Omegia Softgel Clinical Research Program

May 22, 2023 updated by: Chia Nan University of Pharmacy ＆ Science

Chia Nan University of Pharmacy & Science

Evaluate the improvement of regulation of skin and blood index composition after consumption of Omegia® Softgel

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The blood biochemical analysis at Weeks 0 and 12, including Catalase, Tumor necrosis factor-α, Cholesterol, Triglyceride, High-density lipoprotein-Cholesterol and Low-density lipoprotein- Cholesterol.

The Skin assessment at Weeks 0, 4 and 12, including Skin brightness, Skin redness sensitivity index, Skin moisture, Skin elasticity, Facial skin pores, Facial skin texture and Skin collagen content.

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

  • Taiwan
      • Tainan, Taiwan, 71710
        • Chia Nan University of Pharmacy & Science

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

● Female subjects older than 45 years

Exclusion Criteria:

  • Involuntary subjects
  • Skin disease, liver cirrhosis or chronic renal failure
  • Those with known cosmetic, drug or food allergies
  • Pregnant women and nursing mothers.
  • Those taking chronic disease medication
  • The subject has received laser facial treatment, fruit acid facial peeling, long-term sunlight, etc. within four weeks of the test

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Omegia® Softgel -A
Take Omegia® Softgel -A once a day for 12 weeks
Dietary supplement: Omegia® Softgel -A
How to use: Take once a day for 12 weeks Subject precautions: If the health products and cosmetic care products used contain sea buckthorn ingredients, stop using them.
Experimental: Omegia® Softgel -B
Take Omegia® Softgel-B once a day for 12 weeks
Dietary supplement: Omegia® Softgel -B
How to use: Take once a day for 12 weeks Subject precautions: If the health products and cosmetic care products used contain sea buckthorn ingredients, stop using them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin brightness
Time Frame: Subjects will be tested in the 4th week
Skin color difference analyzer (Chroma Meter MM500) was utilized to measure skin brightness. Units: arbitrary units
Subjects will be tested in the 4th week
Skin redness
Time Frame: Subjects will be tested in the 4th week
Skin color difference analyzer (Chroma Meter MM500) was utilized to measure skin redness. Units: arbitrary units
Subjects will be tested in the 4th week
Skin moisture
Time Frame: Subjects will be tested in the 4th week
Skin moisture meter (Corneometer CM825) was utilized to measure skin moisture. Units: arbitrary units
Subjects will be tested in the 4th week
Skin elasticity
Time Frame: Subjects will be tested in the 4th week
Skin elastometer (Soft Plus) was utilized to measure skin elasticity. Units: arbitrary units
Subjects will be tested in the 4th week
Facial skin pores
Time Frame: Subjects will be tested in the 4th week
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin pores. Units: arbitrary units
Subjects will be tested in the 4th week
Facial skin texture
Time Frame: Subjects will be tested in the 4th week
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin texture. Units: arbitrary units
Subjects will be tested in the 4th week
Skin collagen content
Time Frame: Subjects will be tested in the 4th week
Subcutaneous collagen scanner (DermaLab® Series SkinLab Combo) was utilized to measure skin collagen. Units: arbitrary units
Subjects will be tested in the 4th week

Collaborators and Investigators

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

Sponsor

Chia Nan University of Pharmacy ＆ Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 15, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

May 5, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSMHIRB-2-029-2.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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