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

• Sponsor: TCI Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04878523
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.5
• Patients Per Site Per Month: 11.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Skin Condition; Anti Oxidative Stress	Dietary Supplement: multi berries juice; Dietary Supplement: Placebo drink	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Investigation of the Efficacies of Multi Berries Juice on Anti Oxidant Effect and Improvement of Skin Conditions
• Actual Study Start Date: Nov 9, 2020
• Actual Primary Completion Date: Jan 15, 2021
• Actual Study Completion Date: Feb 25, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The change of skin UV spots [Change from Baseline skin UV spots at 8 weeks]

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

2. The change of skin melanin index [Change from Baseline skin melanin index at 8 weeks]

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

3. The change of blood SOD content [Change from Baseline SOD content at 8 weeks]

   Venous blood was sampled to measure concentrations of SOD

4. The change of blood total antioxidant capacity (TAC) [Change from Baseline TAC at 8 weeks]

   Venous blood was sampled to measure concentrations of TAC

5. The change of skin L* value [Change from Baseline L* value at 8 weeks]

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

6. The change of skin spots [Change from Baseline skin spots at 8 weeks]

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

7. The change of skin brown spots [Change from Baseline skin brown spots at 8 weeks]

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

Secondary Outcome Measures

1. 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

2. The change of skin a* value [Change from Baseline a* value at 8 weeks]

   Chroma Meter MM500 was utilized to measure skin a* value. Units: arbitrary units

3. The change of skin elasticity [Change from Baseline skin elasticity at 8 weeks]

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

4. The change of skin wrinkles [Change from Baseline skin wrinkles at 8 weeks]

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

5. The change of skin texture [Change from Baseline skin texture at 8 weeks]

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

6. The change of skin pores [Change from Baseline skin pores at 8 weeks]

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

7. The change of skin collagen density [Change from Baseline skin collagen density at 8 weeks]

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

Other Outcome Measures

1. The change of total cholesterol of blood [Change from Baseline total cholesterol at 8 weeks]

   Venous blood was sampled to measure total cholesterol

2. The change of triglyceride of blood [Change from Baseline triglyceride at 8 weeks]

   Venous blood was sampled to measure triglyceride

3. The change of SGOT of blood [Change from Baseline SGOT at 8 weeks]

   Venous blood was sampled to measure SGOT

4. The change of SGPT of blood [Change from Baseline SGPT at 8 weeks]

   Venous blood was sampled to measure SGPT

5. The change of BUN of blood [Change from Baseline BUN at 8 weeks]

   Venous blood was sampled to measure BUN

6. The change of uric acid of blood [Change from Baseline uric acid at 8 weeks]

   Venous blood was sampled to measure uric acid

7. The change of creatinine of blood [Change from Baseline creatinine at 8 weeks]

   Venous blood was sampled to measure creatinine

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

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: NCT04878523
• Other Study ID Numbers: 20-082-B
• First Posted: May 7, 2021
• Last Update Posted: May 7, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Skin Diseases; Disease

Study Results

No Results Posted as of May 7, 2021