26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Sleep Efficiency in Healthy Adults

Study Overview
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Brief Summary
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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

Official Title
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Efficacy Evaluation of 26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Sleep Efficiency in Healthy Adults

Conditions
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Sleep

Intervention / Treatment
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* Dietary Supplement: EPA-rich
* Dietary Supplement: DHA-rich
* Dietary Supplement: Olive oil Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Olive oil Placebo<br>3 x 1 g capsules daily Placebo: olive oil | Dietary Supplement: Olive oil Placebo<br>* 6 months placebo supplementation<br>|
| Active Comparator: EPA-rich<br>3 x 1 g capsules daily containing a SMEDDS formulation of an EPA-enriched oil totalling 900 mg EPA and 360 mg of DHA | Dietary Supplement: EPA-rich<br>* 6 months omega 3 supplementation<br>|
| Active Comparator: DHA-Rich<br>3 x 1 g capsules daily containing a SMEDDS formulation of an DHA-enriched oil totalling 900 mg DHA and 270 mg of EPA | Dietary Supplement: DHA-rich<br>* 6 months omega 3 supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective sleep efficiency | Sleep efficiency scores collected from research sleep watches | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary melatonin | analysis of urine samples for objective measures of Melatonin | 26 weeks | 
| Subjective Ratings of Sleep quality | Subjective sleep ratings collected from the leeds sleep evaluation questionnaire | 26 weeks |