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A Pilot Study on the Relationship Between Protein Metabolism Indicators and Nutritional Status in Healthy Adult Males: An Open-Label, Single-Arm Trial

A Pilot Study on the Relationship Between Protein Metabolism Indicators and Blood Components in Healthy Adult Males: An Open-Label, Single-Arm Trial - A Pilot Study on the Relationship Between Protein Metabolism Indicators and Blood Components

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059693
Enrollment
14
Registered
2025-11-07
Start date
2025-11-07
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 Adult Males

Interventions

Intake of standardized meals

Sponsors

Otsuka Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Individuals who provided written informed consent to participate in this trial. 2) Healthy adult males aged 20 to 65 years. 3) Individuals who are able to follow the investigator's instructions and adhere to the scheduled intake of the 15N-Glycine and the standardized meals, blood sampling, urine collection, and maintenance of rest.

Exclusion criteria

Exclusion criteria: 1) Individuals judged by the principal investigator to be ineligible for this trial based on the results of the preliminary medical examination. 2) Individuals who showed a high-sensitivity CRP level of >= 0.2 mg/dL or an albumin level of < 3.8 g/dL at the time of the preliminary medical examination. 3) Individuals with diseases of the gastrointestinal, cardiovascular, or endocrine systems, or with a history of such conditions, as well as those who regularly take medications for the treatment of these diseases, who are judged by the principal investigator to be ineligible for this trial. 4) Individuals with food allergies. 5) Individuals who have had 200 mL or more of whole blood collected within the past 4 weeks, or 400 mL or more within the past 12 weeks prior to the first blood sampling. 6) Individuals who are currently participating in another trial or are scheduled to participate in another trial. 7) Individuals who are judged to be ineligible for this trial for other reasons by the principal investigator or the study director.

Design outcomes

Primary

MeasureTime frame
Relationship between protein metabolism indicators and blood component concentrations.

Countries

Japan

Contacts

Public ContactShoichiro Inoue

Otsuka Pharmaceutical Co., Ltd. Advanced Research Institute for Core Science

Inoue.Shoichiro@otsuka.jp+81-77-519-0111

Outcome results

None listed

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