Cognitive FunctionNCT02763514
The Effects of DHA- and EPA-enriched Oils on Cognitive Function and Mood
A study testing 3 g PronovaPure 150:500 EE EU and 3 g PronovaPure 500:200 EE EU in people with Cognitive Function, 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 cognitive function (episodic memory, attention, working memory, executive function), subjective mood, alertness and mental fatigue after 26 weeks daily supplementation. Read more about this study
- Who is it for?
- Ages 25 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- What is being tested?
- 3 g PronovaPure 150:500 EE EU and 3 g PronovaPure 500:200 EE EU
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 337 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2016to 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 omega-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 Cognitive Function and Mood 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 cognitive function (episodic memory, attention, working memory, executive function), subjective mood, alertness and mental fatigue after 26 weeks daily supplementation.
- Conditions
- Cognitive Function
- Being tested
- 3 g PronovaPure 150:500 EE EU, 3 g PronovaPure 500:200 EE EU, 3 g Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 g PronovaPure 150:500 EE EUDietary supplement
3 g PronovaPure 500:200 EE EUDietary supplement
3 g PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| DHA-enriched oil | Active comparator | 3 g PronovaPure 150:500 EE EU Receives: Dietary Supplement: 3 g PronovaPure 150:500 EE EU |
| EPA-enriched oil | Active comparator | 3 g PronovaPure 500:200 EE EU Receives: Dietary Supplement: 3 g PronovaPure 500:200 EE EU |
| Placebo | Placebo comparator | 3 g Olive oil Receives: Dietary Supplement: 3 g Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodic memory
An overall score for Episodic memory will be derived by calculating the average score from 6 separate standardised task outcomes (Zimmediate word recall accuracy + Zdelayed word recall accuracy + Zword recognition accuracy + Zpicture recognition accuracy - Zimmediate word recall errors - Zdelayed word recall errors)/6
Measured: 26 weeks
Subjective fatigue
Subjective fatigue will be derived from the Fatigue subscale of the Profile of Mood States questionnaire
Measured: 26 weeks
Secondary outcomes (15)
Subjective overall mood disturbance
Subjective overall mood disturbance is derived from the overall score of the Profile of Mood States questionnaire
Measured: 26 weeks
Subjective vigour
Subjective vigour will be derived from the Vigour subscale of the Profile of Mood States questionnaire
Measured: 26 weeks
Subjective confusion
Subjective confusion will be derived from the Confusion subscale of the Profile of Mood States questionnaire
Measured: 26 weeks
Subjective anger
Subjective anger will be derived from the Anger subscale of the Profile of Mood States questionnaire
Measured: 26 weeks
Subjective tension
Subjective tension will be derived from the Tension subscale of the Profile of Mood States questionnaire
Measured: 26 weeks
Subjective alertness
Subjective alertness will be derived from an Alertness visual analogue scale presented following cognitive task performance
Measured: 26 weeks
Subjective mental fatigue
Subjective mental fatigue will be derived from a Mental Fatigue visual analogue scale presented following cognitive task performance
Measured: 26 weeks
Numeric Working memory
Reaction time (ms)
Measured: 26 weeks
Numeric Working memory
Accuracy (%)
Measured: 26 weeks
Simple reaction time
Measured: 26 weeks
Stroop task
Reaction time (ms)
Measured: 26 weeks
Stroop task
Accuracy (%)
Measured: 26 weeks
Rapid visual information processing
Reaction time (ms)
Measured: 26 weeks
Rapid visual information processing
Accuracy (%)
Measured: 26 weeks
Verbal fluency
Number correct
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startOct 2016
- 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 Cognitive FunctionStudies 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
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Pronova BioPharma
- Responsible party
- Principal investigator, Philippa Jackson, Northumbria University
- Investigators
- Philippa Jackson, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763514
- Sponsor's protocol ID
- 44N3
- Status last verified
- Jan 2019
- First submitted
- 20 Apr 2016
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- 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 Cognitive Function and Mood in Healthy Adults
- ClinicalTrials.gov ID
- NCT02763514
- Acronym / sponsor ID
- 44N3
- Conditions
- Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Pronova BioPharma
- Study start
- Oct 2016 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 5 May 2016 (estimated)
- 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 cognitive function (episodic memory, attention, working memory, executive function), subjective mood, alertness and mental fatigue after 26 weeks daily 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 |
|---|---|---|
| DHA-enriched oil | Active comparator | Dietary Supplement: 3 g PronovaPure 150:500 EE EU3 g PronovaPure 150:500 EE EU |
| EPA-enriched oil | Active comparator | Dietary Supplement: 3 g PronovaPure 500:200 EE EU3 g PronovaPure 500:200 EE EU |
| Placebo | Placebo comparator | Dietary Supplement: 3 g Placebo3 g Olive oil |
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 omega-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 |
|---|---|---|
| 3 g PronovaPure 150:500 EE EU | Dietary supplement | DHA-enriched oil |
| 3 g PronovaPure 500:200 EE EU | Dietary supplement | EPA-enriched oil |
| 3 g Placebo | Dietary supplement | Placebo |
Primary outcome
Episodic memory
Time frame: 26 weeks
An overall score for Episodic memory will be derived by calculating the average score from 6 separate standardised task outcomes (Zimmediate word recall accuracy + Zdelayed word recall accuracy + Zword recognition accuracy + Zpicture recognition accuracy - Zimmediate word recall errors - Zdelayed word recall errors)/6
Subjective fatigue
Time frame: 26 weeks
Subjective fatigue will be derived from the Fatigue subscale of the Profile of Mood States questionnaire
15 secondary outcomes
Subjective overall mood disturbance
Time frame: 26 weeks
Subjective vigour
Time frame: 26 weeks
Subjective confusion
Time frame: 26 weeks
Subjective anger
Time frame: 26 weeks
Subjective tension
Time frame: 26 weeks
Subjective alertness
Time frame: 26 weeks
Subjective mental fatigue
Time frame: 26 weeks
Numeric Working memory
Time frame: 26 weeks
Numeric Working memory
Time frame: 26 weeks
Simple reaction time
Time frame: 26 weeks
Stroop task
Time frame: 26 weeks
Stroop task
Time frame: 26 weeks
Rapid visual information processing
Time frame: 26 weeks
Rapid visual information processing
Time frame: 26 weeks
Verbal fluency
Time frame: 26 weeks
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.
Philippa Jackson, PhD principal investigator
Northumbria 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 3 g PronovaPure 150:500 EE EU and 3 g PronovaPure 500:200 EE EU in people with Cognitive Function, 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?
Episodic memory (time frame: 26 weeks). 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 NCT02763514, 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.