Investigation of the Efficacies of Multi Berries Juice on Anti Oxidant Effect and Improvement of Skin Conditions

To assess multi berries juice on anti-oxidant effect and skin condition improvement

Study Overview

• Status: Completed
• Conditions: Skin Condition; Anti Oxidative Stress
• Intervention / Treatment: Dietary supplement: Placebo drink; Dietary supplement: multi berries juice

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo drink	Dietary supplement: Placebo drink; Blank
Experimental: multi berries juice	Dietary supplement: multi berries juice; Testing product; Other Names: Sei Bella™ Pure Essence Whitening Multi-Berries Drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of skin L* value	Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100	Change from Baseline L* value at 8 weeks
The change of skin UV spots	VISIA Complexion Analysis System was utilized to measure skin UV spots. Units: arbitrary units	Change from Baseline skin UV spots at 8 weeks
The change of skin melanin index	Soft Plus was utilized to measure skin melanin index. Units: arbitrary units	Change from Baseline skin melanin index at 8 weeks
The change of blood SOD content	Venous blood was sampled to measure concentrations of SOD	Change from Baseline SOD content at 8 weeks
The change of blood total antioxidant capacity (TAC)	Venous blood was sampled to measure concentrations of TAC	Change from Baseline TAC at 8 weeks
The change of skin spots	VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units	Change from Baseline skin spots at 8 weeks
The change of skin brown spots	VISIA Complexion Analysis System was utilized to measure skin brown spots. Units: arbitrary units	Change from Baseline skin brown spots at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of skin moisture	Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120	Change from Baseline skin moisture at 4 weeks
The change of skin wrinkles	VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units	Change from Baseline skin wrinkles at 8 weeks
The change of skin texture	VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units	Change from Baseline skin texture at 8 weeks
The change of skin pores	VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units	Change from Baseline skin pores at 8 weeks
The change of skin a* value	Chroma Meter MM500 was utilized to measure skin a* value. Units: arbitrary units	Change from Baseline a* value at 8 weeks
The change of skin elasticity	Soft Plus was utilized to measure skin elasticity. Units: arbitrary units	Change from Baseline skin elasticity at 8 weeks
The change of skin collagen density	DermaLab® Series SkinLab Combo was utilized to measure skin collagen density. Units: arbitrary units	Change from Baseline skin collagen density at 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of total cholesterol of blood	Venous blood was sampled to measure total cholesterol	Change from Baseline total cholesterol at 8 weeks
The change of triglyceride of blood	Venous blood was sampled to measure triglyceride	Change from Baseline triglyceride at 8 weeks
The change of SGOT of blood	Venous blood was sampled to measure SGOT	Change from Baseline SGOT at 8 weeks
The change of SGPT of blood	Venous blood was sampled to measure SGPT	Change from Baseline SGPT at 8 weeks
The change of BUN of blood	Venous blood was sampled to measure BUN	Change from Baseline BUN at 8 weeks
The change of uric acid of blood	Venous blood was sampled to measure uric acid	Change from Baseline uric acid at 8 weeks
The change of creatinine of blood	Venous blood was sampled to measure creatinine	Change from Baseline creatinine at 8 weeks

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Chia-Hua Liang, Chia Nan University of Pharmacy & Science

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): February 25, 2021

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Skin Diseases
• Other Study ID Numbers: 20-082-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No