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A study to evaluate the effects of test food on energy metabolism

A study to evaluate the effects of test food on energy metabolism - A study to evaluate the effects of test food on energy metabolism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052678
Enrollment
6
Registered
2023-11-02
Start date
2023-11-06
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 volunteers

Interventions

Intake of test food for one week (once a day, 7 tablets) Intake of placebo for one week (once a day, 7 tablets)

Sponsors

Kobayashi Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Healthy male subjects whose age of 20 years or more and 29 years or less 2) Subjects whose BMI is 18.5 kg/m2 or more and less than 23.0 kg/m2 3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent

Exclusion criteria

Exclusion criteria: 1) Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2) Subjects having a medical history of chest pain or syncope 3) Subjects having a subjective symptom of low back pain, arthralgia, lumber hernia, disease of lower limbs or palpitations 4) Subjects having the possibility of developing allergic symptoms by the test food or the specified pre-examination meals 5) Subjects using medicines or quasi-drugs having the effect on energy metabolism 6) Subjects regularly taking Foods for Specified Health Uses or Foods with Function Claims labeled the effect on energy metabolism 7) Subjects having a smoking habit 8) Subjects implanted metals (e.g., cardiac pacemaker) in the body 9) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 10) Subjects deemed unsuitable by the investigator

Design outcomes

Primary

MeasureTime frame
fat consumption by respiratory gas analysis

Secondary

MeasureTime frame
energy expenditure, carbohydrate consumption and respiratory quotient by respiratory gas analysis

Countries

Japan

Contacts

Public ContactTomohiro Sugino

Soiken Inc. R&D Division

sugino@soiken.com06-6871-8888

Outcome results

None listed

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