UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037107 |
|---|---|
| Receipt number | R000042283 |
| Scientific Title | Study on evaluation of reduction effect of test supplement on body weight -a randomized, double blind, placebo controlled, parallel group comparison study- |
| Date of disclosure of the study information | 2019/06/20 |
| Last modified on | 2020/06/12 09:09:16 |
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Basic information
Public title
Study on evaluation of reduction effect of test supplement on body weight -a randomized, double blind, placebo controlled, parallel group comparison study-
Acronym
Body weight reduction effect of test supplement
Scientific Title
Study on evaluation of reduction effect of test supplement on body weight -a randomized, double blind, placebo controlled, parallel group comparison study-
Scientific Title:Acronym
Body weight reduction effect of test supplement
Region
| Japan |
Condition
Condition
Healthy adult
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 weight
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight
Key secondary outcomes
Abdominal visceral fat area, abdominal total fat area, abdominal subcutaneous fat area, BMI, body fat percentage, 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
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
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.
3. Subjects who can understand the aim of this study and have the competency for giving consent.
Key exclusion criteria
1 Subjects who currently are dieting
2 Subjects who have some metal which the abdomen cannot remove
3 Subjects who have bolt in lumbar spine
4 Subjects who have stoma
5 Subjects who plan the examination with barium within one week before each examination day after screening test step 2
6 Subjects who are currently under medical treatment
7 Subjects who are currently under exercise and dietary treatment
8 Subject who have an allergy against trial supplement
9 Subjects who have current disease or history of drug and/or alcoholism
10 Subjects who have current treatment or history of mental disorder and/or sleep disorder
11 Subjects who are night shift or shift workers
12 Subjects with extremely irregular lifestyles such as food and sleep
13 Subjects who have an extreme unbalanced diet
14 Subjects who have serious disease or history
15 Subjects who use health foods, supplements and medicines that affect weight and lipid metabolism
16 Subjects who participated in other clinical trials within one month from the date of obtaining consent, or who plan to participate in other clinical trials during the trial period
17 Subjects who carried out blood collection, component blood donation more than 400 mL within 200 mL or 3 months within one month going back from the date of consent acquisition
18 Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period.
19 Subjects who have a habit of taking a food containing a large amount of lactic acid bacteria for 3 days or more a week
20 Subjects who always use a laxative for defecation
21 Subjects who used probiotics, antibiotics
22 Subjects who have difficulty in keeping records on various questionnaires
23 Subjects who have difficulty in keeping records on various questionnaires
24 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
2440806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
0458203755
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi. 10th Fl., 5-31-19 Shiba,Minato-ku, Tokyo
TEL
03-3431-1260
Homepage URL
ochitani@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committees of Nihonbashi Egawa Clinic
Address
Kotobuki Building, 1-1-3, Yaesu, Chuo-ku, Tokyo
Tel
03-5204-0311
jim@medipharma.co.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
医療法人共創会 AMC西梅田クリニック
医療法人あけぼの会 あけぼのＧＭクリニック
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 20 | 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
100
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 | 14 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 28 | 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 | 19 | 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=R000042283
