UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037062 |
|---|---|
| Receipt number | R000042198 |
| Scientific Title | Study on evaluation of reduction effect of test supplement on body fat -a randomized, double blind, placebo controlled, parallel group comparison study- |
| Date of disclosure of the study information | 2019/06/14 |
| Last modified on | 2020/06/12 09:04:11 |
* 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
Study on evaluation of reduction effect of test supplement on body fat -a randomized, double blind, placebo controlled, parallel group comparison study-
Acronym
Body fat reduction effect of test supplement
Scientific Title
Study on evaluation of reduction effect of test supplement on body fat -a randomized, double blind, placebo controlled, parallel group comparison study-
Scientific Title:Acronym
Body fat reduction effect of test supplement
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to assess the effect of test supplement on body fat.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abdominal visceral fat area
Key secondary outcomes
Abdominal total fat area, abdominal subcutaneous fat area, body weight, BMI, waist circumference, hip circumference, ratio of waist and hip circumferences, subgroup analysis (BMI, abdominal visceral fat area, sex, defecation frequency)
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test supplement for 12 consecutive weeks
Interventions/Control_2
Intake of placebo for 12 consecutive 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
| 45 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese male and female whose age is between 45 and 70 years old
2. Subjects whose BMI is between 23 and 30
Key exclusion criteria
1. Subjects who are currently under medical treatment, diet therapy or exercise therapy.
2. Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease, abnormal secretion disease of adrenocortical hormone)
3. Subjects with allergies to the test food in this study
4. Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period.
5. Subjects who routinely use some medicine, health foods affecting body fat or lipid metabolism.
6. Subjects who currently are dieting.
7. Subjects who have participated in other clinical study within the past month prior.
8. Subjects who use some medicine, food containing lactic acid bacteria or polymethoxyflavone 3 days a week or more from half a year before the informed consent.
9. Subjects who are judges as unsuitable for the study based on the results of lifestyle questionnaire
10. Subjects who are judged as unsuitable for the study based on the results of clinical laboratory test or cardiopulmonary function.
11. Subjects who have diseases requiring continuous medication, or serious medical history who needed medication therapy
12. Subjects who always use laxative when defecation.
13. Subjects who have taken antibiotics within the past month
14. Subjects who are judged as unsuitable for the study based on the results of clinical laboratory test or physical examination.
15. Subjects who are planning to travel abroad during the study period, or who are planning of long term domestic trip for more than one week in study period.
16. Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yui |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3755
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Yamamichi |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
150-0021
Address
1-20-2, Ebisu-nishi, Shibuya-ku, Tokyo, Japan
TEL
03-5459-5329
Homepage URL
s.yamamichi@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
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
Aisei Hospital Ueno Clinic Research Ethics Committee
Address
2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel
03-6455-0880
t.saito@ttc-smo.jp
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
| 2019 | Year | 06 | Month | 14 | 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
104
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
| 2019 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 13 | Day |
Last modified on
| 2020 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042198
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
