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

August 27, 2018 updated by: Sang Yeoup Lee, Pusan National University Yangsan Hospital
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Yangsan, Korea, Republic of, 50612
        • Integrated Research Institute for Natural Ingredients and Functional Foods

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CTP group
1,000 mg of collagen tripeptide (CTP) was orally administered per day for 12 weeks.
Dietary supplement: CTP
1,000 mg of CTP was orally administered per day for 12 weeks.
Placebo Comparator: Control group
1,000 mg of placebo (starch) was orally administered per day for 12 weeks
Dietary supplement: placebo (starch)
placebo (starch)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in Transepidermal Waterloss by Tewameter
Time Frame: baseline, after 6 weeks, and after 12 weeks
comparison between baseline, after 6 weeks, and after 12 weeks
baseline, after 6 weeks, and after 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Yangsan Hospital

Investigators

  • Principal Investigator: Sang Yeoup Lee, MD, Integrated Research Institute for Natural Ingredients and Functional Foods

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2017

Primary Completion (Actual)

July 15, 2018

Study Completion (Actual)

July 30, 2018

Study Registration Dates

First Submitted

April 13, 2018

First Submitted That Met QC Criteria

April 20, 2018

First Posted (Actual)

April 23, 2018

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-2017-033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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