Tokyo, Jan. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060307) titled 'Effects of intake of capsules containing sialylglycopeptide on blood D-amino acid concentration in humans -open study-' on Jan. 9.

Study Type: Interventional

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

Primary Sponsor: Institute - Megmilk Snow Brand Co., Ltd.

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

Objective: Narrative objectives1 - To examine the effects of intake of capsules containing milk-derived sialylglycopeptide on blood D-amino acid concentration Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake of test food for 4 weeks (once a day, 6 capsules)

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1) Males and females aged 20-64 years 2) Those who received a sufficient explanation of the study's objectives and procedures, fully understood the information, voluntarily agreed to participate, and were able to personally sign a written informed consent form Key exclusion criteria - 1) Persons with a medical history of or receiving medical treatment for the following diseases: diabetes, or renal, hepatic, cardiovascular, thyroid, adrenal, or metabolic diseases 2) Persons regularly taking medicines for chronic diseases 3) Persons regularly consuming foods containing lactic acid bacteria, bifidobacterium, oligosaccharide, live microbes, or fermented food 4) Persons taking supplements, consuming a diet, or taking medicines that affect fatigue or sleep 5) Persons working day-night shifts, irregular shifts, or those working night shifts twice during the study period 6) Persons with irregular holidays 7) Persons engaging in manual labor such as heavy cargo transport 8) Persons smoking 21 or more cigarettes a day 9) Persons regularly consuming high-caffeine drinks (equivalent to seven or more cups of coffee a day) 10) Persons with allergic symptoms to certain foods 11) Persons with substance dependence, alcohol use disorder, or those with a medical history of these disorders 12) Persons who are pregnant or lactating, or intending to become pregnant during the study period 13) Persons who have donated more than 200 ml of blood within 1 month, more than 400 ml within 3 months, or plasma or platelet within 2 weeks prior to providing informed consent section for this study 14) Persons who took part in another clinical study within 3 months prior to the start of the present study or who are currently taking part in or intending to take part in another clinical study during the study period 15) Persons deemed unsuitable by the investigator Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 15 Day Date of IRB - 2025 Year 11 Month 15 Day Anticipated trial start date - 2026 Year 02 Month 07 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068860

Disclaimer: Curated by HT Syndication.