Nutritional Study of Fish Oil in Skin Quality in Healthy Women

NCT05128240 | Unknown

• 1 other identifier: P237921
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Health

Keywords

skin; inflammation; wrinkles; trans epithelial water loss; fish oil; LCMUFA

Outcome Measures

Primary Outcomes (1)

• Determine the change in skin quality of healthy women after supplementation with fish oil compared to corn oil

  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 Outcomes (1)

• 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

  3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

4x1g corn oil capsules

Dietary Supplement: Placebo

Ceto 10

EXPERIMENTAL

4x1g capsules containing containing broad spectrum marine oil from north atlantic fish

Dietary Supplement: Ceto 10

Interventions

Placebo DIETARY_SUPPLEMENT

1g corn oil capsules

Placebo

Ceto 10 DIETARY_SUPPLEMENT

1g capsules containing oil broad spectrum marine oil from north atlantic fish

Ceto 10

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Participation is based on self-assessment of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Epax Norway AS: lead
• Møreforsking AS: collaborator

Study Sites (1)

Møreforsking AS

Ålesund, 6006, Norway

RECRUITING

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Midtbø, PhD

  Møreforsking AS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Derek Tobin, PhD

CONTACT

derek.tobin@pelagia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Interventions are given as 1g bovine capsules of equal size, weight and appearance, and provided in identical bottles with a coded label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo controlled, double blind intervention study.

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 19, 2021
• Study Start: August 23, 2021
• Primary Completion: December 20, 2021
• Study Completion: March 1, 2022
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)