NCT04878523

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

May 6, 2021

Last Update Submit

May 6, 2021

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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 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 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 Outcomes (7)

  • The change of skin moisture

    Change from Baseline skin moisture at 4 weeks

  • The change of skin a* value

    Change from Baseline a* value at 8 weeks

  • The change of skin elasticity

    Change from Baseline skin elasticity at 8 weeks

  • The change of skin wrinkles

    Change from Baseline skin wrinkles at 8 weeks

  • The change of skin texture

    Change from Baseline skin texture at 8 weeks

  • +2 more secondary outcomes

Other Outcomes (7)

  • The change of total cholesterol of blood

    Change from Baseline total cholesterol at 8 weeks

  • The change of triglyceride of blood

    Change from Baseline triglyceride at 8 weeks

  • The change of SGOT of blood

    Change from Baseline SGOT at 8 weeks

  • +4 more other outcomes

Study Arms (2)

Placebo drink

PLACEBO COMPARATOR
Dietary Supplement: Placebo drink

multi berries juice

EXPERIMENTAL
Dietary Supplement: multi berries juice

Interventions

multi berries juiceDIETARY_SUPPLEMENT

Testing product

Also known as: Sei Bella™ Pure Essence Whitening Multi-Berries Drink
multi berries juice
Placebo drinkDIETARY_SUPPLEMENT

Blank

Placebo drink

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults aged above 20 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chia Nan University of Pharmacy & Science

Tainan, 71710, Taiwan

Location

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

  • Chia-Hua Liang

    Chia Nan University of Pharmacy & Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 7, 2021

Study Start

November 9, 2020

Primary Completion

January 15, 2021

Study Completion

February 25, 2021

Last Updated

May 7, 2021

Record last verified: 2021-05

Locations