NCT07157241

Brief Summary

This study looked at whether taking omega-3 supplements can help reduce stress, anxiety, depression, and improve memory and sleep quality in Saudi adults who feel highly stressed or anxious. Omega-3 is a healthy fat found in fish oil that may help the brain and mood. A total of 64 adults took part. They were randomly split into two groups. One group took omega-3 capsules (500 mg EPA + 250 mg DHA) every day for three months. The other group took a placebo (an inactive oil). Neither the participants nor the researchers knew who was taking which capsules to keep the study fair. Before and after the three months, all participants completed simple questionnaires about their stress, anxiety, depression, sleep, and everyday memory. The results showed that people who took omega-3 had lower stress, anxiety, and depression scores and reported better sleep quality and memory compared to those who took the placebo. This suggests that taking omega-3 supplements may help improve mental wellbeing and sleep in people with high stress and anxiety.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

July 11, 2025

Last Update Submit

August 28, 2025

Conditions

Keywords

omega-3stressanxietymental distressPsychological Distresshealthy adultsdepressionsleep QualityEveryday MemorySaudi Arabia

Outcome Measures

Primary Outcomes (1)

  • Change from the baseline for the following scales: Perceived Stress General Anxiety Disorder-7 Depression Level measured using PHQ-9 Sleep Quality Daytime sleepiness and sleep disorders Memory failure in everyday life.

    Primary Outcome Measures: 1. Change in Perceived Stress Perceived Stress Scale (0-40, higher = more stress). Self-reported at baseline and 3 months. 2. Change in Anxiety Level Generalized Anxiety Disorder-7 (0-21, higher = more anxiety). Self-reported at baseline and 3 months. 3. Change in Depression Level Patient Health Questionnaire-9 (0-27, higher = more depression). Self-reported at baseline and 3 months. 4. Change in Sleep Quality Pittsburgh Sleep Quality Index (0-21, higher = poorer sleep quality). Self-reported at baseline and 3 months. 5. Change in Daytime Sleepiness Epworth Sleepiness Scale (0-24, higher = more sleepiness). Self-reported at baseline and 3 months. 6. Change in Everyday Memory Failures Everyday Memory Questionnaire (0-25, higher = more frequent memory failures). Self-reported at baseline and 3 months.

    Baseline and 3 months after intervention

Study Arms (2)

Control

PLACEBO COMPARATOR

corn oil 400 mg capsule a day for for three months

Dietary Supplement: Control group (placebo)

intervention group

EXPERIMENTAL

mega-3 capsules with a concentration of 1000 mg/day for three months (NOW Foods- Ultra omega-3 500 EPA/250 DHA).

Dietary Supplement: Intervention

Interventions

InterventionDIETARY_SUPPLEMENT

omega-3 capsules with a concentration of 1000 mg/day for three months (NOW Foods- Ultra omega-3 500 EPA/250 DHA).

intervention group
Control group (placebo)DIETARY_SUPPLEMENT

corn oil capsule /day for 3 months

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • high psychological distress did not take any omega-3 supplements for the last 6 month

You may not qualify if:

  • younger than 18 pregnant breastfeeding anyone with supplements and chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

university of Umm Al-Qura

Mecca, Saudi Arabia

Location

Related Publications (1)

  • Azhar W, Qadhi A, Abusudah W, Ghabashi M, Aljaadi AM, Alyamani R, Awlya O, Almohmadi N, Alsemeri A, Felemban A, Alturki G, Almatrafi L, Zafarani R, Kamfar Y, Azzeh F, Ghafouri K. The effects of Omega-3 supplementation on stress, anxiety, depression, sleep quality, and everyday memory in individuals with psychological distress: A randomized, double-blind, placebo-controlled trial. J Affect Disord. 2026 Apr 15;399:121055. doi: 10.1016/j.jad.2025.121055. Epub 2025 Dec 27.

MeSH Terms

Conditions

Anxiety DisordersDepressionSleep Initiation and Maintenance Disorders

Interventions

MethodsControl Groups

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Investigative TechniquesEpidemiologic Research DesignEpidemiologic MethodsResearch Design

Study Officials

  • Alaa Qadhi, Ph.D

    Umm Al-Qura University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Wedad Azhar, Assistant Professor

Study Record Dates

First Submitted

July 11, 2025

First Posted

September 5, 2025

Study Start

February 27, 2022

Primary Completion

February 12, 2024

Study Completion

August 16, 2024

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

There are no plans to share IPD to protect participant confidentiality. Study results are published in summary form only.

Locations