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 |
A study of the effect of continuous intake of test food on ketone body and lipid concentration. - an open-label trial -
A study of the effect of continuous intake of test food on ketone body and lipid concentration. - an open-label trial -
A study of the effect of continuous intake of test food on ketone body and lipid concentration. - an open-label trial -
A study of the effect of continuous intake of test food on ketone body and lipid concentration. - an open-label trial -
Japan |
Healthy adults
Adult |
Others
NO
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.
Safety,Efficacy
Concentration of ketone bodies
Blood levels of triglycerides, total cholesterol, and LDL-cholesterol
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Take test food once a day at breakfast for 2 weeks.
30 | years-old | <= |
50 | years-old | > |
Female
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
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.
12
1st name | Hiroyuki |
Middle name | |
Last name | Shimizu |
Medical corporation Seishukai
Hasegawa Hospital
Hospital director
116-0014
5-45-7 Higashinippori, Arakawa-ku, Tokyo, Japan
03-3807-8866
clinical-trial@imeqrd.co.jp
1st name | Yoshitada |
Middle name | |
Last name | Hira |
IMEQRD Co., Ltd
Planning and Sales Department
104-0061
6-2-1 Ginza Chuo-ku Tokyo Japan
03-6704-5968
https://imeqrd.co.jp/
clinical-trial@imeqrd.co.jp
IMEQRD Co., Ltd
Integrate co.,ltd.
Profit organization
Suda Clinic institutional review board
2-8-14,Takadanobaba,Shinjuku-ku,Tokyo
03-6704-5968
jimukyoku@imeqrd.co.jp
NO
2022 | Year | 07 | Month | 06 | Day |
Unpublished
Completed
2022 | Year | 06 | Month | 25 | Day |
2022 | Year | 06 | Month | 28 | Day |
2022 | Year | 07 | Month | 07 | Day |
2022 | Year | 08 | Month | 04 | Day |
2022 | Year | 07 | Month | 06 | Day |
2024 | Year | 05 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055027