UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of elastin peptide from horse on skin elasticity and body shape
Acronym	Effects of consumption of elastin peptide from horse on skin elasticity and body shape
Scientific Title	Effects of consumption of elastin peptide from horse on skin elasticity and body shape: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym	Effects of consumption of elastin peptide from horse on skin elasticity and body shape
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of consumption of the test food on body shapes such as face, bust, and hips.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Viscoelasticity of the face * Assess the measured value at screening (before consumption) and at 4, and 8 weeks after consumption and calculate the amount of change.
Key secondary outcomes	1. Viscoelasticity of the bust 2. Viscoelasticity of the hip 3. Bust circumference (top and under) 4. The difference circumference between the top bust and the under bust 5. Bust size 6. The height from the ground to top of the bust 7. Hip circumference 8. The height from the ground to top of the hip 9. Waist circumference 10. Waist-to-hip ratio 11. Change of the bust size 12. Intensity 13. Skin Thickness 14. Low Echogenic Band (LEB) 15. Subjective symptoms (The Likert scale method) 16. Facial skin brightness 17. Numbers of facial skin pigmentations [small size, large size (LV 1), large size (LV 2), large size (LV 3)] 18. Areas of facial skin pigmentations [small size, large size (LV 1), large size (LV 2), large size (LV 3)] 19. Numbers of facial pores 20. Numbers of noticeable facial pores 21. Numbers of facial pores with prominent opening 22. Numbers of facial pores with prominent darkening 23. Numbers of facial wrinkles 24. Total length of facial wrinkles 25. Total area of facial wrinkles 26. Facial skin texture 27. Numbers of facial redness (LV 1, LV 2 and LV 3) 28. Total area of facial redness (LV 1, LV 2 and LV 3) 29. Facial skin moisture *1-14, 16-29 Assess the measured value at screening (before consumption) and at 4, and 8 weeks after consumption and calculate the amount of change. *15 Assess the measured value at screening (before consumption) and at 4, and 8 weeks after consumption. *11 Measure the length between the center of clavicle and each breast by 3D camera. *12-14 Measure the dermal condition by DermaLab. *16-29 Measure the skin condition by skin analysis device.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 8 weeks Test food: Tablets containing elastin peptide from horse Administration: Take 2 tablets a day after lunch until before bedtime * If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2	Duration: 8 weeks Test food: Placebo tablets Administration: Take 2 tablets a day after lunch until before bedtime * If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1. Healthy Japanese adult women 2. Subjects who are anxious about facial skin elasticity 3. Subjects who are judged as eligible to participate in the study by the physician 4. Within the subjects who met 1st to 3rd inclusion criteria, select subjects with relatively low score in viscoelasticity of the face.
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily. 5. Subjects who have been diagnosed with atopic dermatitis 6. Subjects who use any other products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, and face masks, skin lotions, milky lotions, and sunscreen, for daily skincare. 7. Subjects who regularly receive skin care treatment (massages etc.) or use beauty products (facial equipment etc.) 8. Subjects who have got cosmetic surgery 9. Subjects who are currently taking medications (including herbal medicines) and supplements 10. Subjects who work late-night shift and the erratic lifestyle 11. Subjects who are allergic to medicines and/or the test food related products. Particularly allergic to horse. 12. Subjects who are pregnant, lactation, or planning to become pregnant 13. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period 14. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	BIOCON (JAPAN) LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hiroo Dermatology Clinic & Mentors inc. Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	info@takara-clinic.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	広尾皮フ科クリニック (東京都) Hiroo Dermatology Clinic & Mentors inc. (Tokyo, Japan) 医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2019 Year 05 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	32
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 05 Month 13 Day
Date of IRB	2019 Year 05 Month 13 Day
Anticipated trial start date	2019 Year 05 Month 22 Day
Last follow-up date	2019 Year 12 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 21 Day
Last modified on	2022 Year 08 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041936