Clinical Trial: A Study on the Effects of Continued Consumption of the Investigational Food on LDL-C and Blood Lipid-Related Metabolism, Including Exploratory Indicators - Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Comparison - (Japan)

Tokyo, Nov. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063228) titled 'A Study on the Effects of Continued Consumption of the Investigational Food on LDL-C and Blood Lipid-Related Metabolism, Including Exploratory Indicators' on Nov. 13.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - IMEQRD Co. Ltd.

Condition: Condition - Healthy adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the cholesterol-lowering effect, primarily on LDL-C, of 12 weeks of continuous intake of the test food in adults aged 20 to under 75 years with LDL-C levels between 120 and 140 mg/dL. The study also aims to observe changes in blood lipid parameters, lipoprotein-related markers, risk indicators associated with blood lipids, aging markers, and other exploratory endpoints. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Consume one bottle (280 mL) of the test food every morning for 12 weeks. Interventions/Control_2 - Consume one bottle (280 mL) of the placebo food every morning for 12 weeks.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Age: 20 years or older, under 75 years 2. Japanese nationality, male or female 3. BMI >=18.5 kg/m^2 and =120 mg/dL and =40 g pure alcohol/day) 9. Habitual excessive smoking (>=21 cigarettes/day) 10. Shift workers with night shifts 11. Plans to significantly change lifestyle (diet, sleep, exercise) during study period (e.g., long trips) 12. Pregnant, breastfeeding, or planning pregnancy during study period 13. Participating in other clinical trials of drugs or health foods, within 4 weeks after completion, or planning to participate in another trial after consent 14. Deemed unsuitable for the study by the principal or sub-investigator Target Size - 106

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 15 Day Date of IRB - 2026 Year 09 Month 29 Day Anticipated trial start date - 2027 Year 01 Month 11 Day Last follow-up date - 2027 Year 04 Month 09 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072369

Disclaimer: Curated by HT Syndication.