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Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice

Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice (POWER)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07462013
Acronym
POWER
Enrollment
120
Registered
2026-03-10
Start date
2025-10-01
Completion date
2028-09-01
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder (MDD)

Brief summary

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).

Interventions

3g/day of Soybean Oil

3 grams/day

Sponsors

National Science and Technology Council, Taiwan
Lead SponsorOTHER_GOV
IRCCS Centro San Giovanni di Dio Fatebenefratelli
CollaboratorOTHER
University College Cork
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

Participants will be randomly assigned to one of two groups: 1) soybean oil placebo, 2) omega-3 PUFA supplementation (3g/day of eicosapentaenoic acid (EPA)).

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Aged 50-80 years old * Major Depressive Disorder * Absence or mild cognitive impairment

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Depressive SymptomsWeeks 0, 4, 8, 12, 16, 24The 17-item version (HAMD-17) is used to quantify the severity of depression. A score of ≥18 shows a significant depression level.
Executive FunctioningWeeks 0, 4, 12, 24The Trail Making Test (TMT) evaluates cognitive impairment by measuring the time (in seconds) to complete tasks. Higher scores indicate slower, more impaired performance.
General Cognitive Ability and Memory & AttentionWeeks 0, 4, 12, 24The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) uses age-corrected index scores (Mean=100, SD=15) to identify cognitive impairment. Cutoff points for identifying impairment are set at 1 or 1.5 standard deviations (SD) below the mean.
Processing SpeedWeeks 0, 4, 12, 24Commonly used cut-off points for identifying cognitive impairment using the Digit Symbol Substitution Test (DSST) often fall within the range of lower than or equal to 25-35 points.

Secondary

MeasureTime frameDescription
Gut microbiome compositionWeeks 0 and 24Gut microbiota composition is primarily measured by analyzing microbial DNA extracted from fecal (stool) samples.
Fatty Acids Profiles in BloodWeeks 0 and 24Fatty acid (FA) profiles in blood (red blood cells) are primarily measured using gas chromatography (GC).

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026