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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03559361
• Other study ID #: 44N5
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: February 20, 2018

Study information

• Verified date: June 2018
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 weeks of supplementation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 20, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

Dietary Supplement:
• EPA-rich
6 months omega 3 supplementation
• DHA-rich
6 months omega 3 supplementation
• Olive oil Placebo
6 months placebo supplementation

Locations

Country	Name	City	State
United Kingdom	Northumbria University	Newcastle upon Tyne	Tyne And Wear

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	BASF

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective sleep efficiency	Sleep efficiency scores collected from research sleep watches	26 weeks
Secondary	Urinary melatonin	analysis of urine samples for objective measures of Melatonin	26 weeks
Secondary	Subjective Ratings of Sleep quality	Subjective sleep ratings collected from the leeds sleep evaluation questionnaire	26 weeks