NCT03505684

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

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

December 24, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

April 13, 2018

Last Update Submit

August 27, 2018

Conditions

Skin ManifestationsSkin Wrinkling

Outcome Measures

Primary Outcomes (1)

  • changes in Transepidermal Waterloss by Tewameter

    comparison between baseline, after 6 weeks, and after 12 weeks

    baseline, after 6 weeks, and after 12 weeks

Secondary Outcomes (3)

  • changes in skin wrinkling indices by Visiometer

    baseline, after 6 weeks, and after 12 weeks

  • skin elasticity by Cutometer

    baseline, after 6 weeks, and after 12 weeks

  • changes in hydration level of the skin surface by Corneometer

    baseline, after 6 weeks, and after 12 weeks

Study Arms (2)

CTP group

EXPERIMENTAL

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

Dietary Supplement: CTP

Control group

PLACEBO COMPARATOR

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

Dietary Supplement: placebo (starch)

Interventions

CTPDIETARY_SUPPLEMENT

1,000 mg of CTP was orally administered per day for 12 weeks.

CTP group
placebo (starch)DIETARY_SUPPLEMENT

placebo (starch)

Control group

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- \> = 4 of Tewameter

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrated Research Institute for Natural Ingredients and Functional Foods

Yangsan, 50612, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33521019DERIVED

MeSH Terms

Conditions

Skin Manifestations

Interventions

Cytidine Triphosphate

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Sang Yeoup Lee, MD

    Integrated Research Institute for Natural Ingredients and Functional Foods

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Professor, Head of Integrated Research Institute for Natural Ingredients and Functional Foods (IRINIF)

Study Record Dates

First Submitted

April 13, 2018

First Posted

April 23, 2018

Study Start

December 24, 2017

Primary Completion

July 15, 2018

Study Completion

July 30, 2018

Last Updated

August 28, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)