Tokyo, May 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058348) titled 'Effect of oral lycopene intake on vascular endothelial function: a systematic review with a meta-analysis' on May 15.

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 verify the following research question "In healthy adults, does oral intake of a test substance containing lycopene improve vascular endothelial function compared to oral intake of a test substance that does not contain lycopene, or has an extremely low concentration of lycopene compared to the intervention group, or no intervention at all?" Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (PI(E)COS) 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 form and amount)

Exposure: Oral intake of test foods containing lycopene (regardless of form and amount)

Comparison (for interventional studies): 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

Comparison (for observational studies): Oral intake of test foods that do not contain lycopene is the control. In the case of the stratified analysis by amount of the oral intake of foods containing lycopene, the group with the lowest lycopene intake is used as the control.

Outcome measurement: The measurements by FMD, RH-PAT, and plethysmograph are the outcomes. Measurements by FMD is the primary outcome. The measurements by RH-PAT and plethysmograph are the secondary outcomes. The measurements at the endpoint 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. Cohort study and case-control study are the study designs of observational studies. Cross-sectional study is excluded because it is difficult to explain causal relationships.

(Language) Eligibility is not restricted by language. Key exclusion criteria - Studies that do not aim at evaluating vascular endothelial function, studies assessing the safety of excessive intake by short-term intake of lycopene, conference proceedings (i.e. conference abstracts) and unpublished materials where detailed cross-checking is impossible are excluded. Other grey literature is excluded because it is difficult to confirm its appropriateness.

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 04 Month 23 Day Date of IRB - 2025 Year 04 Month 23 Day Anticipated trial start date - 2025 Year 07 Month 04 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066703

Disclaimer: Curated by HT Syndication.