Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059192) titled 'A study to examine the effects of intake of a capsule containing multi-ingredient(FD-2553) on fat metabolism' on Nov. 30.

Study Type: Interventional

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

Primary Sponsor: Institute - Maruzen Pharmaceuticals Co., Ltd

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

Objective: Narrative objectives1 - To examine the effects of intake of the test food on fat metabolism Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Single intake of the test food -> washout period (1 week) -> Single intake of the placebo Interventions/Control_2 - Single intake of the placebo -> washout period (1 week) -> Single intake of the test food

Eligibility: Age-lower limit - 20 years-old = Gender - Male Key inclusion criteria - 1)Male whose age of 20 to 45 2)Person whose BMI of 18.5 kg/m2 or more and less than 25.0 kg/m2 3)Person with no regular exercise habit of twice a week or more 4)Person receiving sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent 5)Person who can have examinations at the specified date Key exclusion criteria - 1)Person receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2)Person having a medical history of chest pain or syncope 3)Person having low back pain, arthralgia, lumber hernia, disease of lower limbs or palpitations 4)Person who may have allergic symptoms to the test food or standardized diet 5)Person having moderate or more allergic rhinitis 6)Person who regularly take medicines and quasi-drugs that affect energy metabolism 7)Person who regularly take Foods with Function Claims indicating functions that affect energy metabolism 8)Person who have a smoking habit (including heated tobacco and electronic cigarettes) 9)Person who consume excessive alcohol (equivalent to an average of 40 g or more of pure alcohol per day) 10)Person who restrict carbohydrates intake 11)Person working night shift or day-night shift 12)Person who have donated more than 200 ml of blood within 1 month, or more than 400 ml within 3 months prior to the start of the present study 13)Person who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 14)Person deemed unsuitable by the investigator Target Size - 24

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 16 Day Date of IRB - 2025 Year 08 Month 16 Day Anticipated trial start date - 2025 Year 12 Month 04 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=R000067624

Disclaimer: Curated by HT Syndication.