UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of food intake on insulin resistance and obesity
Title of the study (Brief title)	The effects of Onsen alga powder intake on insulin resistance and obesity
Region	Japan

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

Objectives
Narrative objectives1	A placebo controlled double blind clinical trial to evaluate of the effects of Onsen alga on insulin resistance and obesity
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Not applicable
Key secondary outcomes	Measurement of waist circumference, measurements of height and weight, measurement of vital sign, blood examination, findings and evaluations of a doctor, and a health state diary From the baseline to Week 12

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	Treatment
Type of intervention	Food
Interventions/Control_1	Taking in 5 capsules of test sample after breakfast or in the morning every day for 12 weeks
Interventions/Control_2	Taking in 5 capsules of placebo sample after breakfast or in the morning every day for 12 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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Age: from 20 to 64 years old 2) BMI: 25 or more but less than 30
Key exclusion criteria	1) Those who have more than 2.5 times of reference value of gamma-GT (gamma-GTP) 2) Those who have more than 2.5 times of reference value of AST (GOT) 3) Those who have more than 2.5 times of reference value of ALT (GPT) 4) Those who have more than 6.5 % of HbA1c value 5) Those who are taking a medicine that may influence test results. e.g. medicine that decreases the blood sugar level, etc. 6) Those who have been on a daily basis taken a health food(s) that may influence test results. e.g. health food that may decrease the blood sugar level, etc. 7) Women who are in pregnancy or may become pregnant, or are nursing 8) Those who are "Alcoholism" 9) Those who may have an allergy to the ingredient of the test sample 10) Participants in other clinical trial 11) Those who have a medical history of severe hepatic disorders, renal disorders, or cardiovascular disease 12) Those who have hepatitis or its previous history 13) Those who have severe anemia 14) Those who have hypertension 15) Those who have hyperlipidemia 16) Those who were judged inappropriate to join the study by doctor in charge
Target sample size	30

Research contact person
Name of lead principal investigator	Takashi Koikeda
Organization	Shiba Palace Clinic
Division name	Chair
Address	6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL	+81-3-5408-1590
Email	jimukyoku@mail.souken-r.com

Public contact
Name of contact person	Ko Masuda
Organization	SOUKEN Co., Ltd
Division name	Management Division
Address	3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL	+81-3-5408-1555
Homepage URL
Email	k_masuda@mail.souken-r.com

Sponsor
Institute	SOUKEN Co., Ltd.
Institute
Department

Funding Source
Organization	METI(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Saravio Cosmetics Ltd.
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	芝パレスクリニック　(東京都) 　　　　　 Shiba Palace Clinic (Tokyo) 株式会社SOUKEN 　　　　 　　　 SOUKEN Co. Ltd.

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 24 Day
Anticipated trial start date	2017 Year 10 Month 18 Day
Last follow-up date	2018 Year 01 Month 10 Day
Date of closure to data entry	2018 Year 02 Month 02 Day
Date trial data considered complete	2018 Year 02 Month 08 Day
Date analysis concluded	2018 Year 02 Month 23 Day

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

Management information
Registered date	2018 Year 03 Month 05 Day
Last modified on	2018 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036055