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Placebo-controlled double blinded parallel trial for safety and efficacy evaluation of drink containing with a plant-derived product and carnosine

Placebo-controlled double blinded parallel trial for safety and efficacy evaluation of drink containing with a plant-derived product and carnosine - Safety and efficacy evaluation of drink with a plant-derived product and carnosine

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018783
Enrollment
60
Registered
2015-08-26
Start date
2015-08-26
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

None listed

Interventions

One drink with plant-derived product and carnosine every day for eight weeks One drink without plant-derived product and carnosine every day for eight weeks

Sponsors

Suntory Global Innovation Center Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy males and females aged 20 to less than 65 years old. 2) Top 60 people detected as high stressor 3) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: 1) Subjects who take continuous medical treatment. 2) Subjects who have systolic blood pressure less than 90 mmHg. 3) Subjects who are pregnant or have possibility to bocome pregnant or planning to become pregnant during the study or breast-feeding woman. 4) Subjects who donated 200 mL of blood and/or blood components within the last one month prior to the current study. 5) Male subjects who donated 400 mL of blood within the last three months prior to the current study. 6) Female subjects who donated 400 mL of blood within the last four months prior to the current study. 7) Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added. 8) Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added. 9) Subjects who are participating in other clinical studies, or who finished clinical study within three months. 10) Subjects who are contracting heart disease, liver disease, kidney disease and digestive disease. 11) Subjects who have contracted a disease in circulatory organs. 12) Subjects who have allergic reaction to drug medicine and food. 13) Subjects who drink alcohol or smoke a lot. 14) Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift. 15) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results. 16) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Number of adverse effects Stress reaction

Secondary

MeasureTime frame
Number of adverse events Proteins and chemicals in blood Intestinal bacterial flora analysis

Countries

Japan

Contacts

Public ContactJiro Takano

Suntory Global Innovation Center Ltd. Innovation Development Department

Jiro_Takano@suntory.co.jp050-3182-0598

Outcome results

None listed

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