Tokyo, Sept. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062719) titled 'A Study on the Efficacy of test food in Volunteers with Tinnitus-Like Symptoms' on Sept. 4.

Study Type: Interventional

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

Primary Sponsor: Institute - Leverage Brain Inc.

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

Objective: Narrative objectives1 - To evaluate the efficacy of continuous consumption of the test food for 12 weeks on tinnitus-like symptoms. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Ingest the test food for 12 weeks Interventions/Control_2 - Ingest the placebo food for 12 weeks

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1) Subjects recognized as healthy by a doctor's diagnosis 2) Japanese males and females aged 18 to 75 years-old at the time of informed consent 3) Subjects who experience tinnitus and have a THI (Tinnitus Handicap Inventory) score of 18 to 56 4) Subjects who have received a thorough explanation of the protocol, have understood its content, and have provided written consent to participate in this trial Key exclusion criteria - 1) Subjects who have a history of severe ear disorders such as Sudden Sensorineural Hearing Loss (SSHL), acoustic neuroma, Meniere's disease, etc. 2) Subjects who wear hearing aids . 3) Subjects with mental disorders (depressive disorders, bipolar disorder, schizophrenia, panic disorder, obsessive-compulsive disorder, etc.) 4) Subject who are unable to stop consuming foods and beverages with specific health claims, foods with functional claims, or other foods and beverages believed to have functional properties during the study period. 5) Subjects receiving treatment, medication, and lifestyle guidance from a doctor due to tinnitus or ear disease 6) Subject who has serious disorders on brain, hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system, and metabolic system 7) Subjects who have diseases requiring continuous medication, or serious medical history who needed medication 8) Subjects who have a history of a serious disease that required medication 9) Subjects currently receiving medical treatment for a gastrointestinal disorder, or those with a history of gastrointestinal surgery (excluding appendectomy performed more than 30 days prior to obtaining consent) 10) Subjects with history of sensitivity to the ingredients of test food 11) Pregnant, lactating women or willing to be pregnancy during the clinical trial 12) Subjects who are judged to be unsuitable based on their responses to the background survey 13) Subject who took part in the other clinical/monitoring trial within 30 days before giving informed consent to take part in this trial. 14) Subjects who have been deemed unsuitable as clinical trial participants by the principal investigator or sub-investigator Target Size - 184

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 31 Day Date of IRB - 2026 Year 08 Month 27 Day Anticipated trial start date - 2026 Year 09 Month 04 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=R000071780

Disclaimer: Curated by HT Syndication.