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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026291
Receipt No. R000030198
Scientific Title Examination study on abdominal visceral fat reducing action by functional food intake -Randomized placebo-controlled double-blind parallel group comparison study-
Date of disclosure of the study information 2017/04/07
Last modified on 2017/09/11

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Basic information
Public title Examination study on abdominal visceral fat reducing action by functional food intake
-Randomized placebo-controlled double-blind parallel group comparison study-
Acronym Examination study on abdominal visceral fat reducing action by functional food intake
Scientific Title Examination study on abdominal visceral fat reducing action by functional food intake
-Randomized placebo-controlled double-blind parallel group comparison study-
Scientific Title:Acronym Examination study on abdominal visceral fat reducing action by functional food intake
Region
Japan

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

Objectives
Narrative objectives1 To investigate the effect of intake of functional food for 12 weeks on abdominal fat area reduction and safety in males and females with abdominal obesity aged 20-64
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes <Efficacy>
Abdominal visceral fat area, at 8 and 12 weeks after intake
<Safety>
Side effect incidence
Key secondary outcomes <Efficacy>
Abdominal subcutaneous fat area and abdominal whole fat area, at 8 and 12 weeks after intake
Waist circumference diameter, hip circumference diameter, body weight, BMI, total cholesterol, HDL-cholesterol, LDL-cholesterol, and fasting blood glucose at 4,8 and 12 weeks after intake
HbA1c and adiponectin at 12 weeks after intake
<Safety>
Adverse event incidence, clinical examination items excluding efficacy evaluation items, and physiological examination items excluding efficacy evaluation items

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of test food for 12 weeks
Interventions/Control_2 Intake of placebo food 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 Male and Female
Key inclusion criteria 1. Males and females equal to or more than 20 years and less than 65 years of age
2. Subjects equal to or more than 24 and less than 30 kg/m^2 of BMI
3. Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria 1. Subjects who have a history of severe illness and current medical history in the heart, liver, kidney, digestive organs
2. Subjects who fall under the
diagnostic criteria of metabolic syndrome
3. Subjects who received medication treatment or surgery due to serious illness or injury within 2 months from the start of this study
4. Subjects who use drugs of
glycometabolism, lipidmetabolism, or reducing high blood pressure
5. Subjects who regularly use drugs, health foods, supplements which are suggested causal relationship from the study except who agree to quit taking them
6. Pregnant and lactating female, or who wish to get pregnant during the study period
7. Heavy dinkers
8. Subjects who feel bad mood by blood collection in past
9. Subjects who donated 200 mL or more of blood within 1 month from the start of the test or subjects who plan to do so during the test period
10. Subjects who have been
constipated for more than 5 days
11. Shift worker
12. Subjects who have allergy related to the test foods
13. Subjects already participating in other clinical trials, subjects
planning to participate during this examination period
14. Subjects who can not agree with the purpose of this test conducted in advance
15. Subjects who are ineligible due to physician's judgment
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikuo Fukuhara
Organization Fukuhara Clinic
Division name Hospital director
Zip code
Address 3-1-15 Shimamatsuhigashi-machi Eniwa, Hokkaido, Japan
TEL 0123-36-8029
Email i-feniwa@gray.plala.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomita Shimpei
Organization New drug research center, Inc.
Division name Clinical Research Dept.
Zip code
Address 452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL 0123-34-0412
Homepage URL
Email s-tomita@ndrcenter.co.jp

Sponsor
Institute Maruzen Pharmaceuticals Co., Ltd.
Institute
Department

Funding Source
Organization Maruzen Pharmaceuticals Co., Ltd.
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

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 07 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
2017 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 24 Day
Last modified on
2017 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030198

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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