UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the anti-glycation effect and skin protection effect by a supplement containing brown algae extract powder. (A randomized,Double-blind,Placebo-controlled, Parallel group study)
Acronym	Evaluation of the anti-glycation effect and skin protection effect by a supplement containing brown algae extract powder.
Scientific Title	Evaluation of the anti-glycation effect and skin protection effect by a supplement containing brown algae extract powder. (A randomized,Double-blind,Placebo-controlled, Parallel group study)
Scientific Title:Acronym	Evaluation of the anti-glycation effect and skin protection effect by a supplement containing brown algae extract powder.
Region	Japan

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

Objectives
Narrative objectives1	To study the effect of ingestion of the test food on the skin damage and glycation stress caused by UV rays.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood AGEs(pentosidine) Minimal erythema dose(MED)
Key secondary outcomes	Skin image analysis by VISIA

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	once a day for eight weeks
Interventions/Control_2	Placebo capsule once a day for eight weeks
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	65 years-old >
Gender	Female
Key inclusion criteria	1) Japanese female aged between 20 and 65 at the time of informed consent. 2) Subjects who can come on the designated inspection day and can be inspected. 3) Subjects who can make self-judgment and are voluntarily giving written informed consent. 4) Subjects who have less activity in the sunlight for a long time in dairy life. 5) Subjects who have no history of a thyroid disease.
Key exclusion criteria	1) Subjects who have serious medical history or have history of digestive surgery (except for appendicitis). 2) Subjects who have diseases that affect test and safety. 3) Subjects who consume medicinal product, health food or Food for Specified Health Uses(FOSHU) which may influence the outcome of the study. 4) Subjects who have allergy for test foods. 5) Subjects who have chronic dermatitis or atopic dermatitis. 6) Subjects who hope to be pregnant during the test, or who are pregnant, breastfeeding. 7) Subjects who had participated in other clinical trials within a month or will participate in other clinical trials during this study period. 8) Subjects who are judged as unsuitable for the study by the investigator with other reasons.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Mitsuhiro Middle name Last name Azuma
Organization	Kaigen Pharma Co.,Ltd.
Division name	Produce Planning Dept.
Zip code	130-0011
Address	4-25-14 Ishihara,Sumida-ku,Tokyo,Japan
TEL	03-5819-2815
Email	m_azuma@kaigen-pharma.co.jp

Public contact
Name of contact person	1st name Naoto Middle name Last name Takebe
Organization	Kaigen Pharma Co.,Ltd.
Division name	Produce Planning Dept.
Zip code	130-0011
Address	4-25-14 Ishihara,Sumida-ku,Tokyo,Japan
TEL	03-5819-2815
Homepage URL
Email	n_takebe@kaigen-pharma.co.jp

Sponsor
Institute	Kaigen Pharma Co.,Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Medical corporation Koizumi dermatology clinic Ethics Review Board
Address	27-1-1,Minami 1-Jonishi,Chuo-ku,Sapporo-shi,Hokkaido
Tel	011-522-6888
Email	info@mediks.jp

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	医療法人社団 薬善会 つくば国際臨床薬理クリニック（茨城県）/Yakuzenkai Medical Corporation Tsukuba International Clinical Pharmacology Clinic(Ibaraki,Japan)

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 15 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	42
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	2021 Year 05 Month 25 Day
Date of IRB	2021 Year 05 Month 26 Day
Anticipated trial start date	2021 Year 06 Month 14 Day
Last follow-up date	2021 Year 10 Month 31 Day
Date of closure to data entry	2021 Year 11 Month 15 Day
Date trial data considered complete	2021 Year 11 Month 22 Day
Date analysis concluded	2022 Year 01 Month 11 Day

Other
Other related information

Management information
Registered date	2021 Year 06 Month 14 Day
Last modified on	2022 Year 02 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050827