Tokyo, Oct. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059395) titled 'The Effects of Consumption of Test Foods on Women's Health Condition -A Placebo-Controlled Randomized Double-Blind Parallel-Group Comparative Trial-' on Oct. 14.

Study Type: Interventional

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

Primary Sponsor: Institute - Macromill Carenet, Inc.

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

Objective: Narrative objectives1 - Evaluating the effects of consuming test foods on health status Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Take two test food tablets per day Interventions/Control_2 - Take two placebo food tablets per day

Eligibility: Age-lower limit - 20 years-old = Gender - Female Key inclusion criteria - (1) Age from 20 to 45, at the time of obtaining consent to participate in the trial (2) Healthy Japanese women (3) Subjects with a normal menstrual cycle and a normal menstrual period (4) Subjects who experience physical discomfort associated with their menstrual cycle, have premenstrual symptoms, and are aware that they often strongly experience symptoms during menstruation (such as various types of menstrual pain, fatigue, and emotional instability). (5) Subjects who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, fully understand the information, voluntarily participate of their own free will, and whose consent is obtained through electronic informed consent. Key exclusion criteria - (1) Subjects with Gynecological disorders (PMS, PMDD, dysmenorrhea, menopausal disorders, hormone replacement therapy, uterine/ovarian/mammary gland disorders, etc.), psychiatric disorders (depression, anxiety disorders, insomnia, panic disorder, etc.), thyroid disorders (Graves' disease, Hashimoto's thyroiditis, etc.), autonomic nervous system disorders (autonomic imbalance, etc.), who are receiving treatment or medication from a physician, or who plan to receive treatment or medication during the trial period. (2) Subjects with skin conditions (such as atopic dermatitis, skin allergy symptoms, eczema, or hypersensitivity) who are currently receiving treatment or medication from a physician, or who plan to receive treatment or medication during the trial period. (3) Subjects with chronic conditions (such as anemia, perennial allergies, bronchial asthma, etc.) who are receiving treatment and medication from a physician. (4) Subjects with a history of serious cerebrovascular disease, heart disease, liver disease, kidney disease, blood disorders, or endocrine disorders. (5) Subjects with a history of serious digestive system diseases, such as gastrectomy, gastrointestinal anastomosis, or bowel resection (excluding those who have undergone appendectomy only). (6) Subjects whom the responsible physician determines to have a mental disorder based on SDS scores. (7) Subjects who have previously experienced discomfort or worsening health following blood draws. (8) Subjects at risk of developing allergies to test foods. (9) Subjects who donated 200 mL of whole blood within 4 weeks prior to the web screening test, or donated blood components within 2 weeks prior to the web screening test; or individuals who donated 400 mL of whole blood within 16 weeks prior to the web screening test. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 14 Day Date of IRB - 2025 Year 10 Month 14 Day Anticipated trial start date - 2025 Year 10 Month 15 Day Last follow-up date - 2026 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067927

Disclaimer: Curated by HT Syndication.