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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042953
Receipt No. R000049021
Scientific Title Study of the effect of continuous intake of test food on blood ketone concentration.
Date of disclosure of the study information 2021/01/13
Last modified on 2021/01/08

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Basic information
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
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes Blood ketone concentration
Key secondary outcomes Weight, body fat, BMI

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute IMEQRD inc.
Institute
Department

Funding Source
Organization non-disclosure
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
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
2021 Year 01 Month 13 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
2021 Year 01 Month 07 Day
Date of IRB
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
Other related information

Management information
Registered date
2021 Year 01 Month 08 Day
Last modified on
2021 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049021

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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