NCT02661698

Brief Summary

This study will evaluate the absorption of two different dietary supplements containing the omega 3 fatty acids eicosapentaenoic acid and docosahexaenoic acid over 24 hours via venous blood plasma following a single dose taken at bed time. In addition, the circadian rhythm of fatty acid metabolism will also be assessed following the placebo intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 8, 2016

Status Verified

September 1, 2016

Enrollment Period

8 months

First QC Date

January 14, 2016

Last Update Submit

November 7, 2016

Conditions

Lipid Absorption and Metabolism

Outcome Measures

Primary Outcomes (1)

  • The 24 hour Area Under the Curve (AUC) of plasma concentrations of DHA and EPA

    In order to assess the absorption and its effect on total exposure of each treatment in comparison to placebo, plasma data will be used to calculate the 24 hour Area Under the Curve (AUC) for the fatty acids DHA and EPA.

    24 hours

Secondary Outcomes (2)

  • Mesor of plasma fatty acids (DHA and EPA)

    24 hours

  • Acrophase of plasma fatty acids (DHA and EPA)

    24 hours

Study Arms (4)

Placebo 1

PLACEBO COMPARATOR

Placebo All participants will be given a placebo for the first visit. The other 3 arms will be randomised in a counterbalanced order.

Dietary Supplement: Placebo

Placebo 2

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

DHA rich oil

ACTIVE COMPARATOR

Omega-3 oil: DHA enriched

Dietary Supplement: Omega-3 oil: DHA enriched

EPA rich oil

ACTIVE COMPARATOR

Omega-3 oil: EPA enriched

Dietary Supplement: Omega-3 oil: EPA enriched

Interventions

Omega-3 oil: DHA enrichedDIETARY_SUPPLEMENT

3 x 1 g capsules containing a SMEDDS formulation of an DHA-enriched oil: 50% DHA + 15% EPA totalling 900 mg DHA and 270 mg of EPA

DHA rich oil
PlaceboDIETARY_SUPPLEMENT

3 x 1 g capsules Placebo: olive oil

Placebo 1Placebo 2
Omega-3 oil: EPA enrichedDIETARY_SUPPLEMENT

3 x 1 g capsules containing a SMEDDS formulation of an EPA-enriched oil: 50% EPA + 20% DHA totalling 900 mg EPA and 360 mg of DHA

EPA rich oil

Eligibility Criteria

Age25 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 25 to 49 years inclusive
  • Males and females
  • Of any ethnic origin
  • Self-report of good health

You may not qualify if:

  • Habitual consumption of oily fish exceeds one fish meal per week
  • Consumption of omega-3 dietary supplements in the previous 4 weeks
  • 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
  • History or current diagnosis of drug/alcohol abuse
  • Currently participating in or in the past 4 weeks participated in other clinical or nutrition intervention studies
  • High blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
  • Body Mass Index outside of the range 18-35 kg/m2
  • Pregnant, trying to get pregnant or breast feeding
  • Blood donation of more than 300 mL during the three months prior to screening (470 mL is given at the average donation).
  • Sleep disturbances and/or are taking sleep aid medication
  • Currently taking blood thinning medication (e.g. aspirin, warfarin, heparin)
  • Habitually use of dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total)
  • Blood disorders (e.g. anaemia, haemophilia, thrombocytosis)
  • Diagnosis of type I or type II diabetes
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

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

Location

Study Officials

  • Philippa A Jackson, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 22, 2016

Study Start

February 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 8, 2016

Record last verified: 2016-09

Locations

GB(1)