ETASCAN Project: ETAS Project 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorUniversity of Reading
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ETAS®
Dietary supplement1500mg ETAS®
Placebo
Dietary supplementMatched placebo capsule
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ETAS® (1500mg)Experimental treatment 1 intervention
Group B: Matched placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Montreal Cognitive Assessment (MoCA) score
Composite measure of global cognitive function
Time frame
From baseline (pre intervention) to week 12 (post intervention)2
fMRI
Functional brain activity will be analysed during cognitive tasks.
Time frame
From baseline (pre intervention) to week 12 (post intervention)3
MRS
MRS will be used to assess neurochemistry of the medial temporal lobe and medial frontal cortex at rest.
Time frame
From baseline (pre intervention) to week 12 (post intervention)Secondary outcomes
1
Pittsburgh Sleep Quality Index Scores
A validated self-report measure of sleep quality.
Time frame
From baseline (pre intervention) to week 12 (post intervention)2
Immediate Word Recall from the Rey Auditory Verbal Learning Task
Participants will be presented with a sequential list of 15 words, at a rate of 1 word per second. The participant will then have 60s to say out loud as many of these words as possible, with the resulting score recorded as a percentage of accuracy.
Time frame
From baseline (pre intervention) to week 12 (post intervention)3
Delayed Word Recall from the Rey Auditory Verbal Learning Task
After a period of time subject are asked to recall as many words as possible from list A
Time frame
From baseline (pre intervention) to week 12 (post intervention)4
Gastrointestinal Symptom Rating Scale Scores
A validated self-report measure of gastrointestinal symptoms that includes 15-items (combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation)
Time frame
From baseline (pre intervention) to week 12 (post intervention)Other outcomes
1
Telephone Interview for Cognitive Status-40
A questionnaire that assesses cognitive status. It will be used to screen participants.
Time frame
Baseline (pre intervention)2
Gut microbiome diversity
In a random subsample of participants, stool samples will be collected to measure gut microbiome diversity. Indices of alpha and beta diversity will be analysed (16s sequencing).
Time frame
From baseline (pre intervention) to week 12 (post intervention)3
Gut microbiome composition
In a random subsample of participants, stool samples will be collected to measure gut microbiome composition (genus and species) (16s sequencing).
Time frame
From baseline (pre intervention) to week 12 (post intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Reading
Lead sponsor
Amino Up Chemicals Co., Ltd.
Collaborator
Source ClinicalTrials.gov