Healthy AdultsOSADMSNCT07157241
Effect of Omega-3 Supplements on Stress, Anxiety, Depression, Memory and Sleep Quality Among Saudis
A study testing Intervention in people with Healthy Adults and Anxiety, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults, Anxiety, Depression
- What is being tested?
- Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 27 Feb 2022to 16 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- high psychological distress did not take any omega-3 supplements for the last 6 month
- -
Who cannot join
- younger than 18 pregnant breastfeeding anyone with supplements and chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Omega-3 Supplements on Stress, Anxiety, Depression, Memory and Sleep Quality Among Saudi Adults: A Double-Blind Placebo Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
Psychological stress, anxiety, depression, memory difficulties, and poor sleep quality are common issues that affect many adults and can lower overall health and quality of life. Although pharmaceutical treatments exist, they often come with side effects and may not work for everyone. Nutritional approaches, such as omega-3 polyunsaturated fatty acid (PUFA) supplementation, have gained interest due to their possible neuroprotective, anti-inflammatory, and mood-regulating effects.
This study investigated the impact of daily omega-3 supplementation (500 mg EPA + 250 mg DHA) for three months compared with placebo in Saudi adults with high levels of stress and anxiety. Validated tools - including the Perceived Stress Scale (PSS), Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Everyday Memory Questionnaire (EMQ), and sleep quality scales (PSQI, ESS) - were used to assess changes before and after the intervention.
The trial used a randomized, double-blind, placebo-controlled design. Adherence was monitored through daily communication and monthly capsule counts. Results indicated significant improvements in stress, anxiety, depression, memory, and sleep quality for participants who received omega-3 compared with those who received placebo. Statistical analyses showed strong effect sizes and predictive relationships between baseline measures and outcomes.
This research highlights the potential role of omega-3 supplementation as a supportive strategy for mental wellbeing and sleep improvement. Further studies are needed to explore individual responses and underlying biological mechanisms.
- Conditions
- Healthy Adults, Anxiety, Depression, Sleep Quality, Everyday Memory, Psychological Distress
- Being tested
- Intervention, Control group (placebo)
- Keywords
- omega-3, stress, anxiety, mental distress, Psychological Distress, healthy adults, depression, sleep Quality, Everyday Memory, Saudi Arabia
- Medical subject headings
- Anxiety Disorders, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDietary supplement
omega-3 capsules with a concentration of 1000 mg/day for three months (NOW Foods- Ultra omega-3 500 EPA/250 DHA).
Control group (placebo)Dietary supplement
corn oil capsule /day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | corn oil 400 mg capsule a day for for three months Receives: 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). Receives: Dietary Supplement: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Change in Perceived Stress Perceived Stress Scale (0-40, higher = more stress). Self-reported at baseline and 3 months.
- Change in Anxiety Level Generalized Anxiety Disorder-7 (0-21, higher = more anxiety). Self-reported at baseline and 3 months.
- Change in Depression Level Patient Health Questionnaire-9 (0-27, higher = more depression). Self-reported at baseline and 3 months.
- Change in Sleep Quality Pittsburgh Sleep Quality Index (0-21, higher = poorer sleep quality). Self-reported at baseline and 3 months.
- Change in Daytime Sleepiness Epworth Sleepiness Scale (0-24, higher = more sleepiness). Self-reported at baseline and 3 months.
- Change in Everyday Memory Failures Everyday Memory Questionnaire (0-25, higher = more frequent memory failures). Self-reported at baseline and 3 months.
Measured: Baseline and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start27 Feb 2022
- Primary completion12 Feb 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wedad Azhar, Umm Al-Qura University
- Investigators
- Alaa Qadhi, Ph.D, Study director, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157241
- Sponsor's protocol ID
- HAPO-02-K-012-2021-11-832
- Other IDs
- UmmAlQuraU
- Acronym
- OSADMS
- Status last verified
- Aug 2025
- First submitted
- 11 Jul 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share IPD to protect participant confidentiality. Study results are published in summary form only.
Publications
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.
PubMed 41461240
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omega-3 Supplements on Stress, Anxiety, Depression, Memory and Sleep Quality Among Saudi Adults: A Double-Blind Placebo Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07157241
- Acronym / sponsor ID
- OSADMS / HAPO-02-K-012-2021-11-832
- Conditions
- Healthy Adults, Anxiety, Depression, Sleep Quality, Everyday Memory, Psychological Distress
- Keywords
- omega-3, stress, anxiety, mental distress, Psychological Distress, healthy adults, depression, sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 27 Feb 2022 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Psychological stress, anxiety, depression, memory difficulties, and poor sleep quality are common issues that affect many adults and can lower overall health and quality of life. Although pharmaceutical treatments exist, they often come with side effects and may not work for everyone. Nutritional approaches, such as omega-3 polyunsaturated fatty acid (PUFA) supplementation, have gained interest due to their possible neuroprotective, anti-inflammatory, and mood-regulating effects.
This study investigated the impact of daily omega-3 supplementation (500 mg EPA + 250 mg DHA) for three months compared with placebo in Saudi adults with high levels of stress and anxiety. Validated tools - including the Perceived Stress Scale (PSS), Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Everyday Memory Questionnaire (EMQ), and sleep quality scales (PSQI, ESS) - were used to assess changes before and after the intervention.
The trial used a randomized, double-blind, placebo-controlled design. Adherence was monitored through daily communication and monthly capsule counts. Results indicated significant improvements in stress, anxiety, depression, memory, and sleep quality for participants who received omega-3 compared with those who received placebo. Statistical analyses showed strong effect sizes and predictive relationships between baseline measures and outcomes.
This research highlights the potential role of omega-3 supplementation as a supportive strategy for mental wellbeing and sleep improvement. Further studies are needed to explore individual responses and underlying biological mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Control group (placebo)corn oil 400 mg capsule a day for for three months |
| intervention group | Experimental | Dietary Supplement: Interventionmega-3 capsules with a concentration of 1000 mg/day for three months (NOW Foods- Ultra omega-3 500 EPA/250 DHA). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- high psychological distress did not take any omega-3 supplements for the last 6 month
- -
Key exclusion criteria (1 listed)
- younger than 18 pregnant breastfeeding anyone with supplements and chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventionomega-3 capsules with a concentration of 1000 mg/day for three months (NOW Foods- Ultra omega-3 500 EPA/250 DHA). | Dietary supplement | intervention group |
| Control group (placebo)corn oil capsule /day for 3 months | Dietary supplement | Control |
Primary outcome
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.
Time frame: Baseline and 3 months after intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Derived from this study: PubMed 41461240Azhar 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.
- Individual participant dataSharing planned: No. There are no plans to share IPD to protect participant confidentiality. Study results are published in summary form only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa Qadhi, Ph.D study director
Umm Al-Qura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Healthy Adults and Anxiety, run by Umm Al-Qura University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline and 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07157241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.