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Completed

NCT Number: NCT03559361

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

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Key information

Conditions

Age range

25 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPA-rich

Dietary Supplement

6 months omega 3 supplementation

DHA-rich

Dietary Supplement

6 months omega 3 supplementation

Olive oil Placebo

Dietary Supplement

6 months placebo supplementation

Primary outcomes

  1. Objective sleep efficiency

    Time frame: 26 weeks

    Sleep efficiency scores collected from research sleep watches

Secondary outcomes

  1. Urinary melatonin

    Time frame: 26 weeks

    analysis of urine samples for objective measures of Melatonin

  2. Subjective Ratings of Sleep quality

    Time frame: 26 weeks

    Subjective sleep ratings collected from the leeds sleep evaluation questionnaire

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • BASF

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 18, 2018
Registry last updated
Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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