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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038725
Receipt No. R000044131
Scientific Title A randomized, double-blind, placebo-controlled, parallel-group study on the effect of food containing fucose on obesity and constipation.
Date of disclosure of the study information 2019/12/02
Last modified on 2019/11/29

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Basic information
Public title A randomized, double-blind, placebo-controlled, parallel-group study on the effect of food containing fucose on obesity and constipation.
Acronym Study on the effect of food containing fucose on obesity and constipation.
Scientific Title A randomized, double-blind, placebo-controlled, parallel-group study on the effect of food containing fucose on obesity and constipation.
Scientific Title:Acronym Study on the effect of food containing fucose on obesity and constipation.
Region
Japan

Condition
Condition Healthy and overweight adult subjects between 23 or more and less than 30 in body mass index (BMI)
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of food containing fucose on obesity and constipation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Visceral fat area
*Assess the fat area by X-ray CT
Key secondary outcomes 1. Subcutaneous fat area
2. Total fat area
3. Visceral fat area
4. Subcutaneous fat area
5. Total fat area
6. Waist and Hip circumference
7. Body weight
8. Defecation frequency
9. Bristol stool scale

*1-2 Assess these by X-ray CT
*3-5 Assess these by Bioelectrical impedance analysis

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
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of supplement containing fucose for 12 weeks.
Interventions/Control_2 Ingestion of placebo without fucose 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
65 years-old >
Gender Female
Key inclusion criteria 1. Healthy males and females aged 20 to 64 years old
2. Subjects who are between 23 kg/m2 or more and less than 30 kg/m2 in BMI
3. Subjects with subjective symptoms of chronic constipation
4. Subjects who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria 1. Subjects who use medications affecting obesity and constipation
2. Subjects who cannot stop using supplements and/or functional foods affecting obesity and constipation
3. Subjects who are under treatment or have a history of disease e.g., serious liver disease, heart disease, respiratory insufficiency, endocrine disorder, metabolic diseases or food allergy
4. Subjects who have under treatment or a history of drug addiction and/or alcoholism
5. Subjects who have implanted metal in the abdominal area, as detected by computerized tomography
6. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
7. Subjects who have been diagnosed as familial hyperlipidemia
8. Subjects who has food allergy
9. Subjects who are participating or planning to participate in other clinical studies to examine effects of food, medicine or cosmetics
10. Subjects who are planning to become pregnant during the study or are pregnant or lactating
11. Subjects who are judged as unsuitable for the study by the investigator for other reasons
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Satoru
Middle name
Last name Suzuki
Organization Shinagawa Season Terrace Health Care Clinic
Division name General Manager of Medical Examination Department
Zip code 108-0075
Address 1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
TEL 03-3452-3381
Email satoru_suzuki@sempos.or.jp

Public contact
Name of contact person
1st name Eiji
Middle name
Last name Yoshikawa
Organization KSO Corporation
Division name Sales department
Zip code 105-0023
Address 1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Yaizu Suisankagaku Industry Co., Ltd.

IRB Contact (For public release)
Organization Shinagawa Season Terrace Health Care Clinic
Address 1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
Tel 03-3452-3381
Email tomohiro_kogo@sempos.or.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

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 02 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
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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 06 Day
Last follow-up date
2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 29 Day
Last modified on
2019 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044131

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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