Efficacy Testing of Collagen Elixir

Sponsor
TCI Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04878536
Collaborator
(none)
60
1
2
5.3
11.4

Study Details

Study Description

Brief Summary

To assess Isagenix-Collagen Elixir on skin condition improvement

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Collagen drink
  • Dietary Supplement: Blank
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Efficacy Testing of Collagen Drink
Actual Study Start Date :
May 18, 2021
Actual Primary Completion Date :
Jul 30, 2021
Actual Study Completion Date :
Oct 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo drink

Dietary Supplement: Blank
Placebo drink

Experimental: Collagen drink

Dietary Supplement: Collagen drink
Testing product
Other Names:
  • Isagenix-Collagen Elixir
  • Outcome Measures

    Primary Outcome Measures

    1. The change of skin wrinkles [Change from Baseline skin wrinkles at 4 weeks]

      VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units

    2. The change of skin texture [Change from Baseline skin texture at 4 weeks]

      VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units

    3. The change of skin collagen density [Change from Baseline skin collagen density at 4 weeks]

      DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units

    4. The change of skin elasticity [Change from Baseline skin elasticity at 4 weeks]

      Soft Plus was utilized to measure skin elasticity. Units: arbitrary units

    5. The change of MMP-1 of blood [Change from Baseline MMP-1 at 4 weeks]

      Venous blood was sampled to measure MMP-1

    6. The change of TIMP-1 of blood [Change from Baseline TIMP-1 at 4 weeks]

      Venous blood was sampled to measure TIMP-1

    Secondary Outcome Measures

    1. The change of skin melanin index [Change from Baseline skin melanin index at 4 weeks]

      Soft Plus was utilized to measure skin melanin index. Units: arbitrary units

    2. The change of skin L* value [Change from Baseline L* value at 4 weeks]

      Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100

    3. The change of skin moisture [Change from Baseline skin moisture at 4 weeks]

      Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120

    4. The change of skin spots [Change from Baseline skin spots at 4 weeks]

      VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units

    5. The change of skin UV spots [Change from Baseline skin UV spots at 4 weeks]

      VISIA Complexion Analysis System was utilized to measure skin UV spots. Units: arbitrary units

    6. The change of skin brown spots [Change from Baseline skin brown spots at 4 weeks]

      VISIA Complexion Analysis System was utilized to measure skin brown spots. Units: arbitrary units

    7. The change of TNF-α of blood [Change from Baseline TNF-α at 4 weeks]

      Venous blood was sampled to measure TNF-α

    8. The change of IL-10 of blood [Change from Baseline IL-10 at 4 weeks]

      Venous blood was sampled to measure IL-10

    9. The change of SOD-RBC of blood [Change from Baseline SOD-RBC at 4 weeks]

      Venous blood was sampled to measure SOD-RBC

    10. The change of f-thiols of blood [Change from Baseline f-thiols at 4 weeks]

      Venous blood was sampled to measure f-thiols

    11. The change of t-GSH of blood [Change from Baseline t-GSH at 4 weeks]

      Venous blood was sampled to measure t-GSH

    12. The change of GST-RBC of blood [Change from Baseline GST-RBC at 4 weeks]

      Venous blood was sampled to measure GST-RBC

    13. The change of MDA of blood [Change from Baseline MDA at 4 weeks]

      Venous blood was sampled to measure MDA

    14. The change of blood total antioxidant capacity (TAC) [Change from Baseline TAC at 4 weeks]

      Venous blood was sampled to measure concentrations of TAC

    Other Outcome Measures

    1. The change of total cholesterol of blood [Change from Baseline total cholesterol at 4 weeks]

      Venous blood was sampled to measure total cholesterol

    2. The change of triglyceride of blood [Change from Baseline triglyceride at 4 weeks]

      Venous blood was sampled to measure triglyceride

    3. The change of SGOT of blood [Change from Baseline SGOT at 4 weeks]

      Venous blood was sampled to measure SGOT

    4. The change of SGPT of blood [Change from Baseline SGPT at 4 weeks]

      Venous blood was sampled to measure SGPT

    5. The change of BUN of blood [Change from Baseline BUN at 4 weeks]

      Venous blood was sampled to measure BUN

    6. The change of creatinine of blood [Change from Baseline creatinine at 4 weeks]

      Venous blood was sampled to measure creatinine

    7. The change of uric acid of blood [Change from Baseline uric acid at 4 weeks]

      Venous blood was sampled to measure uric acid

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy adults aged above 20 years old
    Exclusion Criteria:
    • Subject who is not willing to participate in this study.

    • Patients with diseases of the skin, liver, kidney.

    • Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.

    • Female who is pregnant or nursing or planning to become pregnant during the course of the study.

    • Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.

    • Constant drug use

    • Participated cosmetic product human study in the past 3 months.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • TCI Co., Ltd.

    Investigators

    • Principal Investigator: Chia-Hua Liang, Chia Nan University of Pharmacy & Science

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TCI Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT04878536
    Other Study ID Numbers:
    • 21-042-B
    First Posted:
    May 7, 2021
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    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 Mar 31, 2022