HealthyNCT01577004
Do Apolipoprotein E Polymorphisms Influence Risk of Cognitive Decline by Modulating Omega-3 Fatty Acid Metabolism?
A study testing omega-3 fatty acid in people with Healthy, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
BACKGROUND: Compared to the epsilon 2 or epsilon 3 alleles, the epsilon 4 allele of apolipoprotein E (ApoE4) is associated with twice the prevalence of late-onset Alzheimer's disease (AD). Epidemiological studies show that risk of AD varies inversely with consumption of omega-3 fatty acids from fish and seafood. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- omega-3 fatty acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2009to Oct 2011
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- MCI will be defined by Winblad et al. (33), with diagnosis confirmed by a geriatrician through neuropsychological evaluation done within the last 6 months.
- if diagnosis was done more than 6 months ago, the subject will be re-evaluated before inclusion to confirm MCI rather than conversion to AD.
Who cannot join
- tobacco
- malnutrition (assessed from blood albumin, haemoglobin and lipids)
- subjects already taking an EPA+DHA supplements
- swallowing problems, uncontrolled diabetes (raised fasting glucose, haemoglobin A1c)
- uncontrolled thyroid disease
- severe renal failure
Show all 14Show fewer
- chronic immune condition or inflammation (raised C-reactive protein, white cell count)
- cancer
- recent major surgery or cardiac event
- uncorrected visual or hearing problems
- dementia
- ongoing or past severe drug or alcohol abuse
- psychiatric difficulties or depression as evaluated by the geriatric depression scale test (34)
- use of psychotropic medications except for short-acting benzodiazepines taken before sleep.
Trial locations and contacts
1 site in 1 country.
About this study
BACKGROUND: Compared to the epsilon 2 or epsilon 3 alleles, the epsilon 4 allele of apolipoprotein E (ApoE4) is associated with twice the prevalence of late-onset Alzheimer's disease (AD). Epidemiological studies show that risk of AD varies inversely with consumption of omega-3 fatty acids from fish and seafood. Despite apparently lower fish intake in AD, pooled analysis of the literature shows that plasma and brain docosahexaenoic acid (DHA) is actually the same in AD as in healthy age-matched controls. Fish oil trials in AD are also not convincing. We recently shown that ApoE4 carriers have 41% higher fasting plasma EPA and DHA compared to non-carriers, but the plasma EPA and DHA response to fish oil in ApoE4 carriers was half that seen in non-carriers.
HYPOTHESES: (i) Carriers of ApoE4 have altered metabolism of carbon-13 (13C)-DHA as well as EPA and DHA provided in a dietary supplement. (ii) A dietary supplement of EPA+DHA will improve cognitive performance but only in non-carriers of ApoE4.
Read more
OBJECTIVES: In both carriers and non-carriers of ApoE4, to compare whether- i) ApoE4 alters incorporation of 13C-DHA into plasma lipids or its beta-oxidation.
ii) 13C-DHA metabolism changes while on a dietary supplement of EPA+DHA; iii) Better cognitive performance occurs while on EPA+DHA and is linked to raising plasma EPA and/or DHA.
EXPERIMENTAL METHODS: Participants older than 50 y old and not demented were enrolled. DHA metabolism was evaluated using both 13C-DHA and an EPA+DHA supplement (2.4 g/d for 5 mo; n = 20/gp). Before and in the last month of supplementation, plasma uptake and beta-oxidation of 50 mg of 13C-DHA was followed during one month. Blood omega-3 fatty acids was evaluated monthly during the supplementation period. Cognitive testing was performed before and 4 months after starting the omega-3 fatty acid supplement.
IMPLICATIONS: This project will help explain the apparent link that is newly emerging between ApoE polymorphisms, altered omega-3 fatty acid metabolism and risk of cognitive decline, and should help in the development of nutraceutical-based clinical trials using fish oil for the elderly.
Read the detailed description
To come
- Conditions
- Healthy
- Being tested
- omega-3 fatty acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 fatty acidDietary supplement
Also called Ocean Nutrition, Dartmouth, NS
Subjects will be given four 1 g capsules of fish oil providing 1.4 g/d of EPA and 1.0 g/d of DHA as ethyl esters (Ocean Nutrition, Dartmouth, NS), which is similar to the dose used in previous studies with MCI and AD (20, 21).
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 fatty acid supplement | Experimental | Data obtained after the intervention was compared to baseline data Receives: Dietary Supplement: omega-3 fatty acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
13C-DHA incorporation into plasma lipids or beta-oxidation.
Before and in the last month of supplementation, plasma incorporation and beta-oxidation of 50 mg of 13C-DHA will be followed during one month. Blood and breath samples will be collected at time 0 h, 1 h, 2 h, 4 h, 6 h, 8 h, 24 h, 7 d, 14 d, 21 d, and 28 d.
Measured: one month
Secondary outcomes (1)
Cognitive performance compared to baseline
Cognitive testing was done before and 4 months after starting the omega-3 fatty acid supplement.
Measured: 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startJul 2009
- Primary completionOct 2011
- Study completionOct 2011
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 HealthyStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mélanie Plourde, Université de Sherbrooke
- Investigators
- Melanie Plourde, Ph.D., Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577004
- Sponsor's protocol ID
- AFMNet-1
- Other IDs
- Discovery grant
- Status last verified
- Apr 2012
- First submitted
- 24 Feb 2012
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Plourde M, Chouinard-Watkins R, Rioux-Perreault C, Fortier M, Dang MT, Allard MJ, Tremblay-Mercier J, Zhang Y, Lawrence P, Vohl MC, Perron P, Lorrain D, Brenna JT, Cunnane SC. Kinetics of 13C-DHA before and during fish-oil supplementation in healthy older individuals. Am J Clin Nutr. 2014 Jul;100(1):105-12. doi: 10.3945/ajcn.113.074708. Epub 2014 May 14.
PubMed 24829492
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Apolipoprotein E Polymorphisms Influence Risk of Cognitive Decline by Modulating Omega-3 Fatty Acid Metabolism?
- ClinicalTrials.gov ID
- NCT01577004
- Acronym / sponsor ID
- AFMNet-1
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 13 Apr 2012 (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.
BACKGROUND: Compared to the epsilon 2 or epsilon 3 alleles, the epsilon 4 allele of apolipoprotein E (ApoE4) is associated with twice the prevalence of late-onset Alzheimer's disease (AD). Epidemiological studies show that risk of AD varies inversely with consumption of omega-3 fatty acids from fish and seafood. Despite apparently lower fish intake in AD, pooled analysis of the literature shows that plasma and brain docosahexaenoic acid (DHA) is actually the same in AD as in healthy age-matched controls. Fish oil trials in AD are also not convincing. We recently shown that ApoE4 carriers have 41% higher fasting plasma EPA and DHA compared to non-carriers, but the plasma EPA and DHA response to fish oil in ApoE4 carriers was half that seen in non-carriers.
HYPOTHESES: (i) Carriers of ApoE4 have altered metabolism of carbon-13 (13C)-DHA as well as EPA and DHA provided in a dietary supplement. (ii) A dietary supplement of EPA+DHA will improve cognitive performance but only in non-carriers of ApoE4.
OBJECTIVES: In both carriers and non-carriers of ApoE4, to compare whether- i) ApoE4 alters incorporation of 13C-DHA into plasma lipids or its beta-oxidation.
ii) 13C-DHA metabolism changes while on a dietary supplement of EPA+DHA; iii) Better cognitive performance occurs while on EPA+DHA and is linked to raising plasma EPA and/or DHA.
EXPERIMENTAL METHODS: Participants older than 50 y old and not demented were enrolled. DHA metabolism was evaluated using both 13C-DHA and an EPA+DHA supplement (2.4 g/d for 5 mo; n = 20/gp). Before and in the last month of supplementation, plasma uptake and beta-oxidation of 50 mg of 13C-DHA was followed during one month. Blood omega-3 fatty acids was evaluated monthly during the supplementation period. Cognitive testing was performed before and 4 months after starting the omega-3 fatty acid supplement.
IMPLICATIONS: This project will help explain the apparent link that is newly emerging between ApoE polymorphisms, altered omega-3 fatty acid metabolism and risk of cognitive decline, and should help in the development of nutraceutical-based clinical trials using fish oil for the elderly.
Detailed description
To come
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omega-3 fatty acid supplement | Experimental | Dietary Supplement: omega-3 fatty acidData obtained after the intervention was compared to baseline data |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- MCI will be defined by Winblad et al. (33), with diagnosis confirmed by a geriatrician through neuropsychological evaluation done within the last 6 months.
- if diagnosis was done more than 6 months ago, the subject will be re-evaluated before inclusion to confirm MCI rather than conversion to AD.
Key exclusion criteria (14 listed)
- tobacco
- malnutrition (assessed from blood albumin, haemoglobin and lipids)
- subjects already taking an EPA+DHA supplements
- swallowing problems, uncontrolled diabetes (raised fasting glucose, haemoglobin A1c)
- uncontrolled thyroid disease
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 |
|---|---|---|
| omega-3 fatty acidAlso: Ocean Nutrition, Dartmouth, NSSubjects will be given four 1 g capsules of fish oil providing 1.4 g/d of EPA and 1.0 g/d of DHA as ethyl esters (Ocean Nutrition, Dartmouth, NS), which is similar to the dose used in previous studies with MCI and AD (20, 21). | Dietary supplement | Omega-3 fatty acid supplement |
Primary outcome
13C-DHA incorporation into plasma lipids or beta-oxidation.
Time frame: one month
Before and in the last month of supplementation, plasma incorporation and beta-oxidation of 50 mg of 13C-DHA will be followed during one month. Blood and breath samples will be collected at time 0 h, 1 h, 2 h, 4 h, 6 h, 8 h, 24 h, 7 d, 14 d, 21 d, and 28 d.
1 secondary outcome
Cognitive performance compared to baseline
Time frame: 5 month
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 13 Apr 2012.
- Derived from this study: PubMed 24829492Plourde M, Chouinard-Watkins R, Rioux-Perreault C, Fortier M, Dang MT, Allard MJ, Tremblay-Mercier J, Zhang Y, Lawrence P, Vohl MC, Perron P, Lorrain D, Brenna JT, Cunnane SC. Kinetics of 13C-DHA before and during fish-oil supplementation in healthy older individuals. Am J Clin Nutr. 2014 Jul;100(1):105-12. doi: 10.3945/ajcn.113.074708. Epub 2014 May 14.
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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.
Melanie Plourde, Ph.D. principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega-3 fatty acid in people with Healthy, run by Université de Sherbrooke at 1 site in Canada.
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 14 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 13 Apr 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 Canada. 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. 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?
13C-DHA incorporation into plasma lipids or beta-oxidation. (time frame: one month). 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 NCT01577004, 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 13 Apr 2012.