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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035208
Receipt No. R000040085
Scientific Title A verification study of the dose dependence with the test food on healthy and overweight humans: a randomized, double-blind, placebo-controlled, parallel-group trial
Date of disclosure of the study information 2018/12/10
Last modified on 2019/08/21

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Basic information
Public title A verification study of the dose dependence with the test food on healthy and overweight humans: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym A verification study of the dose dependence with the test food on healthy and overweight humans
Scientific Title A verification study of the dose dependence with the test food on healthy and overweight humans: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym A verification study of the dose dependence with the test food on healthy and overweight humans
Region
Japan

Condition
Condition Healthy and overweight Japanese adult subjects between 23 kg/m2 or more and less than 30 kg/m2 in body mass index (BMI)
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the dose dependence with the test food on healthy and overweight subjects
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
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. Body water
9. Muscle mass
10. Abdominal circumference
11. Basal metabolic rate
12. Waist circumference
13. Hip circumference
14. Abdominal obesity ratio
15. Subjective symptoms (the Likert scale)

*1-3 Assess these by X-ray CT of the umbilical region
*1, 2 Compare the measured values at screening (before consumption) and at 12 weeks after consumption and calculate the amount of change
*3 Compare the measured values between screening (before consumption) and 12 weeks after consumption
*4-15 Compare the measured values at screening (before consumption) and at 4, 8, and 12 weeks after consumption and calculate the amount of change

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 12 weeks
Test material: Tablet containing sugars (high dose)
Dose and Administration: Take 1 tablet, three times per day before each meal with water

* If you forget to take the tablet, take it as soon as you remember within the day.
Interventions/Control_2 Duration: 12 weeks
Test material: Tablet containing sugars (intermediate dose)
Dose and Administration: Take 1 tablet, three times per day before each meal with water

* If you forget to take the tablet, take it as soon as you remember within the day.
Interventions/Control_3 Duration: 12 weeks
Test material: Tablet containing sugars (low dose)
Dose and Administration: Take 1 tablet, three times per day before each meal with water

* If you forget to take the tablet, take it as soon as you remember within the day.
Interventions/Control_4 Duration: 12 weeks
Test material: Tablet containing polyphenols
Dose and Administration: Take 1 tablet, three times per day before each meal with water

* If you forget to take the tablet, take it as soon as you remember within the day.
Interventions/Control_5 Duration: 12 weeks
Test material: Sugar free tablet (Placebo)
Dose and Administration: Take 1 tablet, three times per day before each meal with water

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

2. Japanese adult subjects

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

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

5. Meeting the 1st to 4th criteria requirements, subjects whose visceral fat area, assessed by X-ray CT, are relatively large with less than 100 cm2, or more than 100 cm2
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 excessive exercise

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

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

7. Subjects who are an allergic reaction to medications and/or products that contain the study ingredients

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 ineligibility to participate in the study based on the evaluation of the principal physician
Target sample size 45

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 Yaizu Suisankagaku Industry 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 12 Month 10 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 50
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 12 Month 04 Day
Date of IRB
2018 Year 12 Month 04 Day
Anticipated trial start date
2018 Year 12 Month 10 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 12 Month 10 Day
Last modified on
2019 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040085

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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