- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03559361
26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Sleep Efficiency in Healthy Adults
June 5, 2018 updated by: Philippa Jackson, Northumbria University
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
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
- Sleeping pattern must include at least four consecutive nights per week that are the same
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
- 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
- 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
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
|
6 months placebo supplementation
|
Active Comparator: EPA-rich
3 x 1 g capsules daily containing a SMEDDS formulation of an EPA-enriched oil totalling 900 mg EPA and 360 mg of DHA
|
6 months omega 3 supplementation
|
Active Comparator: DHA-Rich
3 x 1 g capsules daily containing a SMEDDS formulation of an DHA-enriched oil totalling 900 mg DHA and 270 mg of EPA
|
6 months omega 3 supplementation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective sleep efficiency
Time Frame: 26 weeks
|
Sleep efficiency scores collected from research sleep watches
|
26 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary melatonin
Time Frame: 26 weeks
|
analysis of urine samples for objective measures of Melatonin
|
26 weeks
|
Subjective Ratings of Sleep quality
Time Frame: 26 weeks
|
Subjective sleep ratings collected from the leeds sleep evaluation questionnaire
|
26 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
March 1, 2017
Primary Completion (Actual)
February 20, 2018
Study Completion (Actual)
February 20, 2018
Study Registration Dates
First Submitted
May 22, 2018
First Submitted That Met QC Criteria
June 5, 2018
First Posted (Actual)
June 18, 2018
Study Record Updates
Last Update Posted (Actual)
June 18, 2018
Last Update Submitted That Met QC Criteria
June 5, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 44N5
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
product manufactured in and exported from the U.S.
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.
Clinical Trials on Sleep
-
University of Wisconsin, MadisonPhilips HealthcareCompletedSleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
-
Brain Electrophysiology Laboratory CompanyRecruiting
-
University GhentEuropean CommissionEnrolling by invitation
-
Northumbria UniversityCompletedSleep | Mood | Poor Quality Sleep | Good Sleep HabitUnited Kingdom
-
Baylor College of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruiting
-
Brain Electrophysiology Laboratory CompanyCompletedSleep | Sleep HygieneUnited States
-
Koko Home, Inc.Stanford UniversityRecruitingSleep Disorder | Insomnia | Sleep Initiation and Maintenance Disorders | Sleep | Sleep Disturbance | Sleep HygieneUnited States
-
Medical College of WisconsinChildren's Hospital and Health System Foundation, Wisconsin; Divine Savior...Active, not recruitingSleep | Sleep HygieneUnited States
-
Aretaieion University HospitalRecruitingSleep Disorder | Sleep Initiation and Maintenance Disorders | Sleep | Sleep Disturbance | Surgery | Anesthesia | Sleep Fragmentation | Sleep Disorders, Circadian RhythmGreece
-
Brigham and Women's HospitalCharite University, Berlin, Germany; Stanford UniversityRecruitingSleep Disorders, Intrinsic | Sleep Wake Disorders | Sleep Disorders, Circadian Rhythm | Advanced Sleep Phase Syndrome (ASPS) | Delayed Sleep Phase Syndrome | Shift-Work Sleep Disorder | Delayed Sleep Phase | Non-24 Hour Sleep-Wake Disorder | Advanced Sleep Phase Syndrome | Advanced Sleep Phase | Irregular... and other conditionsUnited States
Clinical Trials on Olive oil Placebo
-
Harvard School of Public Health (HSPH)CompletedCardiovascular Disease
-
Universitas SriwijayaActive, not recruitingCapecitabine | Hand and Foot Syndrome | Hand and Foot Skin ReactionIndonesia
-
Minia UniversityRecruitingOrthodontic Tooth MovementEgypt
-
Spanish National Research CouncilAndalusian Health Service; Universidad Pablo de OlavideRecruitingType II Diabetes Mellitus | Diabetic PatientsSpain
-
University of LimerickCompletedCardiovascular Diseases | Obesity | DiabetesIreland
-
Université Catholique de LouvainCompleted
-
Javad NasrollahzadehShahid Beheshti University of Medical SciencesCompletedCardiovascular Risk FactorIran, Islamic Republic of
-
University of BarcelonaHospital Clinic of Barcelona; Institut d'Investigacions Biomèdiques August...Completed
-
Hospital General Nuestra Señora del PradoCompleted
-
Griffin HospitalCompletedType 2 DiabetesUnited States