UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048306 |
|---|---|
| Receipt number | R000055027 |
| Scientific Title | A study of the effect of continuous intake of test food on ketone body and lipid concentration. - an open-label trial - |
| Date of disclosure of the study information | 2022/07/06 |
| Last modified on | 2024/05/20 15:47:17 |
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Basic information
Public title
A study of the effect of continuous intake of test food on ketone body and lipid concentration. - an open-label trial -
Acronym
A study of the effect of continuous intake of test food on ketone body and lipid concentration. - an open-label trial -
Scientific Title
A study of the effect of continuous intake of test food on ketone body and lipid concentration. - an open-label trial -
Scientific Title:Acronym
A study of the effect of continuous intake of test food on ketone body and lipid concentration. - an open-label trial -
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This trial aims to investigate the effect of 2 weeks intake of the test food on blood and breath levels of ketone body and blood level of lipids.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration of ketone bodies
Key secondary outcomes
Blood levels of triglycerides, total cholesterol, and LDL-cholesterol
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
Take test food once a day at breakfast for 2 weeks.
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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1. Japanese females with aged 30 and 50 years at the time of informed consent
2. Those who regularly have three meals a day
3. Those who have no history, within 1 month, of intake of MCT oil or oils contains MCT at 60% or more
4. Those who fit to any of bellows,
- gained 10 kg or more of weight after 20th birthday and with current BMI between 25.0 and 30.0 kg/m^2.
- no significant change in the weight after 20th birthday and with current BMI between 18.0 and 25.0 kg/m^2.
5. Those who received the sufficient explanation for the objective and summary of the trial, voluntarily decided to participate in the trial after understanding the purpose and made the written agreement
Key exclusion criteria
1. Those who have been currently visiting a hospital or treated with any drug or herbal remedy for any disease
2. Those who are on diet/exercise therapy under the guidance of a doctor
3. Those who currently have or have history of severe diseases
4. Those who have serious anemia
5. Those who daily take medicine, quasi-medicine, food for specified health uses or nutritional supplements / foods on the market that have health claims related to fatigue, stress relief, cold intolerance, blood flow, blood pressure or calefacient (excluding individuals who can refrain from ingestion after receiving informed consent until the end of the study)
6. Those who currently have or have a history of drug and/or food allergies
7. Those who have donated 200 mL of the blood, including ingredient blood, within 1 months before start of the study
8. Those who have donated 400 mL of the blood within 4 months before start of the study
9. Those who joined other clinical trials within 1 month before receiving informed consent in this study, or those who are currently joining other clinical trials
10. Those who are currently pregnant, breastfeeding or planning to get pregnant during the study period.
11. Those who routinely take alcohol more than 60 g/day
12. Those who have smoked within a year
13. Those who cannot agree to abandon daily exercise from 3 days before start of food intake until end of the study
14. Those who have habits of irregular meals, or those who have irregular life rhythm such as night work or spilt shift
15. Those who are judged by the physician to be unsuitable for this study.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Shimizu |
Organization
Medical corporation Seishukai
Hasegawa Hospital
Division name
Hospital director
Zip code
116-0014
Address
5-45-7 Higashinippori, Arakawa-ku, Tokyo, Japan
TEL
03-3807-8866
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 Japan
TEL
03-6704-5968
Homepage URL
https://imeqrd.co.jp/
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Integrate co.,ltd.
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,Shinjuku-ku,Tokyo
Tel
03-6704-5968
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
| 2022 | Year | 07 | Month | 06 | 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
| 2022 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 06 | Day |
Last modified on
| 2024 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055027
