Tokyo, Feb. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060632) titled 'Effects of mouthwash on oral nitrate metabolism and physical fitness' on Feb. 10.

Study Type: Interventional

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

Primary Sponsor: Institute - Waseda University

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

Objective: Narrative objectives1 - The purpose of the present study is to evaluate the effects of mouthwash use on salivary flora, salivary nitrate metabolites, blood nitrate metabolites, and exercise performance in healthy young men. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - By using active mouthwash for 28 days (3 times/day), exercise testing conducts on the first and final days. Washout more than 4 weeks. By using placebo mouthwash for 28 days (3 times/day), exercise testing conducts on the first and final days. Interventions/Control_2 - By using placebo mouthwash for 28 days (3 times/day), exercise testing conducts on the first and final days. Washout more than 4 weeks. By using active mouthwash for 28 days (3 times/day), exercise testing conducts on the first and final days.

Eligibility: Age-lower limit - 18 years-old

Gender - Male Key inclusion criteria - 1. Participants who are aged 60-79 years old 2. Male participants. 3. Participants who have no chronic disorders. 4. Participants who have no use of prescribed medication and supplements 5. Participants who are non-smokers. 6. Participants who have not gained or reduced weight in the past 3 months or who will not intend to lose weight within the examination period. 7. Not participating in other studies while they are participating in the present study. 8. Participants who have exercise habits (at least 30 min per session for 2 times a week). 9. Participants who are not allergic to commercially available mouthwashes or toothpastes Key exclusion criteria - 1. Participants who are not aged 60-79 years old 2. Female participants. 3. Participants who have chronic disorders. 4. Participants who have use of prescribed medication and supplements 5. Participants who are smokers. 6. Participants who have gained or reduced weight in the past 3 months or who will intend to lose weight within the examination period. 7. Participating in other studies while they are participating in the present study. 8. Participants who have no exercise habits (at least 30 min per session for 2 times a week). 9. Participants who are nallergic to commercially available mouthwashes or toothpastes Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 30 Day Anticipated trial start date - 2026 Year 02 Month 13 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069350

Disclaimer: Curated by HT Syndication.