NCT06194487

Brief Summary

To assess MAXI Collagen drink on skin condition improvement

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

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

October 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2023

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2024

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

December 22, 2023

Last Update Submit

May 3, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • The change of skin collagen density

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

    Day 0, Day 7, Day 28

  • The change of skin elasticity

    Cutometer® Dual MPA 580 was utilized to measure skin elasticity. Units: arbitrary units

    Day 0, Day 7, Day 28

  • The change of skin moisture

    Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120

    Day 0, Day 7, Day 28

  • The change of skin texture

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

    Day 0, Day 7, Day 28

Secondary Outcomes (5)

  • The change of transepidermal water loss (TEWL)

    Day 0, Day 7, Day 28

  • The change of skin wrinkles

    Day 0, Day 7, Day 28

  • The change of skin pores

    Day 0, Day 7, Day 28

  • The change of skin colour

    Day 0, Day 7, Day 28

  • The change of self-assessment skin condition

    Day 0, Day 7, Day 28

Other Outcomes (3)

  • The change of liver function biomarkers (GOT, GPT) of blood

    Day 0, Day 28

  • The change of renal function biomarkers (creatinine, BUN) of blood

    Day 0, Day 28

  • The change of fasting blood glucose

    Day 0, Day 28

Study Arms (3)

Placebo drink

PLACEBO COMPARATOR

consume 1 bottle (50mL) per day

Dietary Supplement: Placebo drink

MAXI Collagen drink

EXPERIMENTAL

consume 1 bottle (50mL) per day

Dietary Supplement: MAXI Collagen drink

Normal fish collagen drink

ACTIVE COMPARATOR

consume 1 bottle (50mL) per day

Dietary Supplement: Normal fish collagen drink

Interventions

Placebo drinkDIETARY_SUPPLEMENT

consume 1 bottle (50mL) per day

Placebo drink
MAXI Collagen drinkDIETARY_SUPPLEMENT

consume 1 bottle (50mL) per day

MAXI Collagen drink
Normal fish collagen drinkDIETARY_SUPPLEMENT

consume 1 bottle (50mL) per day

Normal fish collagen drink

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults aged 35-65 years old

You may not qualify if:

  • Subject with skin surface damage larger than $50 coin area.
  • Subject who had skin allergies caused by diet or undrwent cosmetic or medical treatment within 6 months.
  • Subject who is a vegetarian and allergic to seafood, alcohol or listed ingredients in the product.
  • Students who are currently taking courses taught by the principal investigator of this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Applied Cosmetology, Hungkuang University

Taichung, 433304, Taiwan

Location

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

  • Tzu Fang Hsu

    Department of Applied Cosmetology, Hungkuang University

    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

December 22, 2023

First Posted

January 8, 2024

Study Start

October 1, 2023

Primary Completion

December 29, 2023

Study Completion

January 26, 2024

Last Updated

May 6, 2024

Record last verified: 2024-05

Locations