Healthy adults
Conditions
Interventions
None listed
Sponsors
KAGOME CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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the safety of excessive intake by short-term intake of lycopene, conference proceedings (i.e. conference abstracts) and unpublished materials where detailed cross-checking is impossible are excluded.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurements by flow mediated dilation (FMD) (%) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurements by reactive hyperemia peripheral arterial tonometry (RH-PAT) (ratio of amplitude), plethysmograph (mL/min/100 g) | — |
Countries
Japan
Contacts
Public ContactKazutaka Yoshida
KAGOME CO., LTD. Diet and Well-being Research Institute
Outcome results
None listed