain structure, function, and chemistry at both time points. Furthermore, random selection of participants (n=30, 15 in each group) will receive at home stool sample collection kits and microbiome diversity and compoisiton will be analysed at two time points.

Вмешательства

• Пищевая добавка ETAS®
  1500mg ETAS®
• Пищевая добавка Placebo
  Matched placebo capsule

Первичные конечные точки

• Montreal Cognitive Assessment (MoCA) score [Срок оценки: From baseline (pre intervention) to week 12 (post intervention)]
• fMRI [Срок оценки: From baseline (pre intervention) to week 12 (post intervention)]
• MRS [Срок оценки: From baseline (pre intervention) to week 12 (post intervention)]

Вторичные конечные точки (11)

• Pittsburgh Sleep Quality Index Scores [Срок оценки: From baseline (pre intervention) to week 12 (post intervention)]
• Immediate Word Recall from the Rey Auditory Verbal Learning Task [Срок оценки: From baseline (pre intervention) to week 12 (post intervention)]
• Delayed Word Recall from the Rey Auditory Verbal Learning Task [Срок оценки: From baseline (pre intervention) to week 12 (post intervention)]
• Gastrointestinal Symptom Rating Scale Scores [Срок оценки: From baseline (pre intervention) to week 12 (post intervention)]
• Brain structure [Срок оценки: From baseline (pre intervention) to week 12 (post intervention)]
• Patient Healthcare Questionnaire 8 (PHQ-8) [Срок оценки: From baseline (pre intervention) to week 12 (post intervention)]
• Generalised anxiety disorder 7 item scale (GAD-7) [Срок оценки: From baseline (pre intervention) to week 12 (post intervention)]
• EPIC Norfolk Food Frequency Questionnaire (FFQ) [Срок оценки: From baseline (pre intervention) to week 12 (post intervention)]
• Blood Pressure [Срок оценки: From baseline (pre intervention) to week 12 (post intervention)]
• Hip and waist circumference [Срок оценки: From baseline (pre intervention) to week 12 (post intervention)]
• Body mass index [Срок оценки: From baseline (pre intervention) to week 12 (post intervention)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Smoking
• Having food allergies
• Following restrictive and/or unbalanced diets (Appendix 6: Are you vegetarian or vegan? Yes / No; Are you currently on a weight-reducing or other special diet? Yes/No If 'Yes', please give details.)
• 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 hypertension or thrombosis related disorders or suffer from thyroid disease
• 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 a significant gastrointestinal (GI) condition affecting absorption including (but not limited to) inflammatory bowel disease; total colectomy or bariatric surgery; irritable bowel disease; end stage renal disease; active cancer, or treatment for any cancer, in last 3 years
• History of claustrophobia
• Fitted with a pacemaker or artificial heart valve
• Have active implants, such as cochlear, ocular, or penile implant
• Experience of metal fragments e.g. shrapnel in your eyes or any other part of your body
• Drug infusion pump installed
• Have any surgically implanted metal in any part of your body, other than dental fillings and crowns (e.g. joint replacement or bone re-construction)
• Have had any surgery that might have involved metal implants
• Current or historical experience of epilepsy
• Have stimulators for nerves, brain or bone installed
• Have an intrauterine contraceptive device installed (IUD)
• Wear transdermal patches containing metal
• Wear a filling, crown, dental post (entirely within the tooth) associated with root canal treatment, retainer, bridge or braces
• For scanning, would need to remove coloured contact lenses, nail polish and makeup.
• Hearing aid wearer
• Body piercings that you cannot or will not remove for the scanning session
• Have tattoos or permanent makeup

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Великобритания · 1 центр

• University of Reading, School of Psychology and Clinical Languages — Reading

Идентификаторы

NCT: NCT07550140 · 2025-229-PH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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