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.
Conditions
Interventions
None listed
Sponsors
Maruzen Pharmaceuticals Co., LTD.
Professor Hiroharu Kamioka, Tokyo University of Agriculture
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is the amount of serum oxidized LDL-cholesterol. | — |
Countries
Japan
Contacts
Public ContactShingo Ikeuchi
Maruzen Pharmaceuticals Co.,Ltd. Research & Development div.
Outcome results
None listed