UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification test of improvements in skin condition by intake of amla extract and fish collagen peptide.
Title of the study (Brief title)	Improvements in skin condition by intake of amla extract and fish collagen peptide.
Region	Japan

Condition
Condition	Healthy female
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate of the effects of amla extract and fish collagen peptide on skin condition.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Collagen density in derma (0w, 8w)
Key secondary outcomes	Moisture content of the stratum corneum (0w, 8w). The image analysis of the skin surface (0w, 8w). Oxidative stress markers (8-OHdG and IPs) (0w, 8w). Urine metabolite (0w, 8w). Glycation markers (0w, 8w). Improvement of symptoms (0w, 4w, 8w).

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of test food containing amla extract and collagen peptide in 8 weeks.
Interventions/Control_2
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	32 years-old <=
Age-upper limit	58 years-old >=
Gender	Female
Key inclusion criteria	(1)Healthy females between the ages of 20 and 65. (2)Individuals whose written informed consent has been obtained.
Key exclusion criteria	(1)Subjects with allergies to raw materials for test foods. (2)Subjects who take healthy foods obtaine amla extract and fish collagen peptide. (3)Subjects who routinely take healthy foods. (4)Subjects who has a factor (diseases such as atopic dermatitis and hives, inflammation, eczema, trauma, breakouts, warts, blemishes, etc. or traces) influencing the test at evaluation site. (5)Subjects with experience in cosmetic medicine (Botox injections, hyaluronic acid, collagen infusion, photofacial, etc.) at the evaluation site or who are expected to undergo the test period. (6)Subjects who has received a special skin care treatment (beauty salon, esthetic, etc.) for the evaluation site within the past four weeks or is expected to undergo during the examination period. (7)Subjects who changed the basic cosmetics and sunscreen material used for the evaluation site within the past four weeks, or newly started using it. (8)Night Shift and day and night shift workers. (9)Subjects who has received a treatment (hormone replacement therapy, drug therapy, exercise therapy, diet, etc.) at a medical institution for the treatment or prevention of disease and is deemed to be in need of treatment at the time of consent acquisition. (10)Glucose metabolism, lipid metabolism, liver function, renal function, heart, cardiovascular, respiratory tract, endocrine system, immune system, subjects with a history of serious diseases or psychiatric disorders of the nervous system. (11)subjects who has dependence of drug and alcohol. (12)Subjects with allergies to cosmetics or foods. (13)Pregnant women, those who may be pregnant, lactating women, or women who hope to become pregnant during the study period. (14)Subjects who has participated in other human studies within the past four weeks, or subjects who plan to participate in other human studies during the planned period of the study. (15)Subjects who were considered inappropriate for the study by an investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	Sumio Kondo
Organization	Medical corporation Kenshokai, Fukushima healthcare center
Division name	Internal medicine
Address	2-12-16, Tamagawa, Fukushima-ku, Osaka
TEL	06-6882-1130
Email	s.kondo@drc-web.co.jp

Public contact
Name of contact person	Taishi Koyama
Organization	Miki Corporation
Division name	Institure for Health science
Address	12-4, Naruohama 3, Nishinomiya, Hyogo
TEL	0798-43-1870
Homepage URL
Email	koyama@mikiprune.co.jp

Sponsor
Institute	Miki Corporation
Institute
Department

Funding Source
Organization	Miki Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 09 Month 15 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 11 Month 19 Day
Last modified on	2019 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039833