UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034316
Receipt No. R000039120
Scientific Title Effects of consumption of the test food on body fat: a randomized, double-blind, placebo-controlled, parallel-group trial
Date of disclosure of the study information 2018/09/28
Last modified on 2019/03/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of consumption of the test food on body fat: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym Effects of consumption of the test food on body fat
Scientific Title Effects of consumption of the test food on body fat: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym Effects of consumption of the test food on body fat
Region
Japan

Condition
Condition Japanese subjects between 23 kg/m2 or more and less than 30 kg/m2 in body mass index (BMI)
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effect on body fat with the consumption of the test food for 12 weeks in Japanese adult subjects between 23 kg/m2 or more and less than 30 kg/m2 in BMI
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 in a cross section of the umbilical region

* Assess the fat area by X-ray CT
* Calculate the amount of change between screening (before consumption) and 12 weeks after consumption
Key secondary outcomes 1. Total fat area
2. Subcutaneous fat area
3. Visceral fat area
4. Body weight
5. Body mass index
6. Body fat percentage
7. Lean body mass
8. Muscle mass
9. Abdominal circumference
10. Basal metabolic rate
11. Abdominal obesity ratio

*1-3 Assess these by X-ray CT
*1-11 Conduct these at screening (before consumption) and 4, 8, and 12 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 YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 12 weeks
Test material: Active capsule
Dose and Administration: Take one capsule per day after breakfast with water or lukewarm water

* If you forget to take the capsule, take it as soon as you remember within the day.
Interventions/Control_2 Duration: 12 weeks
Test material: Placebo capsule
Dose and Administration: Take one capsule per day after breakfast with water or lukewarm water

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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Japanese adult subjects

2. Subjects who are between 23 kg/m2 or more and less than 30 kg/m2 in BMI

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

4. Within the subjects who met the 1st to 3rd inclusion criteria, subjects whose visceral fat area assessed by X-ray CT are relatively large
Key exclusion criteria 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

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

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

5. Subjects who excessive exercise

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

7. Subjects who could have any allergens in raw materials of the test food (soybean and gelatin), or possible to have serious allergic reactions to other foods and/or medicines

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

9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period

10. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 80

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 DHC Corporation
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 09 Month 28 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 88
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 No longer recruiting
Date of protocol fixation
2018 Year 09 Month 25 Day
Date of IRB
2018 Year 09 Month 25 Day
Anticipated trial start date
2018 Year 09 Month 29 Day
Last follow-up date
2019 Year 04 Month 27 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 09 Month 28 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=R000039120

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.