Unique ID issued by UMIN | UMIN000054045 |
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Receipt number | R000061678 |
Scientific Title | Verification of the effect of different intake times on the absorption of food components: open-label, crossover trial |
Date of disclosure of the study information | 2024/04/05 |
Last modified on | 2024/04/02 09:15:17 |
Verification of the effect of different intake times on the absorption of food components
Verification of the effect of different intake times on the absorption of food components
Verification of the effect of different intake times on the absorption of food components: open-label, crossover trial
Verification of the effect of different intake times on the absorption of food components
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To verify the effect of intake time on the absorption of food components.
Bio-availability
Area under the food component concentration curve (AUC) in the serum triglyceride-rich lipoprotein fraction and the change of AUC.
Concentration of the food component in the serum triglyceride-rich lipoprotein fraction after ingestion of the test food and the change from before ingestion.
Interventional
Cross-over
Non-randomized
Open -no one is blinded
Active
NO
NO
NO
No need to know
3
Prevention
Food |
A single ingestion of the test food (200 mL) at breakfast time.
A single ingestion of the test food (200 mL) at lunch time
A single ingestion of the test food (200 mL) at dinner time.
20 | years-old | <= |
40 | years-old | > |
Male and Female
1. Healthy people aged 20 to 29 years.
2. Who agree to participate in the trial and have completed a medical interview and pre-test.
1. Whose body mass index (BMI) is less than 18.5 or above 25.
2. Who has a history of major surgery on the digestive system (except appendicitis).
3. Who visit the hospital for treatment of illnesses or receiving medication.
4. Lactating, pregnant or planning to be pregnant during this trial.
5. who have allergic reaction to test foods.
6. Smokers (who have smoked within the last 6 months).
7. Who have irregular lifestyles, such as shift workers and late-night workers.
8. Who consume vegetable or vegetable-fruit drinks on a daily basis (approx. three times a week or more).
9. Who have given blood in the last six months.
10. Who have participated in other human trials within one month.
11. Who are judged unsuitable for this trial by the principal investigator.
36
1st name | Shingo |
Middle name | |
Last name | Takahashi |
KAGOME CO., LTD.
Diet & Well-being Research Institute
329-2762
17 Nishitomiyama, Nasushiobara-shi, Tochigi
0287-36-2935
g167_0@kagome.co.jp
1st name | Hayato |
Middle name | |
Last name | Ouchi |
Seisyukai Clinic, Seishukai Medical corporation
Clinical trial division
111-0036
3-18-5, Matsugaya, Taito-ku, Tokyo
03-5827-0930
h-ouchi@seishukai.or.jp
KAGOME CO., LTD.
None
Self funding
CPCC Company Limited
Seishukai Clinic Institutional Review Board
3-18-5 Matsugaya, Taito-ku, Tokyo
03-5827-0930
t-takahama@seishukai.or.jp
NO
2024 | Year | 04 | Month | 05 | Day |
Unpublished
Preinitiation
2024 | Year | 03 | Month | 21 | Day |
2024 | Year | 03 | Month | 29 | Day |
2024 | Year | 04 | Month | 08 | Day |
2024 | Year | 08 | Month | 31 | Day |
2024 | Year | 04 | Month | 03 | Day |
2024 | Year | 04 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061678
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