search
Back to results

Effect of Oral Collagen Tripeptide on Skin Moisture and Wrinkles in Adult Women

Primary Purpose

Skin Manifestations, Skin Wrinkling

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CTP
placebo (starch)
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Skin Manifestations

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

- > = 4 of Tewameter

Exclusion Criteria:

  • Within the last 6 months, took skin surgery including cosmetic purpose
  • Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more
  • Creatinine levels: more than twice the normal upper limit
  • AST (GOT) or ALT (GPT) levels: more than twice the normal upper limit
  • Uncontrolled hypertension
  • sun allergy or sensitive skin
  • functional cosmetics that affect dermal moistures and wrinkles within the last 3 months.
  • If you have participated or are planning to participate in another clinical trial within the past month
  • Alcohol abuser
  • If they are pregnant or lactating or have a pregnancy plan during the clinical trial Those with allergic reactions to the constituent food
  • Any person deemed inappropriate by the researcher for other reasons

Sites / Locations

  • Integrated Research Institute for Natural Ingredients and Functional Foods

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CTP group

Control group

Arm Description

1,000 mg of collagen tripeptide (CTP) was orally administered per day for 12 weeks.

1,000 mg of placebo (starch) was orally administered per day for 12 weeks

Outcomes

Primary Outcome Measures

changes in Transepidermal Waterloss by Tewameter
comparison between baseline, after 6 weeks, and after 12 weeks

Secondary Outcome Measures

changes in skin wrinkling indices by Visiometer
comparison between baseline, after 6 weeks, and after 12 weeks
skin elasticity by Cutometer
comparison between baseline, after 6 weeks, and after 12 weeks
changes in hydration level of the skin surface by Corneometer
comparison between baseline, after 6 weeks, and after 12 weeks

Full Information

First Posted
April 13, 2018
Last Updated
August 27, 2018
Sponsor
Pusan National University Yangsan Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03505684
Brief Title
Effect of Oral Collagen Tripeptide on Skin Moisture and Wrinkles in Adult Women
Official Title
Effect of Oral Collagen Tripeptide on Skin Moisture and Wrinkles in Adult Women
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 24, 2017 (Actual)
Primary Completion Date
July 15, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of collagen tripeptides derived from fish on dermal moistures and wrinkles body fat reduction in participants
Detailed Description
The aim is to investigate the effect of oral ingestion of collagen tripeptides derived from fish on dermal moistures and wrinkles body fat reduction in participants by a randomized, double-blind, and control-group study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Manifestations, Skin Wrinkling

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CTP group
Arm Type
Experimental
Arm Description
1,000 mg of collagen tripeptide (CTP) was orally administered per day for 12 weeks.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
1,000 mg of placebo (starch) was orally administered per day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
CTP
Intervention Description
1,000 mg of CTP was orally administered per day for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo (starch)
Intervention Description
placebo (starch)
Primary Outcome Measure Information:
Title
changes in Transepidermal Waterloss by Tewameter
Description
comparison between baseline, after 6 weeks, and after 12 weeks
Time Frame
baseline, after 6 weeks, and after 12 weeks
Secondary Outcome Measure Information:
Title
changes in skin wrinkling indices by Visiometer
Description
comparison between baseline, after 6 weeks, and after 12 weeks
Time Frame
baseline, after 6 weeks, and after 12 weeks
Title
skin elasticity by Cutometer
Description
comparison between baseline, after 6 weeks, and after 12 weeks
Time Frame
baseline, after 6 weeks, and after 12 weeks
Title
changes in hydration level of the skin surface by Corneometer
Description
comparison between baseline, after 6 weeks, and after 12 weeks
Time Frame
baseline, after 6 weeks, and after 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - > = 4 of Tewameter Exclusion Criteria: Within the last 6 months, took skin surgery including cosmetic purpose Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more Creatinine levels: more than twice the normal upper limit AST (GOT) or ALT (GPT) levels: more than twice the normal upper limit Uncontrolled hypertension sun allergy or sensitive skin functional cosmetics that affect dermal moistures and wrinkles within the last 3 months. If you have participated or are planning to participate in another clinical trial within the past month Alcohol abuser If they are pregnant or lactating or have a pregnancy plan during the clinical trial Those with allergic reactions to the constituent food Any person deemed inappropriate by the researcher for other reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD
Organizational Affiliation
Integrated Research Institute for Natural Ingredients and Functional Foods
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrated Research Institute for Natural Ingredients and Functional Foods
City
Yangsan
ZIP/Postal Code
50612
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33521019
Citation
Tak YJ, Shin DK, Kim AH, Kim JI, Lee YL, Ko HC, Kim YW, Lee SY. Effect of Collagen Tripeptide and Adjusting for Climate Change on Skin Hydration in Middle-Aged Women: A Randomized, Double-Blind, Placebo-Controlled Trial. Front Med (Lausanne). 2021 Jan 11;7:608903. doi: 10.3389/fmed.2020.608903. eCollection 2020.
Results Reference
derived

Learn more about this trial

Effect of Oral Collagen Tripeptide on Skin Moisture and Wrinkles in Adult Women

We'll reach out to this number within 24 hrs