Cognitive FunctionNCT01185379
The Effects of Efalex Active 50+ on Cognitive Performance, Well-being and Cerebral Hemodynamics in Healthy Older Adults
A study testing Efalex active 50+ and DHA rich fish oil in people with Cognitive Function and Mood, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Dietary intake of omega-3 polyunsaturated fatty acids (n-3 PUFAs) is inversely associated with cognitive decline and dementia (e.g. Kalmijn et al. 2004, Heude et al. 2003, Morris et al. 2005, Dullemeijer et al. 2009). Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Mood, Well-being
- What is being tested?
- Efalex active 50+ and DHA rich fish oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 261 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to Jun 2012
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy
- Aged 50-70 years
- Low consumer of oily fish (≤ 1 portion/month)
- Has not taken vitamin/herbal supplements in the past 3 months
- Has not taken omega-3 supplement (including cod liver oil) in the past 2 years
- Has a good level of written and spoken English
- Has an MMSE score > 24
- Is suffering from a memory complaint (MAC-Q score > 24)
Who cannot join
- BMI > 35
- Smokes more than 15 cigarettes per day
- History of alcohol/drug abuse
- Currently taking statins/antidepressant/blood thinning medication
- Has high blood pressure
- Suffers from migraines/anaemia/heart or lung disorder/diabetes/active infections/jaundice/haemophilia or other clotting disease
Show all 9Show fewer
- Has learning difficulties/dyslexia/colour blindness
- Is HIV positive
- Has hepatitis
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: Investigation of the Effects of Efalex Active 50+ on Cognitive Performance, Well-being and Cerebral Hemodynamics in Healthy Adults Aged 50-70 Years Reporting Subjective Memory Deficits
Dietary intake of omega-3 polyunsaturated fatty acids (n-3 PUFAs) is inversely associated with cognitive decline and dementia (e.g. Kalmijn et al. 2004, Heude et al. 2003, Morris et al. 2005, Dullemeijer et al. 2009). Recently, the effects of supplemental docosahexaenoic acid (DHA) on behavioural outcomes in older adults has been explored, however two trials addressing this issue have published conflicting results regarding the efficacy of DHA supplementation, with one reporting a benefit of treatment on cognitive performance (Yurko-Mauro et al. 2010), while the other did not (Dangour et al. 2010).
One area of research that has yet to be explored in this cohort is the effects of n-3 PUFAs on brain function in physiological terms. It is also possible that n-3 PUFAs, in combination with other compounds, may be more beneficial than treatment with n-3 PUFAs in isolation. The current study will explore several separate hypotheses within the same cohort. These are that Efalex Active 50+ may have a beneficial effect on:
Read more
- Cognitive performance
- Mental fatigue in response to cognitively demanding tasks
- Self-reported mood/well-being
- Task-related cerebral blood flow response
The proposed study therefore has two aims; the primary aim is to evaluate the cognitive and mood/well-being effects of Efalex Active 50+, a dietary supplement containing a number of potentially cognition enhancing components including DHA, phosphatidylserine, vitamin B12, folic acid and Ginkgo biloba, compared with placebo in a sample of older adults aged 50-70 years (Cognitive Study). The second is to evaluate the cerebral haemodynamic effects of the same treatment formulation in a sample drawn from the same population, with the addition of a third DHA-only arm (Hemodynamics Study). The intervention period will be 6 months.
- Conditions
- Cognitive Function, Mood, Well-being, Cerebral Blood Flow
- Being tested
- Efalex active 50+, DHA rich fish oil, Placebo
- Keywords
- Docosahexaenoic acid, omega 3, cerebral blood flow, Near Infrared spectroscopy, cognitive function, mood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efalex active 50+Dietary supplement
4 x 500 mg Efalax Active 50+, to be taken daily for 6 months.
DHA rich fish oilDietary supplement
4 x 500 mg DHA rich tuna oil to be taken daily for 6 months
PlaceboDietary supplement
4 x 500 mg capsules to be taken daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Efalex Active 50+ | Active comparator | Not described Receives: Dietary Supplement: Efalex active 50+ |
| DHA-rich fish oil | Active comparator | Not described Receives: Dietary Supplement: DHA rich fish oil |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance
Performance on a number of tasks assessing cognitive function across domains (attention, memory, executive function) will be measured.
Measured: 6 months
Secondary outcomes (2)
Cerebral Hemodynamics
Cerebral blood flow response to cognitive tasks will be assessed using Near Infrared Spectroscopy (NIRS). General cerebral blood flow will be assessed using Transcranial Doppler (TCD)
Measured: 6 months
Mood/well-being
Mood and well-being will be assessed using a number of measures:
Bond-Lader visual analogue scales, Profile of Mood States (POMS), General Health Questionnaire (GHQ), Pittsburgh Sleep Quality Index (PSQI)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Efamol Ltd
- Responsible party
- Principal investigator, David Kennedy, Northumbria University
- Investigators
- David O Kennedy, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185379
- Sponsor's protocol ID
- 31N1
- Status last verified
- Nov 2010
- First submitted
- 18 Aug 2010
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Efalex Active 50+ on Cognitive Performance, Well-being and Cerebral Hemodynamics in Healthy Adults Aged 50-70 Years Reporting Subjective Memory Deficits
- ClinicalTrials.gov ID
- NCT01185379
- Acronym / sponsor ID
- 31N1
- Conditions
- Cognitive Function, Mood, Well-being, Cerebral Blood Flow
- Keywords
- Docosahexaenoic acid, omega 3, cerebral blood flow, Near Infrared spectroscopy, cognitive function, mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Efamol Ltd
- Study start
- Jul 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Aug 2010 (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.
Dietary intake of omega-3 polyunsaturated fatty acids (n-3 PUFAs) is inversely associated with cognitive decline and dementia (e.g. Kalmijn et al. 2004, Heude et al. 2003, Morris et al. 2005, Dullemeijer et al. 2009). Recently, the effects of supplemental docosahexaenoic acid (DHA) on behavioural outcomes in older adults has been explored, however two trials addressing this issue have published conflicting results regarding the efficacy of DHA supplementation, with one reporting a benefit of treatment on cognitive performance (Yurko-Mauro et al. 2010), while the other did not (Dangour et al. 2010).
One area of research that has yet to be explored in this cohort is the effects of n-3 PUFAs on brain function in physiological terms. It is also possible that n-3 PUFAs, in combination with other compounds, may be more beneficial than treatment with n-3 PUFAs in isolation. The current study will explore several separate hypotheses within the same cohort. These are that Efalex Active 50+ may have a beneficial effect on:
- Cognitive performance
- Mental fatigue in response to cognitively demanding tasks
- Self-reported mood/well-being
- Task-related cerebral blood flow response
The proposed study therefore has two aims; the primary aim is to evaluate the cognitive and mood/well-being effects of Efalex Active 50+, a dietary supplement containing a number of potentially cognition enhancing components including DHA, phosphatidylserine, vitamin B12, folic acid and Ginkgo biloba, compared with placebo in a sample of older adults aged 50-70 years (Cognitive Study). The second is to evaluate the cerebral haemodynamic effects of the same treatment formulation in a sample drawn from the same population, with the addition of a third DHA-only arm (Hemodynamics Study). The intervention period will be 6 months.
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 |
|---|---|---|
| Efalex Active 50+ | Active comparator | Dietary Supplement: Efalex active 50+ |
| DHA-rich fish oil | Active comparator | Dietary Supplement: DHA rich fish oil |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Generally healthy
- Aged 50-70 years
- Low consumer of oily fish (≤ 1 portion/month)
- Has not taken vitamin/herbal supplements in the past 3 months
- Has not taken omega-3 supplement (including cod liver oil) in the past 2 years
Key exclusion criteria (9 listed)
- BMI > 35
- Smokes more than 15 cigarettes per day
- History of alcohol/drug abuse
- Currently taking statins/antidepressant/blood thinning medication
- Has high blood pressure
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 |
|---|---|---|
| Efalex active 50+4 x 500 mg Efalax Active 50+, to be taken daily for 6 months. | Dietary supplement | Efalex Active 50+ |
| DHA rich fish oil4 x 500 mg DHA rich tuna oil to be taken daily for 6 months | Dietary supplement | DHA-rich fish oil |
| Placebo4 x 500 mg capsules to be taken daily for 6 months | Dietary supplement | Placebo |
Primary outcome
Cognitive performance
Time frame: 6 months
Performance on a number of tasks assessing cognitive function across domains (attention, memory, executive function) will be measured.
2 secondary outcomes
Cerebral Hemodynamics
Time frame: 6 months
Mood/well-being
Time frame: 6 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 26 Sep 2012.
Related trials for Cognitive Function
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
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.
David O Kennedy, 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 Efalex active 50+ and DHA rich fish oil in people with Cognitive Function and Mood, 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 8 inclusion and 9 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 26 Sep 2012. 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?
Cognitive performance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2012.