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
About this trial
This is an interventional supportive care trial for Skin Manifestations
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
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
NCT ID
NCT03505684
First Posted
April 13, 2018
Last Updated
August 27, 2018
Sponsor
Pusan National University Yangsan Hospital
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
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