UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of components in brown algae on prevention of life style related diseases, a randomized controlled trial.
Title of the study (Brief title)	The effect of components in brown algae on prevention of life style related diseases.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Anti-diabetic effect
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	HbA1c value on 8 weeks after intervention
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of capsule including component in brown algae 1 capsule per day, 8 weeks
Interventions/Control_2	Intake of capsule without component in brown algae 1 capsule per day, 8 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Adults with 5.4-6.4% of HbA1c value
Key exclusion criteria	Some one who has been diagnosed diabetes or during treatment of diabetes. Some one who has allergy for seaweed. Some one who is pregnant, breastfeeding or possibly pregnant.
Target sample size	120

Research contact person
Name of lead principal investigator	Nana Mikami
Organization	Sapporo Medical University
Division name	School of Medicine
Address	South-1, West-17, Chuo-ku, Sapporo, Hokkaido
TEL	011-611-2111
Email	mikami7@sapmed.ac.jp

Public contact
Name of contact person	Nana Mikami
Organization	Sapporo Medical University
Division name	School of Medicine
Address	South-1, West-17, Chuo-ku, Sapporo, Hokkaido
TEL	011-611-2111
Homepage URL
Email	mikami7@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical Unversity
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	MEXT
Organization
Division
Category of Funding 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	2015 Year 12 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 21 Day
Anticipated trial start date	2015 Year 07 Month 17 Day
Last follow-up date	2015 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete	2016 Year 03 Month 18 Day
Date analysis concluded

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

Management information
Registered date	2015 Year 12 Month 01 Day
Last modified on	2016 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021830