UMIN-ICDS Clinical Trial

Public title

Effect of oral lycopene intake on vascular endothelial function: a systematic review with a meta-analysis

Acronym

Effect of oral lycopene intake on vascular endothelial function: a systematic review with a meta-analysis

Scientific Title

Effect of oral lycopene intake on vascular endothelial function: a systematic review with a meta-analysis

Scientific Title:Acronym

Effect of oral lycopene intake on vascular endothelial function: a systematic review with a meta-analysis

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Basic objectives -Others

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Measurements by flow mediated dilation (FMD) (%)

Key secondary outcomes

Measurements by reactive hyperemia peripheral arterial tonometry (RH-PAT) (ratio of amplitude), plethysmograph (mL/min/100 g)

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

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.

Target sample size

Name of lead principal investigator

1st name	Shingo
Middle name
Last name	Takahashi

Organization

KAGOME CO., LTD.

Division name

Diet and Well-being Research Institute

Zip code

3292762

Address

17 Nishitomiyama, Nasushiobara-shi, Tochigi

TEL

0287-36-2935

Email

g167_0@kagome.co.jp

Name of contact person

1st name	Kazutaka
Middle name
Last name	Yoshida

Organization

KAGOME CO., LTD.

Division name

Diet and Well-being Research Institute

Zip code

3292762

Address

17 Nishitomiyama, Nasushiobara-shi, Tochigi

TEL

0287-36-2935

Homepage URL

Email

g167_0@kagome.co.jp

Institute

KAGOME CO., LTD.

Institute

Department

Personal name

Organization

KAGOME CO., LTD.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kagome Co.,LTD. Research Ethics Review Committee

Address

3-21-1 Nihonbashihamacho. chuo-ku, Tokyo

Tel

03-5623-8501

Email

Takuji_Hayakawa@kagome.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

05

Month

15

Day

URL releasing protocol

https://zenodo.org/records/15788929

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

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

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(Search strategy)
Seven databases and research registries will be searched by a searcher. FFC database will be searched and omitted related studies will be added to the review. The studies found by other methods will be added.

(Selection and data collection)
It will be conducted based on eligibility criteria independently by two reviewers. Disagreements will be resolved by discussion between the reviewers.

(Risk of bias)
It will be assessed independently by two reviewers using modified check list (13 items) of Cochrane Handbook for interventional trials. Disagreements will be resolved by discussion between the reviewers. The agreement rate and the kappa coefficient will be calculated. Studies with a high risk of bias will not be adopted.

(Indirectness)
It will be evaluated independently by two reviewers.

(Data synthesis)
A meta-analysis will be performed using RevMan Web only in the absence of heterogeneity. Studies with missing data will be excluded if no data is available by contacting the author. If not suitable for integration, a qualitative assessment will be carried out. Sensitivity analysis and sub-group analysis will be performed as needed based on the results of selected articles.

(Imprecision)
It will be assessed based on the total number of participants.

(Inconsistency)
It will be evaluated by the I square value and statistical test in a meta-analysis.

(Publication bias)
It will be assessed from Funnel plot and the reporting status of studies registered in research registries.

(Review team)
KY, YN, ST (KAGOME CO., LTD.)
SS, HK (Others)

Registered date

2025

Year

07

Month

02

Day

Last modified on

2026

Year

05

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066703