Clinical Trial: Health and Productivity Management program " #Watashi no kinkatsu" : Verification of effects on the gut environment and subjective health by mushroom consumption among employees (Japan)

Tokyo, Jan. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060293) titled 'Health and Productivity Management program " #Watashi no kinkatsu" : Verification of effects on the gut environment and subjective health by mushroom consumption among employees' on Jan. 8.

Study Type: Interventional

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

Primary Sponsor: Institute - HOKUTO Corporation

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

Objective: Narrative objectives1 - As part of our health and productivity management, we will provide employees with opportunities to consume mushrooms and examine the effects of mushroom consumption on fecal short-chain fatty acid levels and various health-related indicators. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Ingestion of mushrooms at 40 g per day for 4 weeks.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1) Male or female employees of HOKUTO Group (HOKUTO Corporation or Hokuto Industry Corporation) who are aged 20 years or older at the time of informed consent. (2) Subjects who receive explanation about the study, are able to understand the contents, and provide written informed consent by themselves. Key exclusion criteria - (1) Individuals who have taken medications that may affect the gut environment (e.g., antibiotics, intestinal regulators, laxatives) within 1 month prior to starting intake of the test food, or who cannot restrict such use during the study. Use for hay fever is permitted. (2) Individuals who are currently participating in another clinical trial of drugs or health foods, within 4 weeks after completing another trial, or who plan to participate in another clinical trial after consenting to this study. (3) Individuals with excessive alcohol consumption. (4) Individuals who have undergone surgery within 6 months prior to consent that may affect the study (e.g., colorectal endoscopic surgery, cholecystectomy for gallstones, gastric bypass). (5) Individuals with a history or current serious disease of the heart, liver, kidneys, or gastrointestinal tract. (6) Individuals who are pregnant, breastfeeding, or intend to become pregnant during the study period. (7) Individuals with a mushroom allergy or who cannot tolerate mushrooms. (8) Individuals judged by the principal investigator to be unsuitable for participation in this study. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 19 Day Date of IRB - 2025 Year 12 Month 19 Day Anticipated trial start date - 2026 Year 01 Month 30 Day Last follow-up date - 2026 Year 03 Month 14 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068971

Disclaimer: Curated by HT Syndication.