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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041238
Receipt No. R000047080
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-
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/28

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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 Preinitiation
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
2020 Year 07 Month 28 Day


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

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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