Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063123) titled 'Evaluation of the Blood Kinetics of Maslinic Acid Following Consumption of a Food Containing Olive Fruit Extract' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Dose comparison
Primary Sponsor:
Institute - MIS Co.,Ltd.
Condition:
Condition - Healthy subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study will evaluate the blood Blood Kinetics of maslinic acid following consumption of foods containing olive fruit extract among Japanese men aged 40 to 59.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Single intake of test food A
Interventions/Control_2 - Single intake of test food B
Eligibility:
Age-lower limit - 40
years-old
Gender - Male
Key inclusion criteria - 1.Japanese male and female subjects between 20 and 60 years of age at the time of consent.
2.Subjects who can have multiple blood draws.
3.Subjects who lead a regular life (subject who eat three meals a day at almost regular intervals).
4.Healthy subjects.
5.Subjects who have received a full explanation of the purpose and content of the study, have the ability to consent, understand the study well, and have volunteered to participate in the study and have agreed to participate in the study in writing.
Key exclusion criteria - 1.Subjects who are currently receiving medication or outpatient treatment for some serious disease.
2.Subjects who are currently undergoing exercise or diet therapy under the supervision of a physician.
3.Subjects who may develop allergies to the test food.
4.Subjects who have a current or history of drug dependence or alcohol dependence.
5.Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders, or have a history of mental disorders in the past.
6.Subjects who have irregular rhythm of life due to night work or shift work.
7.Subjects who are with extremely irregular eating, sleeping, or other habits.
8.Subjects who have an extremely unbalanced diet.
9.Subjects who have or have had serious diseases such as brain diseases, malignant tumors, immune diseases, diabetes, liver diseases (hepatitis), kidney diseases, heart diseases,gastrointestinal diseases, etc., thyroid diseases, adrenal diseases, and other metabolic diseases.
10.Subjects who use of health foods, supplements, and medications within one month retroactive to the date consent was obtained.
11.Subjects who have participated in other clinical trials (research) within 3 months retrospectively from the date of obtaining consent, or those who have plans to participate in other clinical trials (research) during the study period
12.Subjects who have collected more than 200 mL of blood within 1 month or 400 mL within 3 months prior to the date of obtaining consent.
13.Subjects who have difficulty in complying with the recording of various questionnaires.
14.Other subjects who are judged unsuitable as subjects by the principal investigator.
Target Size - 6
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 10 Day
Date of IRB - 2026 Year 09 Month 17 Day
Anticipated trial start date - 2026 Year 10 Month 02 Day
Last follow-up date - 2026 Year 10 Month 23 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072186
Disclaimer: Curated by HT Syndication.
