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A study for evaluating the effects of oral intake of food containing plants extract on cold sensitivity of periphery. A placebo-controlled, randomized, double-blind, cross-over trial.

A study for evaluating the effects of oral intake of food containing plants extract on cold sensitivity of periphery. A placebo-controlled, randomized, double-blind, cross-over trial. - A study for evaluating the effects of oral intake of food containing plants extract on cold of periphery.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027328
Enrollment
12
Registered
2017-05-12
Start date
2017-05-15
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

Test food with plants extract (single ingestion) - washout period - placebo food without plants extract (single ingestion) Placebo food without plants extract (single ingestion) - washout period - tes

Sponsors

Lotte Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1) Subjects who are sensitive to cold (2) Females from 20 to 49 years of age (3) Subjects giving written informed consent

Exclusion criteria

Exclusion criteria: (1) Individuals who are under treatment or have a history of Cardiovascular disease (including cardiac infarct, arrhythmia, high-blood pressure, ischemic cardiac disease, aneurysm of aorta, dissection of the aorta, diabetes, renal failure, low-blood pressure etc. ) (2) Individuals who are currently suffering from some disease and undergoing drug treatment (3) Individuals taking drugs (including aspirin and warfarin etc.), health foods and foods with function claims (including hesperidin and ginger etc.) in common use, which influence blood flow (4) Shift worker at midnight and irregular time zones (5) Individuals presenting known food allergy (6) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period (7) Individuals who are judged as unsuitable for the study by the investigator

Design outcomes

Primary

MeasureTime frame
Skin surface temperature of fingertip following the exposure to cold water stress. Blood flow of fingertip following the exposure to cold water stress.

Secondary

MeasureTime frame
Feeling questionnaire.

Countries

Japan

Contacts

Public ContactKeishiro Yoshida

Lotte Co., Ltd. Central Laboratory, Food material development section

yoshida_keishirou@lotte.co.jp048-837-0187

Outcome results

None listed

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