Tokyo, Aug. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062480) titled 'Study on the Effects of Continuous Intake of Foods Containing Fermented Panax ginseng Extract on Gut Microbiota and Health' on Aug. 5.

Study Type: Interventional

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

Primary Sponsor: Institute - to clinic shibuya

Condition: Condition - Healthy adult men Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effect of a food containing fermented red ginseng extract on the gut microbiota in healthy adult men, compared to a placebo food. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Fermented red ginseng extract-containing food group: Oral intake of fermented red ginseng extract-containing food (10 g/packet), 2 packets/day for 8 weeks. Interventions/Control_2 - Placebo group: Oral intake of placebo food (without fermented red ginseng extract, 10 g/packet), 2 packets/day for 8 weeks.

Eligibility: Age-lower limit - 35 years-old = Gender - Male Key inclusion criteria - 1. Men aged 35 to 59 years, with no current disease under treatment and in good health. 2. Those who have provided written informed consent to participate in this study. 3. Those who can continuously visit the clinic during the study period. Key exclusion criteria - 1. Those with severe systemic diseases (heart disease, liver disease, kidney disease, inflammatory bowel disease, diabetes, etc.). 2. Those with a history of or currently undergoing treatment for malignant tumors. 3. Those with a history of or currently undergoing treatment for autoimmune diseases. 4. Those using immunosuppressants or steroid drugs. 5. Those who have taken medications affecting the gut microbiota (antibiotics, proton pump inhibitors (PPIs), potassium-competitive acid blockers (PCABs), and probiotics) within the past month. 6. Those who have consumed drugs or foods containing ginseng within the past month. 7. Those with a known history of allergy to ginseng. 8. Those who dislike the flavor of foods containing ginseng and cannot consume them continuously. 9. Those who have difficulty making decisions about study participation due to mental illness. 10. Others deemed inappropriate by the principal investigator. Target Size - 100

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2026 Year 03 Month 19 Day Date of IRB - 2026 Year 03 Month 19 Day Anticipated trial start date - 2026 Year 05 Month 22 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071510

Disclaimer: Curated by HT Syndication.