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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037107
Receipt No. 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

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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
Email 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
Email ochitani@huma-rd.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042283

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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