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A Study on the Effect of Plant-Derived Product on Body Temperature -A Randomized, Double-blind, Placebo-controlled, Cross-over Study-

A Study on the Effect of Plant-Derived Product on Body Temperature -A Randomized, Double-blind, Placebo-controlled, Cross-over Study- - A Study on the Effect of Plant-Derived Product on Body Temperature

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045227
Enrollment
25
Registered
2021-08-23
Start date
2021-08-24
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

Plant-derived products, single ingestion. Wash out. Placebo products, single ingestion. Placebo products, single ingestion. Wash out. Plant-derived products, single ingestion.

Sponsors

TOYO SHINYAKU Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy males and females aged 20 to 64 years-old. 2) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: Subjects (who) 1) contract and/or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, and/or other metabolic disease). 2) have a chronic disease and use medications. 3) have a history and/or a surgical history of digestive disease affecting digestion and absorption. 4) may have allergy to test foods. 5) use medications affecting body temperature. 6) can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting body temperature during test periods. 7) are planning to become pregnant after informed consent, pregnant or lactating. 8) are under treatment for or have a history of drug addiction and/or alcoholism. 9) are shift worker and/or midnight-shift worker. 10) had been conducted an operation or beauty treatment on the test spot in the past 6 months. 11) are participating and/or are planning to participate in other clinical studies that affect this study after informed consent. 12) are judged unsuitable for the current study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Core body temperature

Secondary

MeasureTime frame
Body surface temperature (only male subjects are measured)

Countries

Japan

Contacts

Public ContactNobutaka Kusaba

TOYO SHINYAKU Co., Ltd. Clinical and analytical research center

gakujutsu@toyoshinyaku.co.jp0942-81-3555

Outcome results

None listed

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