UMIN-CTR Clinical Trial

Public title

Study of the effect of continuous intake of test food on blood ketone concentration.

Acronym

Study of the effect of continuous intake of test food on blood ketone concentration.

Scientific Title

Study of the effect of continuous intake of test food on blood ketone concentration.

Scientific Title:Acronym

Study of the effect of continuous intake of test food on blood ketone concentration.

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effects of test food ingestion on blood ketone concentration and mitochondrial activity in healthy adult men and women aged between 20 and 40 years.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Blood ketone concentration

Key secondary outcomes

Weight, body fat, BMI

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Take the test food (high content) once a day

Interventions/Control_2

Take the test food (low content) once a day

Interventions/Control_3

Take placebo food once a day

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

40

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Aged between 20 and 40 years at the time of informed consent
2. Japanese male or female
3. BMI of over 20.0 to under 25.0
4. Those who can input electronic diary with smartphone/PC
5. Those who can understand the contents of the study and provide written consent before study based on their free will

Key exclusion criteria

Subjects who
1. are currently receiving any types of medicines and/or Chinese medical treatment (except for the drugs taken as needed)
2. are on diet and exercise therapy under the supervision of a doctor
3. have serious liver, kidney, heart, respiratory, endocrine or metabolic diseases.
4. are or were going on diet such as carbohydrate restriction within one month
5. are currently using quasi-drugs, foods for specified health use, health foods and supplements (those who can stop after obtaining consent are acceptable)
6. have a current or previous history of drug and/or food allergies (those who may have allergic symptoms to the test food)
7. Donated component blood or 200ml of whole blood within one month before the study
8. Men who donate 400ml of whole blood from 3 months before the study or women who donates 400ml of whole blood within 4 months before the study
9. have participated in or are currently participating in other clinical trials within one month before obtaining consent, or those who are planning to participate during the study period
10. are currently pregnant or breastfeeding or those who want to become pregnant during the test period
11. consume alcohol excessively (alcohol equivalent 60g or more / day)
12. have smoking habits
13. have an irregular diet, or irregular life rhythms (work in shifts, work late at night etc.)
14. are judged by the investigator to be unsuitable for participating in this study

Target sample size

24

Name of lead principal investigator

1st name	Kiyoshi
Middle name
Last name	Nakamura

Organization

Higashikoganei Sakura Clinic

Division name

chairman

Zip code

184-0011

Address

4-37-26 Higashi-cho, Koganei-shi, Tokyo

TEL

042-382-3888

Email

higashikoganeisakura-clinic@imeq.co.jp

Name of contact person

1st name	Keiichi
Middle name
Last name	Horiguchi

Organization

IMEQRD inc.

Division name

Sales department

Zip code

104-0061

Address

6-2-1 Ginza Chuo-ku Tokyo

TEL

03-6704-5968

Homepage URL

Email

k-horiguchi@imeqrd.co.jp

Institute

IMEQRD inc.

Institute

Department

Personal name

Organization

non-disclosure

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Suda Clinic institutional review board

Address

2-8-14,Takadanobaba,Shinjyuku,Tokyo

Tel

03-3207-8161

Email

suda-clinic_irb@imeq.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

01

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2021

Year

01

Month

07

Day

Date of IRB

2021

Year

01

Month

08

Day

Anticipated trial start date

2021

Year

01

Month

14

Day

Last follow-up date

2021

Year

02

Month

27

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

01

Month

08

Day

Last modified on

2021

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=R000049021