Sleep
Conditions
Brief 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 weeks of supplementation
Interventions
DIETARY_SUPPLEMENTEPA-rich
6 months omega 3 supplementation
DIETARY_SUPPLEMENTDHA-rich
6 months omega 3 supplementation
DIETARY_SUPPLEMENTOlive oil Placebo
6 months placebo supplementation
Sponsors
BASF
Northumbria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective sleep efficiency | 26 weeks | Sleep efficiency scores collected from research sleep watches |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary melatonin | 26 weeks | analysis of urine samples for objective measures of Melatonin |
| Subjective Ratings of Sleep quality | 26 weeks | Subjective sleep ratings collected from the leeds sleep evaluation questionnaire |
Countries
United Kingdom
Outcome results
None listed