Back to resultsInvestigation of the Efficacies of Multi Berries Juice on Anti Oxidant Effect and Improvement of Skin Conditions
Primary Purpose
Skin Condition, Anti Oxidative Stress
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
multi berries juice
Placebo drink
Sponsored by
About this trial
This is an interventional other trial for Skin Condition
Eligibility Criteria
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
Sites / Locations
- Chia Nan University of Pharmacy & Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo drink
multi berries juice
Arm Description
Outcomes
Primary Outcome Measures
The change of skin UV spots
VISIA Complexion Analysis System was utilized to measure skin UV spots. Units: arbitrary units
The change of skin melanin index
Soft Plus was utilized to measure skin melanin index. Units: arbitrary units
The change of blood SOD content
Venous blood was sampled to measure concentrations of SOD
The change of blood total antioxidant capacity (TAC)
Venous blood was sampled to measure concentrations of TAC
The change of skin L* value
Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100
The change of skin spots
VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units
The change of skin brown spots
VISIA Complexion Analysis System was utilized to measure skin brown spots. Units: arbitrary units
Secondary Outcome Measures
The change of skin moisture
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
The change of skin a* value
Chroma Meter MM500 was utilized to measure skin a* value. Units: arbitrary units
The change of skin elasticity
Soft Plus was utilized to measure skin elasticity. Units: arbitrary units
The change of skin wrinkles
VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
The change of skin texture
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
The change of skin pores
VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
The change of skin collagen density
DermaLab® Series SkinLab Combo was utilized to measure skin collagen density. Units: arbitrary units
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04878523
Brief Title
Investigation of the Efficacies of Multi Berries Juice on Anti Oxidant Effect and Improvement of Skin Conditions
Official Title
Investigation of the Efficacies of Multi Berries Juice on Anti Oxidant Effect and Improvement of Skin Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
February 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCI Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To assess multi berries juice on anti-oxidant effect and skin condition improvement
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Condition, Anti Oxidative Stress
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo drink
Arm Type
Placebo Comparator
Arm Title
multi berries juice
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
multi berries juice
Other Intervention Name(s)
Sei Bella™ Pure Essence Whitening Multi-Berries Drink
Intervention Description
Testing product
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo drink
Intervention Description
Blank
Primary Outcome Measure Information:
Title
The change of skin UV spots
Description
VISIA Complexion Analysis System was utilized to measure skin UV spots. Units: arbitrary units
Time Frame
Change from Baseline skin UV spots at 8 weeks
Title
The change of skin melanin index
Description
Soft Plus was utilized to measure skin melanin index. Units: arbitrary units
Time Frame
Change from Baseline skin melanin index at 8 weeks
Title
The change of blood SOD content
Description
Venous blood was sampled to measure concentrations of SOD
Time Frame
Change from Baseline SOD content at 8 weeks
Title
The change of blood total antioxidant capacity (TAC)
Description
Venous blood was sampled to measure concentrations of TAC
Time Frame
Change from Baseline TAC at 8 weeks
Title
The change of skin L* value
Description
Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100
Time Frame
Change from Baseline L* value at 8 weeks
Title
The change of skin spots
Description
VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units
Time Frame
Change from Baseline skin spots at 8 weeks
Title
The change of skin brown spots
Description
VISIA Complexion Analysis System was utilized to measure skin brown spots. Units: arbitrary units
Time Frame
Change from Baseline skin brown spots at 8 weeks
Secondary Outcome Measure Information:
Title
The change of skin moisture
Description
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
Time Frame
Change from Baseline skin moisture at 4 weeks
Title
The change of skin a* value
Description
Chroma Meter MM500 was utilized to measure skin a* value. Units: arbitrary units
Time Frame
Change from Baseline a* value at 8 weeks
Title
The change of skin elasticity
Description
Soft Plus was utilized to measure skin elasticity. Units: arbitrary units
Time Frame
Change from Baseline skin elasticity at 8 weeks
Title
The change of skin wrinkles
Description
VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
Time Frame
Change from Baseline skin wrinkles at 8 weeks
Title
The change of skin texture
Description
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Time Frame
Change from Baseline skin texture at 8 weeks
Title
The change of skin pores
Description
VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
Time Frame
Change from Baseline skin pores at 8 weeks
Title
The change of skin collagen density
Description
DermaLab® Series SkinLab Combo was utilized to measure skin collagen density. Units: arbitrary units
Time Frame
Change from Baseline skin collagen density at 8 weeks
Other Pre-specified Outcome Measures:
Title
The change of total cholesterol of blood
Description
Venous blood was sampled to measure total cholesterol
Time Frame
Change from Baseline total cholesterol at 8 weeks
Title
The change of triglyceride of blood
Description
Venous blood was sampled to measure triglyceride
Time Frame
Change from Baseline triglyceride at 8 weeks
Title
The change of SGOT of blood
Description
Venous blood was sampled to measure SGOT
Time Frame
Change from Baseline SGOT at 8 weeks
Title
The change of SGPT of blood
Description
Venous blood was sampled to measure SGPT
Time Frame
Change from Baseline SGPT at 8 weeks
Title
The change of BUN of blood
Description
Venous blood was sampled to measure BUN
Time Frame
Change from Baseline BUN at 8 weeks
Title
The change of uric acid of blood
Description
Venous blood was sampled to measure uric acid
Time Frame
Change from Baseline uric acid at 8 weeks
Title
The change of creatinine of blood
Description
Venous blood was sampled to measure creatinine
Time Frame
Change from Baseline creatinine at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Hua Liang
Organizational Affiliation
Chia Nan University of Pharmacy ＆ Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chia Nan University of Pharmacy & Science
City
Tainan City
ZIP/Postal Code
71710
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Investigation of the Efficacies of Multi Berries Juice on Anti Oxidant Effect and Improvement of Skin Conditions
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