MedPath

Effect of a Test Food for Ski

Not Applicable
Conditions
/A(healthy adults)
Registration Number
JPRN-UMIN000031284
Lead Sponsor
TES Holdings Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

[1]Individuals using medical products. [2]Individuals with skin disease, such as atopic dermatitis. [3]Individuals with strange skin conditions at measurement points. [4]Individuals who used or applied a drug for treatment of disease in the past 1 month. [5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [6]Individuals who contract or have a history of serious gastrointestinal disease. [7]Individuals with serious anemia. [8]Individuals who are sensitive to test product or other foods, and medical products. [9]Females who aware of rough skin before and after menstruation. [10]Individuals who are or are possibly pregnant, or are lactating. [11]Individuals who have an addiction to alcohol or a mental illness. [12]Individuals who are a smoker. [13]Individuals with possible changes of life style, such as working a night shift, during the test period. [14]Individuals who will develop seasonal allergy symptoms like hay fever. [15]Individuals who are excessively negligent of skin care. [16]Individuals who cannot avoid daylight exposure during the test period (including winter sports like ski and snowboard). [17]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. [18]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [19]Individuals who had been conducted an operation on the test spot. [20]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [21]Individuals who participated in other clinical studies in the past 3 months. [22]Individuals who are or whose family is engaged in healthy or functional foods, or cosmetics. [23]Individuals judged inappropriate for the study by the principal.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
[1]Skin quality evaluation (skin moisture content, Transepidermal water loss, observation for skin condition by dermatologists) (before and afte ingestion).
Secondary Outcome Measures
NameTimeMethod
*Secondary outcomes [1]Blood phenol level (before and afte ingestion). [2]Blood p-cresol level (before and afte ingestion). [3]Subject's diary (From the first day of ingestion of a test material to the last day of the test). [4]Questionnaire of physical feeling (before and afte ingestion). *Safety [1]Hematologic test (before and afte ingestion). [2]Blood biochemical test (before and afte ingestion). [3]Urine analysis (before and afte ingestion). [4]Doctor's questions (before and afte ingestion).
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