SleepNCT03559361
26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Sleep Efficiency in Healthy Adults
A study testing EPA-rich and DHA-rich in people with Sleep, 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 a number of objective sleep measures (collected from Activity watches) and subjective sleep measures (collected from the Leeds Sleep Evaluation Questionnaire) before and after 26… Read more about this study
- Who is it for?
- Ages 25 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- 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
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2017to 20 Feb 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
- Sleeping pattern must include at least four consecutive nights per week that are the same
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 Sleep Efficiency 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 a number of objective sleep measures (collected from Activity watches) and subjective sleep measures (collected from the Leeds Sleep Evaluation Questionnaire) before and after 26 weeks of supplementation
- Conditions
- Sleep
- Being tested
- EPA-rich, DHA-rich, Olive oil Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPA-richDietary supplement
6 months omega 3 supplementation
DHA-richDietary supplement
6 months omega 3 supplementation
Olive oil PlaceboDietary 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: Olive oil Placebo |
| 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: EPA-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: DHA-rich |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective sleep efficiency
Sleep efficiency scores collected from research sleep watches
Measured: 26 weeks
Secondary outcomes (2)
Urinary melatonin
analysis of urine samples for objective measures of Melatonin
Measured: 26 weeks
Subjective Ratings of Sleep quality
Subjective sleep ratings collected from the leeds sleep evaluation questionnaire
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 posted18 Jun 2018
- Study start1 Mar 2017
- Primary completion20 Feb 2018
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- BASF
- Responsible party
- Principal investigator, Philippa Jackson, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559361
- Sponsor's protocol ID
- 44N5
- Status last verified
- Jun 2018
- First submitted
- 22 May 2018
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. 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 Sleep Efficiency in Healthy Adults
- ClinicalTrials.gov ID
- NCT03559361
- Acronym / sponsor ID
- 44N5
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- BASF
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 18 Jun 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 a number of objective sleep measures (collected from Activity watches) and subjective sleep measures (collected from the Leeds Sleep Evaluation Questionnaire) 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: Olive oil Placebo3 x 1 g capsules daily Placebo: olive oil |
| EPA-rich | Active comparator | Dietary Supplement: EPA-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: DHA-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 (4 listed)
- Aged 25 to 49 years inclusive
- Males and females
- Self-report of good health
- Sleeping pattern must include at least four consecutive nights per week that are the same
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 |
|---|---|---|
| EPA-rich6 months omega 3 supplementation | Dietary supplement | EPA-rich |
| DHA-rich6 months omega 3 supplementation | Dietary supplement | DHA-Rich |
| Olive oil Placebo6 months placebo supplementation | Dietary supplement | Olive oil Placebo |
Primary outcome
Objective sleep efficiency
Time frame: 26 weeks
Sleep efficiency scores collected from research sleep watches
2 secondary outcomes
Urinary melatonin
Time frame: 26 weeks
Subjective Ratings of Sleep quality
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 18 Jun 2018.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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 Sleep, 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 4 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 18 Jun 2018. 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?
Objective sleep efficiency (time frame: 26 weeks). 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 18 Jun 2018.