Omegia Softgel Clinical Research Program

Sponsor
Chia Nan University of Pharmacy & Science (Other)
Overall Status
Completed
CT.gov ID
NCT05872178
Collaborator
(none)
40
1
2
20.5
1.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Omegia® Softgel -B
  • Dietary Supplement: Omegia® Softgel -A
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Chia Nan University of Pharmacy & Science
Actual Study Start Date :
Apr 15, 2021
Actual Primary Completion Date :
Dec 31, 2022
Actual Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Skin brightness [Subjects will be tested in the 4th week]

    Skin color difference analyzer (Chroma Meter MM500) was utilized to measure skin brightness. Units: arbitrary units

  2. Skin redness [Subjects will be tested in the 4th week]

    Skin color difference analyzer (Chroma Meter MM500) was utilized to measure skin redness. Units: arbitrary units

  3. Skin moisture [Subjects will be tested in the 4th week]

    Skin moisture meter (Corneometer CM825) was utilized to measure skin moisture. Units: arbitrary units

  4. Skin elasticity [Subjects will be tested in the 4th week]

    Skin elastometer (Soft Plus) was utilized to measure skin elasticity. Units: arbitrary units

  5. Facial skin pores [Subjects will be tested in the 4th week]

    VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin pores. Units: arbitrary units

  6. Facial skin texture [Subjects will be tested in the 4th week]

    VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin texture. Units: arbitrary units

  7. Skin collagen content [Subjects will be tested in the 4th week]

    Subcutaneous collagen scanner (DermaLab® Series SkinLab Combo) was utilized to measure skin collagen. Units: arbitrary units

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chia Nan University of Pharmacy & Science Tainan Taiwan 71710

Sponsors and Collaborators

  • Chia Nan University of Pharmacy & Science

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chia Nan University of Pharmacy & Science
ClinicalTrials.gov Identifier:
NCT05872178
Other Study ID Numbers:
  • TSMHIRB-2-029-2.2
First Posted:
May 24, 2023
Last Update Posted:
May 24, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2023