Tokyo, July 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058604) titled 'Placebo-controlled randomized double-blind crossover trial on the effect of continuous intake of lactic acid bacteria on improving weather-related illness symptoms' on July 24.

Study Type: Interventional

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

Primary Sponsor: Institute - Macromill, Inc.

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

Objective: Narrative objectives1 - A placebo-controlled, randomized, double-blind crossover trial will be conducted on women with weather-related illness to examine the effects of continuous consumption of the test food for four weeks on improving weather-related illness. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Consume the test food for four weeks, then consume the placebo food for four weeks after a washout period. Interventions/Control_2 - Consumption of placebo food for four weeks, followed by consumption of test food for four weeks after washout period.

Eligibility: Age-lower limit - 20 years-old

Gender - Female Key inclusion criteria - (1) Healthy adult women aged 20 to 49 at the time of obtaining consent to participate in the trial (2) Individuals who are aware of changes in their physical condition due to weather conditions (3) Individuals who have received sufficient explanation of the purpose and content of this trial, have the capacity to consent, have fully understood the trial, have volunteered of their own free will, and have given their consent through electronic informed consent Key exclusion criteria - (1) Under treatment or planning treatment for gynecological conditions (e.g., dysmenorrhea, PMS, PMDD, menopausal symptoms, uterine/ovarian/breast disorders). (2) Under treatment or planning treatment for mental (e.g., depression, anxiety, insomnia), thyroid (e.g., Graves's, Hashimoto's), autonomic, migraine, or ENT disorders (e.g., vertigo, tinnitus, hearing loss). (3) Having chronic diseases requiring regular treatment. (4) History of major gastrointestinal surgery (e.g., gastrectomy, bowel resection), or under treatment for serious gastrointestinal conditions (excluding appendectomy only). (5) Pregnant, breastfeeding, possibly pregnant, or planning pregnancy during the study. (6) Allergy to study product. (7) Regular use of health/functional foods or supplements that cannot be discontinued. (8) Heavy smokers (>=21 cigarettes/day). (9) High alcohol consumers (>=60 g/day, >=6 days/week; e.g., 3 servings of sake, 1500 mL beer, 2 shochu, or 5 glasses of wine). (10) Irregular lifestyle (e.g., night/shift workers). (11) Anticipated major lifestyle changes (e.g., relocation, long trip) or changes in diet/exercise. (12) Participation in other trials within 4 weeks or during the study period. (13) Judged ineligible by the investigator. Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 22 Day Anticipated trial start date - 2025 Year 07 Month 25 Day Last follow-up date - 2025 Year 12 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067009

Disclaimer: Curated by HT Syndication.