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

DOUBLE-BLIND RANDOMIZED CLINICAL TRIALS TO SUSTAIN COGNITIVE FUNCTIONING VIA MODULATION OF GUT MICROBIOME AND INFLAMMATION FOR INDIVIDUALS AT RISK OF COGNITIVE DECLINE

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).

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder (MDD)
• Intervention / Treatment: Dietary supplement: Eicosapentaenoic acid (omega-3 fatty acid); Dietary supplement: Soybean oil (Standard treatment)

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung
    • Taichung, Taichung, Taiwan, 404
      • Recruiting
      • Mind Body Interface Research Center (MBI Lab & Care)
      • Contact: Kuan_Pin Su, MD, PhD; Phone Number: 14128 +886 (04) 2205-2121; Email: cobol@cmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eicosapentaenoic Acid (EPA); 3 gram/day	Dietary supplement: Eicosapentaenoic acid (omega-3 fatty acid); 3 grams/day
Placebo Comparator: Placebo; Soy Bean Oil, 3 gram/day	Dietary supplement: Soybean oil (Standard treatment); 3g/day of Soybean Oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Weeks 0, 4, 8, 12, 16, 24
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.	Weeks 0, 4, 8, 12, 16, 24
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.	Weeks 0, 4, 8, 12, 16, 24
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.	Weeks 0, 4, 8, 12, 16, 24
Executive Functioning	The Trail Making Test (TMT) evaluates cognitive impairment by measuring the time (in seconds) to complete tasks. Higher scores indicate slower, more impaired performance.	Weeks 0, 4, 12, 24
Executive Functioning	Based on clinical literature, the Reliable Digit Span (RDS)-a raw score sum of the longest string of digits recalled forward and backward-is a common embedded measure of executive functioning and performance validity. Below 7 indicates a need for caution regarding the validity of the patient's cognitive effort or indicates a potential decline in working memory/attention.	Weeks 0, 4, 12, 24
Executive Functioning	The Modified Wisconsin Card Sorting Test (M-WCST) assesses executive functioning, with higher scores indicating greater dysfunction or impairment.	Weeks 0, 4, 12, 24
General Cognitive Ability and Memory & Attention	The 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.	Weeks 0, 4, 12, 24
Processing Speed	Commonly 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.	Weeks 0, 4, 12, 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiome composition	Gut microbiota composition is primarily measured by analyzing microbial DNA extracted from fecal (stool) samples.	Weeks 0 and 24
Fatty Acids Profiles in Blood	Fatty acid (FA) profiles in blood (red blood cells) are primarily measured using gas chromatography (GC).	Weeks 0 and 24

Collaborators and Investigators

• Sponsor: National Science and Technology Council, Taiwan
• Collaborators: University College Cork; IRCCS Centro San Giovanni di Dio Fatebenefratelli

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Fatty Acids; Lipids; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Preparations; Biological Products; Complex Mixtures; Eicosanoids; Fatty Acids, Unsaturated; Plant Oils; Oils; Dietary Fats; Fats; Dietary Fats, Unsaturated; Fish Oils; Fats, Unsaturated; Eicosapentaenoic Acid; Fatty Acids, Omega-3; Soybean Oil
• Other Study ID Numbers: CMUH114-REC3-136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No