UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035208 |
|---|---|
| Receipt number | 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 09:52:40 |
* 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
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
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040085
