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

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ClinicalTrials.gov Identifier: NCT03505684
Recruitment Status : Completed
First Posted : April 23, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Sang Yeoup Lee, Pusan National University Yangsan Hospital

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

Condition or disease Intervention/treatment Phase
Skin Manifestations Skin Wrinkling Dietary Supplement: CTP Dietary Supplement: placebo (starch) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of Oral Collagen Tripeptide on Skin Moisture and Wrinkles in Adult Women
Actual Study Start Date : December 24, 2017
Actual Primary Completion Date : July 15, 2018
Actual Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. skin elasticity by Cutometer [ Time Frame: baseline, after 6 weeks, and after 12 weeks ]
    comparison between baseline, after 6 weeks, and after 12 weeks

  3. 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



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505684


Locations
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Korea, Republic of
Integrated Research Institute for Natural Ingredients and Functional Foods
Yangsan, Korea, Republic of, 50612
Sponsors and Collaborators
Pusan National University Yangsan Hospital
Investigators
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Principal Investigator: Sang Yeoup Lee, MD Integrated Research Institute for Natural Ingredients and Functional Foods

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Responsible Party: Sang Yeoup Lee, Principal Investigator, Professor, Head of Integrated Research Institute for Natural Ingredients and Functional Foods (IRINIF), Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT03505684     History of Changes
Other Study ID Numbers: 02-2017-033
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Skin Manifestations
Signs and Symptoms