About this trial
POWER project is a randomized, controlled, non-profit study with the primary objective of testing the effectiveness of non-pharmacological interventions-such as physical activity, cognitive training, and dietary supplementation-in reducing depressive symptoms and preventing or delaying cognitive impairments that frequently co-occur in individuals with Major Depressive Disorder (MDD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 50-80 years old
Major Depressive Disorder
Absence or mild cognitive impairment
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Soybean oil (Standard treatment)
Dietary supplement3g/day of Soybean Oil
Eicosapentaenoic acid (omega-3 fatty acid)
Dietary supplement3 grams/day
Treatment groups
Trial outcomes
Primary outcomes
Depressive Symptoms
The 17-item version (HAMD-17) is used to quantify the severity of depression. A score of ≥18 shows a significant depression level.
Depressive Symptoms
The GDS-15 (15-item Geriatric Depression Scale), a score of 5 or higher (≥5) indicates the presence of depression, or "clinically relevant" depressive symptoms.
Depressive Symptoms
The 20-item Center for Epidemiological Studies Depression Scale (CES-D) to indicate significant, or "clinical," depressive symptoms is a total score higher than or equal to 16.
Depressive Symptoms
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale with a total score range of 0 to 60, where higher scores indicate more severe depression.
Secondary outcomes
Gut microbiome composition
Gut microbiota composition is primarily measured by analyzing microbial DNA extracted from fecal (stool) samples.
Fatty Acids Profiles in Blood
Fatty acid (FA) profiles in blood (red blood cells) are primarily measured using gas chromatography (GC).
Sponsors and contacts
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National Science and Technology Council, Taiwan
Lead sponsor
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Collaborator
University College Cork
Collaborator