Nutritional Study of Fish Oil in Skin Quality in Healthy Women (OPTIHUD)

November 16, 2021 updated by: Epax Norway AS

A Randomised, Two-armed, Double-blinded Nutritional Study of Fish Oil on Skin Quality in Healthy Women

The skin acts as a barrier against the external environment and prevents water loss from the body. Aging is a natural process leading to changes in the skin and fish oil has been shown to prevent inflammation, hyperpigmentation and UV-damage. This pilot study will determine skin characteristics after intervention with north atlantic fish oil.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Women will be recruited to a placebo or fish oil group and be examined at pre- and post for skin quality parameters such as wrinkles, fine lines and trans-epithelial water loss.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Norway
      • Ålesund, Norway, 6006
        • Recruiting
        • Møreforsking AS
        • Contact:
          • Lise Midtbø, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Healthy women in the age of 30-65

Able to follow the following dietary restriction for 4 months (4 weeks wash-out, 3 months intervention):

  • Do not take omega-3 supplements
  • do not take supplements containing vitamin A
  • do not take supplements containing collagen
  • try to avoid using skin products containing vitamin A
  • do not undergo skin treatment

Exclusion Criteria:

Pregnancy or breast feeding known allergy to seafood skin treatment the last 6 months planned skin treatment during the study period

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
4x1g corn oil capsules
Dietary supplement: Placebo
1g corn oil capsules
Experimental: Ceto 10
4x1g capsules containing containing broad spectrum marine oil from north atlantic fish
Dietary supplement: Ceto 10
1g capsules containing oil broad spectrum marine oil from north atlantic fish

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the change in skin quality of healthy women after supplementation with fish oil compared to corn oil
Time Frame: 3 months
Changes in quantitative analysis of facial inflammation, wrinkles and fine lines and skin texture will be performed using the VISIA Skin Analysis system. Measurements will be made at baseline and at end of supplementation period.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the change in omega-3 index (%EPA and DHA in red blood cells) after daily intake of 4g of north atlantic fish oil compared to placebo
Time Frame: 3 months
Fatty acid profiles will be measured from blood samples using the Omega-quant test
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epax Norway AS

Collaborators

Møreforsking AS

Investigators

  • Principal Investigator: Lisa Midtbø, PhD, Møreforsking AS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2021

Primary Completion (Anticipated)

December 20, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

November 4, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P237921

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be presented as collective statistical data. Individual participant data may be shared on request, or if demanded by journals

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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