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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032691
Receipt No. R000037280
Scientific Title A verification study of the anti-obesity effect of the test food: a randomized, double-blind, placebo-controlled, parallel-group trial
Date of disclosure of the study information 2018/05/23
Last modified on 2019/03/31

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Basic information
Public title A verification study of the anti-obesity effect of the test food: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym A verification study of the anti-obesity effect of the test food
Scientific Title A verification study of the anti-obesity effect of the test food: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym A verification study of the anti-obesity effect of the test food
Region
Japan

Condition
Condition Japanese subjects between 23 kg/m2 or more and less than 30 kg/m2 in BMI
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the visceral fat reducing effect with the consumption of the test food for 8 weeks
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The visceral fat area of umbilicus cross section

* Assessed the fat area by X-ray CT
* Calculate the amount of change between before consumption and 8 weeks after consumption
Key secondary outcomes 1. Total fat area
2. Subcutaneous fat area
3. Visceral fat area
4. Serum adiponectin
5. Serum total cholesterol
6. Serum HDL cholesterol
7. Serum LDL cholesterol
8. Serum neutral fat (TG: triglyceride)
9. Serum glucose
10. Serum levels of glyceraldehyde-derived advanced glycation end-products
11. Plasma amyloid beta
12. Serum epidermal growth factor
13. Body weight
14. Body mass index
15. Body fat percentage
16. Abdominal circumference
17. Subjective symptoms

*1-3 Assessed these by X-ray CT
*17 Assessed these symptoms by the Likert scale
*1-3 Measure the fat area of umbilicus cross section and calculate the amount of change between before consumption and 8 weeks after consumption. Visceral fat area value will be only measured.
*1-17 Assess these tests at screening and examination before consumption and at 4 and 8 weeks after consumption

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 8 weeks
Test material: Test food A
Dose: Take 3 tablets per day
Administration: Take the tablet with a glass of water before each meal

* If you forget to take the tablet, take it as soon as you remember within the day.
Interventions/Control_2 Duration: 8 weeks
Test material: Test food B
Dose: Take 3 tablets per day
Administration: Take the tablet with a glass of water before each meal

* If you forget to take the tablet, take it as soon as you remember within the day.
Interventions/Control_3 Duration: 8 weeks
Test material: Placebo
Dose: Take 3 tablets per day
Administration: Take the tablet with a glass of water before each meal

* If you forget to take the tablet, take it as soon as you remember within the day.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Japanese adult subjects between 23 kg/m2 or more and less than 30 kg/m2 in BMI

2. Subjects who are judged as eligible to participate in the study by the physician

3. Subjects who are between 23 kg/m2 or more and less than 25 kg/m2 in BMI or between 25 kg/m2 or more and less than 30 kg/m2 in BMI with less than 100 cm2 in the visceral fat area at screening

4. Within the subjects who met the 2nd and 3rd inclusion criteria, subjects who are relatively high levels of blood glucose at screening
Key exclusion criteria 1. A medical history of malignant tumor, heart failure or myocardial infarction

2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily

4. Subjects who have exercise habits more than 3 times per week

5. Subjects who are currently taking medications (including herbal medicines) and supplements

6. Subjects who are allergic to medicines and/or the test food related products

7. Subjects who are pregnant, lactation, or planning to become pregnant

8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial

9. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Kazuo
Middle name
Last name YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name Naoko
Middle name
Last name SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization Toyo Sugar Refining Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel 03-5793-3623
Email info@takara-clinic.com

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 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 23 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 66
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 08 Day
Date of IRB
2018 Year 05 Month 08 Day
Anticipated trial start date
2018 Year 05 Month 24 Day
Last follow-up date
2018 Year 12 Month 22 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 23 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037280

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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