Tokyo, Aug. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058700) titled 'A double-blind trial examining the effect of lactic acid bacteria on N1487-7 lowering cholesterol levels' on Aug. 20.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Miura Clinic, Medical Corporation Kanonkai
Condition:
Condition - Healthy individuals
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effect on lowering cholesterol levels of ingestion of test food for 12 consecutive weeks, using placebo as a control.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Intake of test food for 12 consecutive weeks
Interventions/Control_2 - Intake of control placebo for 12 consecutive weeks
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) Healthy males and females from 20 to 64 years old
(2) Participants with LDL cholesterol levels of 120-139 mg/dL or 140-159 mg/dL. However, less than half of the participants should have140-159 mg/dL.
(3) Participants who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Key exclusion criteria - (1) Participants with a history of hypercholesterolemia, psychiatric disorders, diabetes, liver disease, kidney disease, digestive disorders, cardiac diseases, respiratory diseases, peripheral vascular disorders, or other serious diseases
(2) Participants who undergo surgery on the digestive tract
(3) Participants with abnormal liver and kidney function tests
(4) Participants with diseases currently being treated
(5) Participants who are allergic to food and drugs
(6) Participants with anemia symptoms
(7) Female participants wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female participants
(8) Participants who play intense sports and participants who are on a diet
(9) Participants with extremely irregular eating habits
(10) Participants who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period
(11) Participants who are continuously receiving treatment with pharmaceuticals (including OTC and prescription drugs)
(12) Participants who drink more than 60 g of average daily pure alcohol
(13) Participants who smoke an average of 21 or more cigarettes a day
(14) Participants who are participating in or will participate in other clinical trials at the start of this study.
(15) Other participants judged by the investigator or the investigator to be inappropriate for the examination
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 23 Day
Date of IRB - 2025 Year 07 Month 30 Day
Anticipated trial start date - 2025 Year 09 Month 11 Day
Last follow-up date - 2025 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067108
Disclaimer: Curated by HT Syndication.