Healthy adults
Conditions
Interventions
None listed
Sponsors
KAGOME CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (PICOS) Participant: Healthy adults without illness (excluding minor under 18 years old, pregnant women, those planning to become pregnant, and lactating women) Intervention: Oral intake of test foods containing lycopene, regardless of the form, dosage, or duration of intake. Comparison: Oral intake of test foods that does not contain lycopene, or has an extremely low concentration of lycopene compared to the intervention, or no intervention at all. Outcome measurement: The erythema (a* value) at the UV-irradiated site is the primary outcome. The Minimal Erythema Dose (MED), the L* value at the UV-irradiated site, the Erythema Index at the UV-irradiated site, and D30 are the secondary outcomes. The measurements at the final evaluation time point will be used as outcomes. Study design: Randomized parallel group-controlled trial (RCT-P), randomized crossover-controlled trial (RCT-C), quasi-randomized parallel group-controlled trial (qRCT-P), quasi-randomized crossover-controlled trial (qRCT-C), non-randomized parallel group-controlled trial (nonRCT-P), non-randomized crossover-controlled trial (nonRCT-C), and non-randomized controlled trial are the study designs of clinical trials. (Language) Eligibility is not restricted by language.
Exclusion criteria
Exclusion criteria: Studies that do not aim to evaluate photoprotective effects against UV exposure will be excluded. Studies that assess the safety of excessive lycopene intake by administering large amounts of lycopene over a short period will also be excluded. Conference proceedings (such as meeting abstracts) and unpublished materials, for which detailed verification is not feasible, will be excluded. In addition, other forms of grey literature will be excluded because their appropriateness cannot be adequately ascertained.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erythema (a* value) at the UV-irradiated site | — |
Secondary
| Measure | Time frame |
|---|---|
| Minimal Erythema Dose (MED), L* value at the UV-irradiated site, Erythema Index at the UV-irradiated site, and D30 | — |
Countries
Japan
Contacts
Public ContactYuichiro Nakazawa
KAGOME CO., LTD. Diet and Well-being Research Institute
Outcome results
None listed