UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Suppression effects on body weight and fat of calcium alginate in healthy adults
Title of the study (Brief title)	Diet effect of calcium alginate
Region	Japan

Condition
Condition	metabolic syndrome
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will investigate the effect on body weight and fat suppression of calcium alginate using healthy adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The effect on body weight (Measuring point:every week)
Key secondary outcomes	The effect on body fat (Measuring point: every week)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	Test substance-treated group Total 4g per day ( in three doses ) for five weeks
Interventions/Control_2	Placebo group Total 4g per day ( in three doses ) for five 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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Body Mass Index is 23 or more but less than 30
Key exclusion criteria	Those who felt this study was inconvenient to everyday life.
Target sample size	10

Research contact person
Name of lead principal investigator	Takuo Ogihara
Organization	Takasaki University of Health and Welfare
Division name	Graduate School, Department of Pharmacology
Address	60 Nakaorui-machi, Takasaki-shi, Gunma, Japan
TEL	027-352-1180
Email	togihara@takasaki-u.ac.jp

Public contact
Name of contact person	Yoko Idota
Organization	Takasaki University of Health and Welfare
Division name	Faculty of Pharmacy
Address	60 Nakaorui-machi, Takasaki-shi, Gunma, Japan
TEL	027-352-1180
Homepage URL
Email	y-idota@takasaki-u.ac.jp

Sponsor
Institute	Takasaki University of Health and Welfare
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)

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 11 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 25 Day
Anticipated trial start date	2015 Year 11 Month 06 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	2015 Year 11 Month 06 Day
Last modified on	2017 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022713