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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032738
Receipt No. R000037335
Scientific Title Effect of supplement on VFA reduction. - A randomized, double-blind, placebo-controlled, parallel-group clinical trial -
Date of disclosure of the study information 2018/06/30
Last modified on 2019/05/27

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Basic information
Public title Effect of supplement on VFA reduction. - A randomized, double-blind, placebo-controlled, parallel-group clinical trial -
Acronym Effect of supplement on VFA reduction.
Scientific Title Effect of supplement on VFA reduction. - A randomized, double-blind, placebo-controlled, parallel-group clinical trial -
Scientific Title:Acronym Effect of supplement on VFA reduction.
Region
Japan

Condition
Condition none
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate the effect of ingestion of supplement on visceral fat area.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visceral Fat Area(VFA)
Key secondary outcomes Body Weight, BMI, Subcutaneous fat area(SFA), Total fat area(TFA), Stool frequency, Bristol stool from scale(BSFS)

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
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of supplement for twenty-four weeks.
Interventions/Control_2 Ingestion of placebo for twenty-four 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
50 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1) Japanese males and females aged 50 to 70 years.
2)Subjects who are evaluating body mass index 25 to 30.
3) Subjects who are feeling disorder of stool form including chronic hard stool or loose stool.
4) Subjects who received a sufficient explanation about the purpose and content of this study and have a consent ability and volunteered to participate in the understanding and can agree to this study participation in writing.
Key exclusion criteria 1) Subjects who use medicine that may influence a bowel movement.
2) Subjects who take health food or dietary supplement that may influence a bowel movement.
3) Subjects who take general food including Bifidbacterium that continue more than three times a week and more than half year.
4) Subjects who take medicine, Kampo preparation or dietary supplement affecting weight reduction.
5) Subjects who have colonic disease within 10 years, but these persons except who polyp or infectious colitis.
6) Subjects who take medical treatment for obesity-related disease that is glucose intolerance, dyslipidemia, hypertension, hyperuricemia, gout, coronary artery disease, cerebral infarction, fatty liver, menstrual abnormality, sleep apnea syndrome・obesity hypoventilation syndrome, orthopedic disease, obesity-related renal disease.
7) Subjects who have severe disorders in liver function or kidney function.
8) Subjects who have history of gastrointestine surgery that is gastrectomy, gastrointestinal suture, enterectomy, etc.
9) Subjects who have allergy to medicine, shrimp, crab, milk or egg.
10) Subjects who can't discontinue dietary supplements for test period.
11) Subjects who are planned to participate in other clinical study.
12) Female with pregnancies, lactating or planning to become pregnant during the study.
13) Subjects whom metal is implanted in a CT scanning part by operation treatment.
14) Subjects whom heart pacemaker or implantable cardiac defibrillator is implanted in own body.
15) Subjects who have extreme constipation or diarrhea.
16) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size 170

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Suzuki
Organization Shinagawa Season Terrace Health Care Clinic
Division name Medical examination and treatment management family chief director
Zip code
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
Middle name
Last name Eiji Yoshikawa
Organization KSO Corporation
Division name Sales department
Zip code
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 FANCL Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 品川シーズンテラス健診クリニック(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 30 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 Completed
Date of protocol fixation
2018 Year 05 Month 21 Day
Date of IRB
2018 Year 05 Month 23 Day
Anticipated trial start date
2018 Year 06 Month 30 Day
Last follow-up date
2018 Year 12 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 28 Day
Last modified on
2019 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037335

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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