UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042953 |
|---|---|
| Receipt number | 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 | 2024/05/17 12:41:15 |
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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
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD inc.
Institute
Department
Personal name
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
jimukyoku@imeqrd.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
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
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 08 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049021
