- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03158545
26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Cerebral Blood Flow in Healthy Adults
September 11, 2017 updated by: Philippa Jackson, Northumbria University
Efficacy Evaluation of 26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Cerebral Blood Flow 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 cerebral blood flow during a series of cognitive, mathematical subtraction tasks and subjective ratings of task difficulty before and after 26 weeks of supplementation
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tyne and Wear
-
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
- Northumbria University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 49 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 25 to 49 years inclusive
- Males and females
- Self-report of good health
Exclusion Criteria:
- 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 (see Appendix I)
- 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
- 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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Olive oil Placebo
3 x 1 g capsules daily Placebo: olive oil
|
olive oil
|
Active Comparator: EPA-rich
3 x 1 g capsules daily containing EPA-enriched oil
|
EPA-rich omega-3 oil
|
Active Comparator: DHA-rich
3 x 1 g capsules daily containing DHA-enriched oil
|
DHA-rich omega-3 oil
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral Blood Flow
Time Frame: Participants are assessed pre and post 6 months of supplementation
|
Near Infrared Spectroscopy Outcomes for cerebral blood flow measurment
|
Participants are assessed pre and post 6 months of supplementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive Performance
Time Frame: Participants are assessed pre and post 6 months of supplementation
|
performance on numerical subtraction tasks
|
Participants are assessed pre and post 6 months of supplementation
|
Subjective Task Difficulty
Time Frame: Participants are assessed pre and post 6 months of supplementation
|
participants rate how mentally challenging they find the cognitive tasks
|
Participants are assessed pre and post 6 months of supplementation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2016
Primary Completion (Actual)
September 4, 2017
Study Completion (Actual)
September 4, 2017
Study Registration Dates
First Submitted
May 16, 2017
First Submitted That Met QC Criteria
May 16, 2017
First Posted (Actual)
May 18, 2017
Study Record Updates
Last Update Posted (Actual)
September 12, 2017
Last Update Submitted That Met QC Criteria
September 11, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 44N4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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