Memory ConsolidationNCT03592251
26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Memory Consolidation in Healthy Adults
A study testing EPA-rich and DHA-rich in people with Memory Consolidation, run by Northumbria University at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3 polyunsaturated fatty acid dietary supplements on overnight verbal and visual memory consolidation as well as morning alertness before and after 26 weeks of supplementation Read more about this study
- Who is it for?
- Ages 25 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory Consolidation
- What is being tested?
- EPA-rich and DHA-rich
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2017to 30 Nov 2018
- 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 25 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 25 to 49 years inclusive
- Males and females
- Self-report of good health
Who cannot join
- English is not first language (some of the cognitive tasks have only been validated in native English speakers)
- Habitual consumption of oily fish exceeds one fish meal per week
- Habitual consumption of n-3 dietary supplements in the previous 6 months
- Habitual use of dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total; some supplements that do not impact upon cognitive function e.g. garlic, protein, calcium are allowed. Please check with the research team if you are unsure)
- Are a smoker or consume any nicotine replacement products (e.g. chewing gum, e-cigarettes)?
- Food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff
Show all 29Show fewer
- Pregnant, trying to get pregnant or breast feeding
- Body Mass Index outside of the range 18-35 kg/m2
- High blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
- Currently taking blood pressure medication
- Currently taking blood thinning medication (e.g. aspirin, warfarin, heparin)
- Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study)
- Have frequent migraines that require medication (more than or equal to 1 per month)
- History or current diagnosis of drug/alcohol abuse
- History of kidney or liver disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalcaemia), that are likely to interfere with metabolism/absorption/secretion of the product under investigation
- History of neurological or psychiatric illness (excluding depressive illness and anxiety)
- History of head trauma
- Sleep disturbances and/or are taking sleep aid medication
- Blood disorders (e.g. anaemia, haemophilia, thrombocytosis)
- Diagnosis of type I or type II diabetes
- Heart disorder, or vascular illness
- Current diagnosis of depression and/or anxiety
- Over- or under-active thyroid
- Chronic gastrointestinal problems (e.g. Inflammatory Bowel Disease, Irritable Bowel Syndrome, celiac disease)
- Any known active infections
- Diagnosed with or may be at risk of having syphilis, hepatitis, the Human T - lymphotropic virus or the Human Immunodeficiency Virus
- Current or past breast cancer diagnosis and/or a mastectomy
- Health condition that would prevent fulfilment of the study requirements
- Currently participating in or in the past 4 weeks participated in other clinical or nutrition intervention studies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: Efficacy Evaluation of 26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Memory Consolidation in Healthy Adults
The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3 polyunsaturated fatty acid dietary supplements on overnight verbal and visual memory consolidation as well as morning alertness before and after 26 weeks of supplementation
- Conditions
- Memory Consolidation
- Being tested
- Olive Oil Placebo, EPA-rich, DHA-rich
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive Oil PlaceboDietary supplement
6 months placebo supplementation
EPA-richDietary supplement
6 months placebo supplementation
DHA-richDietary supplement
6 months placebo supplementation
| Study group | Role | What they receive |
|---|---|---|
| Olive oil Placebo | Placebo comparator | 3 x 1 g capsules daily Placebo: olive oil Receives: Dietary Supplement: EPA-rich; Dietary Supplement: DHA-rich |
| EPA-rich | Active comparator | 3 x 1 g capsules daily containing a SMEDDS formulation of an EPA-enriched oil totalling 900 mg EPA and 360 mg of DHA Receives: Dietary Supplement: Olive Oil Placebo; Dietary Supplement: DHA-rich |
| DHA-Rich | Active comparator | 3 x 1 g capsules daily containing a SMEDDS formulation of an DHA-enriched oil totalling 900 mg DHA and 270 mg of EPA Receives: Dietary Supplement: Olive Oil Placebo; Dietary Supplement: EPA-rich |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerised Location Learning task
Delayed recall accuracy
Measured: 26 months
Verbal Learning task
Delayed recall accuracy
Measured: 26 months
Secondary outcomes (9)
Computerised Location Learning task
Learning index
Measured: 26 months
Verbal Learning task
Learning index
Measured: 26 months
Peg and Ball/Tower of London task
Planning time (ms)
Measured: pre, Mid and post dose measures
Peg and Ball/Tower of London task
Completion time (ms)
Measured: pre, Mid and post dose measures
Peg and Ball/Tower of London task
Errors (number)
Measured: pre, Mid and post dose measures
Simple reaction time task
reaction time speed from a simple reaction task
Measured: 26 months
Digit vigilance task
accuracy (%)
Measured: 26 months
Digit vigilance task
Reaction time (ms)
Measured: 26 months
Subjective Alertness
Subjective ratings of alertness upon waking on a visual analogue scale (0-100 with 100 denoting the most alert the participant has ever felt in their life)
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Aug 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
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 Memory ConsolidationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- BASF
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592251
- Sponsor's protocol ID
- 44N6
- Status last verified
- Jan 2019
- First submitted
- 29 May 2018
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patan MJ, Kennedy DO, Husberg C, Hustvedt SO, Calder PC, Khan J, Forster J, Jackson PA. Supplementation with oil rich in eicosapentaenoic acid, but not in docosahexaenoic acid, improves global cognitive function in healthy, young adults: results from randomized controlled trials. Am J Clin Nutr. 2021 Sep 1;114(3):914-924. doi: 10.1093/ajcn/nqab174.
PubMed 34113957
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of 26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Memory Consolidation in Healthy Adults
- ClinicalTrials.gov ID
- NCT03592251
- Acronym / sponsor ID
- 44N6
- Conditions
- Memory Consolidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- BASF
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 19 Jul 2018 (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.
The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3 polyunsaturated fatty acid dietary supplements on overnight verbal and visual memory consolidation as well as morning alertness before and after 26 weeks of supplementation
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olive oil Placebo | Placebo comparator | Dietary Supplement: EPA-rich, Dietary Supplement: DHA-rich3 x 1 g capsules daily Placebo: olive oil |
| EPA-rich | Active comparator | Dietary Supplement: Olive Oil Placebo, Dietary Supplement: DHA-rich3 x 1 g capsules daily containing a SMEDDS formulation of an EPA-enriched oil totalling 900 mg EPA and 360 mg of DHA |
| DHA-Rich | Active comparator | Dietary Supplement: Olive Oil Placebo, Dietary Supplement: EPA-rich3 x 1 g capsules daily containing a SMEDDS formulation of an DHA-enriched oil totalling 900 mg DHA and 270 mg of EPA |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 25 to 49 years inclusive
- Males and females
- Self-report of good health
Key exclusion criteria (29 listed)
- English is not first language (some of the cognitive tasks have only been validated in native English speakers)
- Habitual consumption of oily fish exceeds one fish meal per week
- Habitual consumption of n-3 dietary supplements in the previous 6 months
- Habitual use of dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total; some supplements that do not impact upon cognitive function e.g. garlic, protein, calcium are allowed. Please check with the research team if you are unsure)
- Are a smoker or consume any nicotine replacement products (e.g. chewing gum, e-cigarettes)?
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 |
|---|---|---|
| Olive Oil Placebo6 months placebo supplementation | Dietary supplement | DHA-Rich, EPA-rich |
| EPA-rich6 months placebo supplementation | Dietary supplement | DHA-Rich, Olive oil Placebo |
| DHA-rich6 months placebo supplementation | Dietary supplement | EPA-rich, Olive oil Placebo |
Primary outcome
Computerised Location Learning task
Time frame: 26 months
Delayed recall accuracy
Verbal Learning task
Time frame: 26 months
Delayed recall accuracy
9 secondary outcomes
Computerised Location Learning task
Time frame: 26 months
Verbal Learning task
Time frame: 26 months
Peg and Ball/Tower of London task
Time frame: pre, Mid and post dose measures
Peg and Ball/Tower of London task
Time frame: pre, Mid and post dose measures
Peg and Ball/Tower of London task
Time frame: pre, Mid and post dose measures
Simple reaction time task
Time frame: 26 months
Digit vigilance task
Time frame: 26 months
Digit vigilance task
Time frame: 26 months
Subjective Alertness
Time frame: 26 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 24 Jan 2019.
- Derived from this study: PubMed 34113957Patan MJ, Kennedy DO, Husberg C, Hustvedt SO, Calder PC, Khan J, Forster J, Jackson PA. Supplementation with oil rich in eicosapentaenoic acid, but not in docosahexaenoic acid, improves global cognitive function in healthy, young adults: results from randomized controlled trials. Am J Clin Nutr. 2021 Sep 1;114(3):914-924. doi: 10.1093/ajcn/nqab174.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPA-rich and DHA-rich in people with Memory Consolidation, run by Northumbria University at 1 site in United Kingdom.
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 3 inclusion and 29 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 24 Jan 2019. 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 United Kingdom. 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?
Computerised Location Learning task (time frame: 26 months). The study lists 2 primary outcomes in all. 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 NCT03592251, 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 24 Jan 2019.