UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041238
Receipt number 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 2021/01/27 09:33:15

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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 or person

Institute

KSO Corporation

Institute

Department

Personal name



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

Value
https://center6.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