Unique ID issued by UMIN | UMIN000023820 |
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Receipt number | R000027438 |
Scientific Title | Effect of supplement on respiratory metabolism. -a randomized, double-blind, placebo-controlled, cross-over study- |
Date of disclosure of the study information | 2016/08/30 |
Last modified on | 2017/06/06 17:50:03 |
Effect of supplement on respiratory metabolism. -a randomized, double-blind, placebo-controlled, cross-over study-
Effect of supplement on respiratory metabolism.
Effect of supplement on respiratory metabolism. -a randomized, double-blind, placebo-controlled, cross-over study-
Effect of supplement on respiratory metabolism.
Japan |
Healthy volunteer
Not applicable | Adult |
Others
NO
This study aims to evaluate the effect of ingestion of supplement on respiratory metabolism.
Efficacy
Fat oxidation
Volume of oxygen consumption (VO2)
Volume of carbon dioxide output (VCO2)
Respiratory quotient
Energy expenditure
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Measurement of respiratory metabolism in rest and exercise after single oral intake of supplement -> washout period (1 week) -> measurement of respiratory metabolism in rest and exercise after single oral intake of placebo
Measurement of respiratory metabolism in rest and exercise after single oral intake of placebo -> washout period (1 week) -> measurement of respiratory metabolism in rest and exercise after single oral intake of supplement
25 | years-old | <= |
45 | years-old | >= |
Male
1)Japanese males aged 25 to 45 years.
2)Healthy subjects who do not have some kind of disease treatment.
3)Subjects who have not performed regular exercise of one or more times per week within the past two years.
4)Subjects who eat three meals (breakfast, lunch, dinner) a day regularly.
5)BMI >=20 kg/m2 and <25kg/m2
6)Percent body fat >=10% and <=20%
7)Subjects who can eat only the provided meals from three days before until one day before of the measurement.
8)Subjects who can stay in the specific hotel a day before the measurement.
9)Subjects who received a sufficient explanation about the purpose and content of this study and have a consent ability and volunteered to participate in the understanding and can agree to this study participation in writing
10)Subjects who were deemed appropriate to participate in the study by the investigator.
1)Subjects who are undergoing medication suffer from some sort of disease.
2)Subjects who frequently become anemic symptoms.
3)Subjects who are might cause allergic symptoms to test foods or the provided meals, furthermore might cause serious allergic symptoms to the other foods or medicines.
4)Subjects who have a intake habit of continued medicines, quasi-drugs, food with health claims (food for specified health use), health foods and supplements such currently or within the past three months, furthermore going to their intake during the study period.
5)Subjects who have previous history or present illness of cardiovascular disease, nephritis, hepatitis, pancreatitis, and so on.
6)Subjects who have previous history of serious disability of liver, kidney, heart, lung, blood, and so on.
7)In principle, subjects who have comorbidity and previous history of digestive system.
8)Subjects who have previous history or present illness of epilepsy.
9)Subjects who systolic blood pressure is 140 mmHg or more, or diastolic blood pressure is greater than or equal to 90 mmHg at rest.
10)Subjects who are ingesting alcohol in excessive (alcohol in terms of 60 g or more per day).
11)Subjects who are a blood donation of more than 200 mL in the past one month, or more than 400 mL in the past three months.
12)Subject who have a smoking habit.
13)Subjects who are participating in other clinical trial or three months has not elapsed after joining other clinical trials.
14)Subjects who were deemed inappropriate to participate in the study by the investigator.
48
1st name | |
Middle name | |
Last name | Osami Kajimoto |
Osaka City University Graduate School of Medicine
Department of Medical Science on Fatigue
1-4-3, Asahi-machi, Abeno-ku, Osaka, Osaka
06-6645-6171
kajimoto@med.osaka-cu.ac.jp
1st name | |
Middle name | |
Last name | Aya Horiuchi |
Soiken Inc.
R&D Division
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
06-6871-8888
horiuchi_aya@soiken.com
Soiken Inc.
FANCL Corporation
Profit organization
NO
医療法人弘正会ふくだ内科クリニック(大阪府)
2016 | Year | 08 | Month | 30 | Day |
Unpublished
Terminated
2016 | Year | 08 | Month | 20 | Day |
2016 | Year | 10 | Month | 16 | Day |
2016 | Year | 08 | Month | 29 | Day |
2017 | Year | 06 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027438
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