Efficacy Testing of Collagen Drink on Skin Beauty and Sleep Aid

NCT05182814 | Completed

• 1 other identifier: 21-102-B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To assess Collagen Drink on skin condition and sleep quality improvement

Conditions

Skin Condition; Sleep Disturbance

Outcome Measures

Primary Outcomes (9)

• 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 collagen density

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

  Change from Baseline skin collagen density at 8 weeks

• The change of skin elasticity

  Cutometer® MPA580 was utilized to measure skin elasticity. Units: arbitrary units

  Change from Baseline skin elasticity 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 sleep quality

  Self-assessment questionnaire was utilized to survey sleep quality.

  Change from Baseline sleep quality at 8 weeks

• The change of AGEs of blood

  Venous blood was sampled to measure AGEs

  Change from Baseline AGEs at 8 weeks

• The change of TIMP-1 of blood

  Venous blood was sampled to measure TIMP-1

  Change from Baseline TIMP-1 at 8 weeks

• The change of desmosine of blood

  Venous blood was sampled to measure desmosine

  Change from Baseline desmosine at 8 weeks

Secondary Outcomes (5)

• The change of skin melanin index

  Change from Baseline skin melanin index at 8 weeks

• The change of skin pores

  Change from Baseline skin pores at 8 weeks

• The change of skin a* value

  Change from Baseline skin a* value at 8 weeks

• The change of skin hydration

  Change from Baseline skin hydration at 8 weeks

• The change of transepidermal water loss

  Change from Baseline transepidermal water loss at 8 weeks

Study Arms (2)

Placebo drink

PLACEBO COMPARATOR

Dietary Supplement: Placebo drink

Collagen drink

EXPERIMENTAL

Dietary Supplement: Collagen Juice Drink

Interventions

Placebo drink DIETARY_SUPPLEMENT

Blank

Placebo drink

Collagen Juice Drink DIETARY_SUPPLEMENT

Testing product

Also known as: LISAVEI® Collagen Juice Drink

Collagen drink

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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
• Constant drug use
• Received facial laser therapy, chemical peeling or UV overexposure (\>3 hours everyday) in the past 4 weeks.
• Students taught by the PI

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

Chia Nan University of Pharmacy ＆ Science

Tainan, 71710, Taiwan

Location

MeSH Terms

Conditions

Skin Diseases; Parasomnias

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

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: January 4, 2022
• First Posted: January 10, 2022
• Study Start: November 10, 2021
• Primary Completion: February 28, 2022
• Study Completion: April 30, 2022
• Last Updated: June 13, 2022

Record last verified: 2022-03

Locations

TW (1)