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Effect of supplement on respiratory metabolism. -a randomized, double-blind, placebo-controlled, cross-over study-

Effect of supplement on respiratory metabolism. -a randomized, double-blind, placebo-controlled, cross-over study- - Effect of supplement on respiratory metabolism.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023820
Enrollment
48
Registered
2016-08-30
Start date
2016-10-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteer

Interventions

Measurement of respiratory metabolism in rest and exercise after single oral intake of supplement -&gt
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 -&gt
measurement of respiratory metabolism in rest and exercise after single oral intake of supplement

Sponsors

Soiken Inc.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Fat oxidation

Secondary

MeasureTime frame
Volume of oxygen consumption (VO2) Volume of carbon dioxide output (VCO2) Respiratory quotient Energy expenditure

Countries

Japan

Contacts

Public ContactAya Horiuchi

Soiken Inc. R&D Division

horiuchi_aya@soiken.com06-6871-8888

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026