Tokyo, Dec. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060041) titled 'Photoprotective effects of oral lycopene intake against ultraviolet radiation: a systematic review' on Dec. 11.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - KAGOME CO., LTD.

Condition: Condition - Healthy adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine whether, in healthy adults, oral intake of a test substance containing lycopene provides photoprotective effects against ultraviolet (UV) exposure compared with oral intake of a non-lycopene product, a product containing an extremely low concentration of lycopene, or no intervention. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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. Key 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 Conference proceedings (such as meeting abstracts) and unpublished materials, for which detailed verification is not feasible, will be excluded.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.

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 05 Day Anticipated trial start date - 2026 Year 02 Month 02 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068663

Disclaimer: Curated by HT Syndication.