UMIN-CTR Clinical Trial

Basic information
Public title	Diet effect confirmation test ~Diet test by ingesting The fermentation hydrogen 328 selections Mogitate Nama-smoothie and The Fermentation hydrogen 328 selections Nama-supplement Nen.~ -Open study-
Acronym	Diet effect confirmation test
Scientific Title	Diet effect confirmation test ~Diet test by ingesting The fermentation hydrogen 328 selections Mogitate Nama-smoothie and The Fermentation hydrogen 328 selections Nama-supplement Nen.~ -Open study-
Scientific Title:Acronym	Diet effect confirmation test
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effect of decreasing in body weight and visceral fat area when one meal is replaced with a substitute meal for 12 weeks, and that vitamins in the body are increased by ingesting supplements and healthy diet can be achieved.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Abdominal Visceral Fat Area
Key secondary outcomes	<Efficacy> 1) Weight (BMI)(Visit date) 2) Weight (From ingestion start date to the day before 12W) 3) Body temperature (From ingestion start date to the day before 12W) 4) SFA, TFA 5) Waist circumference / Hip circumference 6) Body fat percentage, body fat mass, muscle mass 7) Biochemical examination 8) Skin, physical condition and cold questionnaire(VAS) <Safety> 1) Interview 2) Blood pressure/pulse rate 3) Hematology test 4) Biochemical examination 5) Urinalysis 6) Subjective symptoms 7) Adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Food1: Once a day, dissolve 6 g of the test meal in about 200 ml of water and take instead of dinner. Food2: Take 3 tablets twice daily in the morning and at night with 100 ml of water.
Interventions/Control_2
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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Female
Key inclusion criteria	(1) Females from 20 to 64 years-old with a BMI of 25 or above on the date of consent acquisition. (2) Subjects who with apparently excessive caloric intake. (3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	(1) Subjects who have been diagnosed with severe anemia by the results of screening test. (2) Subjects who regularly take medicines. (3) Subjects who cannot stop taking drugs, supplements, and health foods that may affect obesity, hyperlipidemia, lipid metabolism, etc. during the test period. (4) Subjects who suffers from urgent medical treatment or has serious complications. (5) Subjects with a digestive organ disease or surgical history that has an influence on digestive absorption. (6) Subjects who taking supplements and health foods. (7) Subjects who have allergic to the test food ingredients. (8) Those who are allergic to orange, cashew nut, kiwifruit, sesame, soybean, banana, peach, walnut, apple, yam, almond, wheat, gelatin. (9) Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. (10) Subjects who has metal in DUAL SCAN measurement site due to surgery etc. (11) Subjects who have implantable medical devices such as cardiac pacemakers or implantable defibrillators. (12) Subjects who cannot stop drinking more than 20g per day equivalent to pure alcohol. (13) Subjects who has a medical history or current medical history of drug dependence or alcohol dependence. (14) Subjects who are shift workers or midnight workers. (15) Those who have been diagnosed with familial hyperlipidemia. (16) Subjects who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics. (17) Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yoshitaka Middle name Last name Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Zip code	103-0001
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Komori
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	eigyou27@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	JFRONTIER Co., Ltd
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	Ethical Committee of Kobuna Orthopedics Clinic
Address	5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel	027-212-5608
Email	sagawa@mc-connect.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

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 01 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
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	2020 Year 03 Month 26 Day
Date of IRB	2020 Year 04 Month 02 Day
Anticipated trial start date	2020 Year 08 Month 02 Day
Last follow-up date	2020 Year 11 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 29 Day
Last modified on	2021 Year 01 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047080