Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059219) titled 'Fermented Whey Protein Study' on Sept. 29.

Study Type: Interventional

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

Primary Sponsor: Institute - Ritsumeikan University

Condition: Condition - Not applicable: Healthy male volunteers Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To elucidate the time course changes in plasma amino acid concentrations in humans after acute ingestion of fermented whey protein. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Whey protein (FrieslandCampina). A single oral ingestion of 13.5 g protein dissolved in 200 mL water on one study day (once daily, one day only). The trial is conducted in a crossover design with approximately one week washout between interventions. Interventions/Control_2 - Fermented whey protein (Biotis Fermentis, FrieslandCampina). A single oral ingestion of 13.5 g protein dissolved in 200 mL water on one study day (once daily, one day only). The trial is conducted in a crossover design with approximately one week washout between interventions.

Eligibility: Age-lower limit - 18 years-old = Gender - Male Key inclusion criteria - Healthy males aged 18-40 years or 65-79 years Those judged to have no health problems based on a screening examination conducted by the principal investigator or co-investigators Individuals who have received a full explanation of the study purpose and procedures, and who have provided written informed consent Key exclusion criteria - Individuals with milk allergy Individuals with other food allergies Individuals who habitually perform resistance training Individuals who habitually consume amino acid or protein supplements Individuals with hepatitis B or C virus infection, or suspected infection Individuals with a history of cardiovascular disease, such as heart disease or hypertension Individuals taking anticoagulant medications (e.g., warfarin) Any other individuals deemed unsuitable by the principal investigator or study physician Target Size - 24

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 06 Month 24 Day Date of IRB - 2025 Year 07 Month 29 Day Anticipated trial start date - 2025 Year 08 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067718

Disclaimer: Curated by HT Syndication.