UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on body fat, intestinal bacteria, and other vital data in healthy Japanese subjects

Acronym

Effects of consumption of the test food on body fat, intestinal bacteria, and other vital data in healthy Japanese subjects

Scientific Title

Effects of consumption of the test food on body fat, intestinal bacteria, and other vital data in healthy Japanese subjects: an open-label trial

Scientific Title:Acronym

Effects of consumption of the test food on body fat, intestinal bacteria, and other vital data in healthy Japanese subjects

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of consumption of the test food on the body fat in healthy Japanese subjects

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. Body mass index (BMI) at eight weeks after consumption (8w)

Key secondary outcomes

1. Body weight, body fat percentage, fat mass, lean body mass, muscle mass, diversity of intestinal bacteria, list of all bacteria species, share ratio of major bacteria, and f/b values at 8w

2. Body weight, BMI, body fat percentage, visceral fat percentage, basal metabolic rate, and body age between one week after consumption and 8w

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: Eight weeks
Test food: 100calatt (frozen ready-made side dish)
Administration: For five days per week, replace any one of your regular daily meals with the test food.

* For two days when meals are not replaced, you should continue to have the daily meals.
* If you have had the daily amount of meals before consumption of the test food, do not take it.
*Make sure not to exceed the normal daily amount of meals.
*Daily dose should be taken within the day and not carried over to the next day.

Interventions/Control_2

Duration: Eight weeks
Test food: 100calatt (frozen ready-made side dish)
Administration: For five days per week, replace any two of your regular daily meals with the test food.

* For two days when meals are not replaced, you should continue to have the daily meals.
* If you have had the daily amount of meals before consumption of the test food, do not take it
*Make sure not to exceed the normal daily amount of meals.
*Daily dose should be taken within the day and not carried over to the next day.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

30

years-old

<=

Age-upper limit

60

years-old

>

Gender

Female

Key inclusion criteria

1. Japanese

2. Women

3. Subjects aged 30 or more and less than 60

4. Healthy subjects

5. Subjects who can store and consume the test food as the prescribed method

6. Subjects with a height of 150 cm or more and less than 175 cm

7. Subjects with a body weight of 50 kg or more and less than 90 kg

8. Subjects with a BMI of 23 kg/m² or more and less than 30 kg/m²

Key exclusion criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily

5. Subjects who are currently taking medications (including herbal medicines) and supplements

6. Subjects who are a smoker

7. Subjects who drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)}

8. Subjects whose sleeping time or habit is irregular due to work such as a late-night shift

9. Subjects whose meal time is irregular

10. Subjects who are allergic to medicines and/or the test food related products (particularly, wheat, beef, pork, eggs, chicken, soy, milk ingredients, sesame, mackerel, shrimp, almonds, bananas, cashew nuts, walnuts, salmon, peach, or Japanese yam)

11. Subjects who are pregnant, lactating, or planning to become pregnant during this trial

12. Subjects who suffer from COVID-19

13. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

14. Subjects who are judged as ineligible to participate in this study by the physician

Target sample size

10

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-5793-3623

Email

t-takara@takara-clinic.com

Name of contact person

1st name	Naoko
Middle name
Last name	Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

AIVICK Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

IRB@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Date of disclosure of the study information

2022

Year

11

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

12

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

Recruitment status

Completed

Date of protocol fixation

2022

Year

11

Month

16

Day

Date of IRB

2022

Year

11

Month

16

Day

Anticipated trial start date

2022

Year

11

Month

30

Day

Last follow-up date

2023

Year

12

Month

03

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

11

Month

30

Day

Last modified on

2024

Year

04

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056539