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

NCT03559361 | Completed

• 1 other identifier: 44N5
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• Objective sleep efficiency

  Sleep efficiency scores collected from research sleep watches

  26 weeks

Secondary Outcomes (2)

• Urinary melatonin

  26 weeks

• Subjective Ratings of Sleep quality

  26 weeks

Study Arms (3)

Olive oil Placebo

PLACEBO COMPARATOR

3 x 1 g capsules daily Placebo: olive oil

Dietary Supplement: Olive oil Placebo

EPA-rich

ACTIVE COMPARATOR

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

DHA-Rich

ACTIVE COMPARATOR

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

Interventions

EPA-rich DIETARY_SUPPLEMENT

6 months omega 3 supplementation

EPA-rich

DHA-rich DIETARY_SUPPLEMENT

6 months omega 3 supplementation

DHA-Rich

Olive oil Placebo DIETARY_SUPPLEMENT

6 months placebo supplementation

Olive oil Placebo

Eligibility Criteria

• Age: 25 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• BASF: collaborator

Study Sites (1)

Northumbria University

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

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 18, 2018
• Study Start: March 1, 2017
• Primary Completion: February 20, 2018
• Study Completion: February 20, 2018
• Last Updated: June 18, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)