UMIN-CTR Clinical Trial

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