Tokyo, May 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061416) titled 'A study on the Effects of Continued Consumption of the Test Food on Body Composition' on May 11.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - IMEQRD Co. Ltd.

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

Objective: Narrative objectives1 - To evaluate the effects of 8 weeks of continuous consumption of the test food on body composition in women aged 30 to under 60 years. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - 3 units of the test food are extracted in at least 1050 ml of water, refrigerated for 2 hours, and consumed before or with meals and snacks. The entire amount daily for 8 weeks

Eligibility: Age-lower limit - 30 years-old

Gender - Female Key inclusion criteria - 1.Japanese females with aged 30 and 60 years at the time of informed consent 2.BMI >=25.0 kg/m^2 3.Body fat percentage >= 30% 4.Able to install a dietary survey app on their smartphone and record meals 5.Able to cooperate with full-body photography and consent to publication in academic presentations and media (including TV, magazines, internet, etc.). (Note: published images will show only from the neck down.) 6.Able to enter electronic diaries via smartphone or PC 7.Individuals who have received a thorough explanation of the study, fully understand its purpose and procedures, voluntarily wish to participate, and provide written informed consent Key exclusion criteria - 1.Currently receiving outpatient treatment or medication (including Kampo) for any illness (as-needed use permitted) 2.Currently under dietary or exercise therapy supervised by a physician 3.Current or past history of serious illness 4.Habitually drink three or more cups of black tea per day (>=3 days/week; approx. 350 ml per cup) 5.Underwent or are planning weight loss procedures within the past year 6.Regularly use over-the-counter drugs, quasi-drugs, specified health foods, health foods, or supplements (participation allowed if discontinued after consent and during the study) 7.Current or past drug or food allergies 8.Excessive alcohol consumption (>=40g pure alcohol/day) 9.Excessive smoking (>=21 cigarettes/day) 10.Shift workers with night shifts 11.Planned overseas travel during the study 12.Presence of metal implants due to surgery 13.Use of cardiac pacemaker or other implanted medical devices 14.Claustrophobia 15.Poor health during blood collection 16.Pregnant, breastfeeding, or planning pregnancy during the study 17.Participation in another clinical study within 1 month prior to consent, currently participating, or plans to participate during the study 18.Deemed unsuitable for participation by the principal or sub-investigator Target Size - 5

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 21 Day Date of IRB - 2026 Year 04 Month 28 Day Anticipated trial start date - 2026 Year 05 Month 11 Day Last follow-up date - 2026 Year 07 Month 06 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070270

Disclaimer: Curated by HT Syndication.