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Clinical evaluation of dietary intake of test food in preventing ultraviolet-induced (UV) erythema formation

Clinical evaluation of dietary intake of test food in preventing ultraviolet-induced (UV) erythema formation - Clinical evaluation of dietary intake of test food in preventing ultraviolet-induced (UV) erythema formation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055104
Enrollment
70
Registered
2024-07-29
Start date
2024-09-30
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 adults

Interventions

Test food (190 g/day for 13 weeks) Placebo(190 g/day for 13 weeks)

Sponsors

KAGOME CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy adults between the ages of 20 and less than 60 years old (2) Subjects whose Fitzpatrick skin phototype is type II or type III (3) Subjects who be able to visit the test site on all test days (4) Subjects who have been fully informed of the purpose and content of the research, have the capacity to consent, and have voluntarily volunteered to participate in the research based on a good understanding of the purpose and content of the research, and have agreed to participate in the research in writing (5) Subjects whose dorsal skin can be determined to have UV erythema (6) Subjects who were judged to have MED in the third, fourth, fifth of the six levels of UV radiation at the time of MED judgment before ingestion of the test product

Exclusion criteria

Exclusion criteria: (1) Subjects who are undergoing or requires medical treatment (2) Subjects taking anti-inflammatory medicine at least once a month (3) Subjects who have a medical history for severe disease or abnormality (4) Subjects who have a medical history of alcoholism or drug addiction (5) Subjects with a history or current history of atopic dermatitis (6) Subjects who drink excessive amounts of alcohol on a daily basis (7) Smokers (8) Subjects with photosensitivity disorder (9) Subjects who have symptoms of skin diseases on the evaluation site (10) Subjects who have had allergic reactions to drugs or foods (11) Subjects who take medicine that affect light sensitivity of skin (12) Subjects who have difficulty with taste of test food (13) Subjects who regularly take foods containing a large amount of plant-derived component (14) Subjects who take functional foods containing vitamin C (15) Subjects who take functional foods which has same or similar effect with active ingredient of test food (16) Subjects who use pharmaceuticals effective in the treatment of skin pigmentation and chloasma (17) Subjects who use basic skin care products containing vitamin C (18) Subjects who use skin care products, cosmetics, quasi-drugs that advocate efficacy related to the efficacy examined in this study (19) Subjects who received or plan to receive cosmetic treatment to the evaluated site (20) Subjects who have undergone any special skin care treatment within the past 4 weeks (21) Subjects who have changed and/or started using functional foods and/or sunscreen on the target area within 4 weeks (22) Subjects who exposed to ultraviolet rays beyond daily life (23) Subjects who plan to travel abroad or domestic trip of more than one week (24) Shiftworkers (25) Subjects who are pregnant or breastfeeding (26) Subjects who were involved in another clinical studies within 4 weeks prior to the trial (27) Subjects who are judged to be inappropriate for the study by the principal investigator

Design outcomes

Primary

MeasureTime frame
Absolute value of Minimal erythema dose (MED) after ingestion of test food

Secondary

MeasureTime frame
Amount of change in MED and absolute value and change in skin color (a* and L*), stratum corneum hydration and concentration of serum plant-derived component after ingestion of test food

Countries

Japan

Contacts

Public ContactYuhma Yoshida

DRC CC., LTD. Product Testing Department

yoshida@drc-web.co.jp06-6882-1130

Outcome results

None listed

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