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

Northumbria University

Status: Completed

Conditions: Sleep

Treatments: Dietary Supplement: DHA-rich; Dietary Supplement: EPA-rich; Dietary Supplement: Olive oil Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03559361

44N5

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: All

Ages: 25 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

Olive oil Placebo

Placebo Comparator group

Description:

3 x 1 g capsules daily Placebo: olive oil

Treatment:

Dietary Supplement: Olive oil Placebo

EPA-rich

Active Comparator group

Description:

3 x 1 g capsules daily containing a SMEDDS formulation of an EPA-enriched oil totalling 900 mg EPA and 360 mg of DHA

Treatment:

Dietary Supplement: EPA-rich

DHA-Rich

Active Comparator group

Description:

3 x 1 g capsules daily containing a SMEDDS formulation of an DHA-enriched oil totalling 900 mg DHA and 270 mg of EPA

Treatment:

Dietary Supplement: DHA-rich