UMIN-CTR Clinical Trial

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
Email	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
Email	s.yamamichi@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042198