UMIN-CTR Clinical Trial

Basic information
Public title	The effects of olive-derived hydroxytyrosol intake on LDL-cholesterol oxidative suppression - A systematic review.
Acronym	A systematic review of olive-derived hydroxytyrosol.
Scientific Title	The effects of olive-derived hydroxytyrosol intake on LDL-cholesterol oxidative suppression - A systematic review.
Scientific Title:Acronym	A systematic review of olive-derived hydroxytyrosol.
Region	Japan

Condition
Condition	Adult volunteers who are healthy or have no more than one mild health disorder (pertaining to blood glucose level, blood pressure or plasma lipid) which is within boundary range and not exceeding boundary range.
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The object of this review is to evaluate the suppressive effect on LDL-cholesterol oxidization by intake of food containing olive-derived hydroxytyrosol compared with the intake of placebo food.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary outcome is the amount of serum oxidized LDL-cholesterol.
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Participants: Healthy*1 or mild illness*2 adult volunteers Intervention: One-time or continuous intake of food containing olive-derived hydroxytyrosol*3 Comparison: Intake of placebo food Outcome: Amount of serum oxidized LDL-cholesterol Study design: Randomized comparison test (randomized, double-blind, placebo-controlled parallel group trial or randomized, double-blinded cross-over trial) The literature to be included will be made up of original papers, information on clinical trial registered databases, abstracts, and grey literature. Although the language of target literature for this research will not be limited, the keywords used in the literature search will be in English or Japanese only. Hand-search will also be conducted on some scientific journals. *1: Studies with subjects aged 18 or 19 may be subject to inclusion in the study if the number of such subjects is less than half of the total number of adults included in the study, and if approval of the Ethics Review Committee is gained. *2: Subjects whose BMI is less than 30kg/m2 and have only one of the following- Mild hyperlipidemia (LDL-cholesterol: 140~159 mg/dL and/or TGs: 150~199 mg/dL), Stage 1 hypertension (diastolic blood pressure: 140~159 mmHg and/or systolic blood pressure: 90~99 mmHg), or Mild hyperglycemia (fasting blood glucose level: 115~125mg/dL and/or casual blood glucose level: 140~199mg/dL). *3: The foods which have special dosage forms or go through special digestion/ absorption pathway are excluded.
Key exclusion criteria	Literature which does not meet key inclusion criteria will be excluded. Subjects who are suffering from illness, overweight (BMI is 30kg/m2 or more), planning or currently pregnant or breastfeeding, and children (persons under 18 years), will be excluded from this study. If subjects have conditions which exceed limits: Mild hyperlipidemia, Stage 1 hypertension, or Mild hyperglycemia, and/or have more than one of these conditions, the subject is deemed as having an illness and excluded.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Ikeuchi
Organization	Maruzen Pharmaceuticals Co.,Ltd.
Division name	Research & Development div.
Zip code	729-3102
Address	1089-8, Sagata, Shinnichi-cho, Fukuyama city, Hiroshima, Japan
TEL	0847-52-6262
Email	s-ikeuchi@maruzenpcy.co.jp

Public contact
Name of contact person	1st name Shingo Middle name Last name Ikeuchi
Organization	Maruzen Pharmaceuticals Co.,Ltd.
Division name	Research & Development div.
Zip code	729-3102
Address	1089-8, Sagata, Shinnichi-cho, Fukuyama city, Hiroshima, Japan
TEL	0847-52-6262
Homepage URL
Email	s-ikeuchi@maruzenpcy.co.jp

Sponsor
Institute	Maruzen Pharmaceuticals Co., LTD.
Institute
Department

Funding Source
Organization	Maruzen Pharmaceuticals Co., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Professor Hiroharu Kamioka, Tokyo University of Agriculture
Name of secondary funder(s)

IRB Contact (For public release)
Organization	N/A
Address	N/A
Tel	-
Email	-

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://www.pieronline.jp/content/article/0386-3603/48120/2073
Number of participants that the trial has enrolled	249
Results	We included three articles as result of searching on databases and judging with including criteria. The articles reported result of randomized double-blinded placebo-controlled crossover study which evaluated effect of intake olive derived hydroxytyrosol on blood oxLDL concentrate. We judged heterogeneity of these articles were low and performed meta-analysis. We concluded intake olive derived hydroxytyrosol is significantly decrease blood oxLDL concentrate.
Results date posted	2021 Year 04 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 12 Month 20 Day
Baseline Characteristics	Healthy European adults
Participant flow	Refer each article.
Adverse events	None
Outcome measures	Blood oxLDL
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 04 Month 06 Day
Date of IRB	2020 Year 04 Month 06 Day
Anticipated trial start date	2020 Year 04 Month 07 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

(Search) Searcher B will search 7 databases and 3 internet search engines for studies from the beginning of each database to the search date. Reviewer A and C will search journals which are possessed in Maruzen Pharmaceuticals Co., Ltd. (Data extraction) In order to make the final selection of studies for the review, reviewer A and C will independently apply all criteria to the full text of articles that have passed the first eligibility screening. Disagreement and uncertainties will be resolved by discussion with researcher D. In addition, reviewer A will calculate agreement rate and kappa coefficient. (Risk of bias assessment and Indirectness evaluation) Reviewer A and C will independently assess the quality of articles and evaluate the indirectness of articles. A full quality appraisal of these papers will be made using modified check list (12 items) of Cochrane Handbook for interventional trials. Disagreement and uncertainties will be resolved by discussion with researcher D. (Imprecision assessment) Imprecision will be assessed based on total number of participants in all included studies. (Inconsistency evaluation) If there is only an eligible article, inconsistency will be evaluated as `unknown`. If there are two or more than eligible articles, inconsistency will be evaluated according by a statistical test (the value of I2) for heterogeneity of effect estimates in a meta-analysis. When meta-analysis is not able to perform, inconsistency will be evaluated according to rate of `significantly effective` articles. (Meta-analysis) Only when no heterogeneity will be found in multiple randomized controlled trials, reviewer A and C will perform a meta-analysis using RevMan 5. (Protocol) The protocol of this study cannot be completely explained here because of this site's mention limitation. And it is archived at organization of "Principal investigator". If you want to get full protocol, contact "Contact person" directly.

Management information
Registered date	2020 Year 04 Month 06 Day
Last modified on	2021 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045701