Clinical Trial: Effects of Continuous Intake of the Test Food on Improvement of Bowel Movements in Individuals with a Tendency to Constipation (Japan)

Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059228) titled 'Effects of Continuous Intake of the Test Food on Improvement of Bowel Movements in Individuals with a Tendency to Constipation' on April 1.

Study Type: Interventional

Study Design: Basic Design - Parallel 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 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study on the Effects of Four-Week Continuous Intake of the Test Food on Gastrointestinal and Related Symptoms in Healthy Individuals with Constipation Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - 4-week intake of test food-1 Interventions/Control_2 - 4-week intake of test food-2

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - (1) Male and female participants aged 20 years or older and younger than 65 years at the time of informed consent. (2) Individuals whose bowel movement frequency is between 3 and 5 times per week (3) Individuals who have received sufficient explanation regarding the purpose and content of the study, have the capacity to consent, fully understand the information provided, voluntarily agree to participate, and provide their own consent via electronic informed consent (eConsent). Key exclusion criteria - (1) Individuals using bowel-regulating drugs, such as laxatives or antidiarrheals, including over-the-counter products. (2) Those under treatment for chronic diseases such as diabetes, dyslipidemia, or hypertension. (3) Those with malignant tumors; cerebrovascular, cardiac, hepatic, renal, hematologic, or endocrine disease; gastric or duodenal ulcer under treatment; or a severe medical history. (4) History of major gastrointestinal surgery, including gastrectomy, anastomosis, or intestinal resection, except for appendectomy only. (5) Dermatological conditions such as atopic dermatitis, allergy, eczema, or hypersensitivity under treatment. (6) Cosmetic procedures at the evaluation site within the past 12 weeks, such as collagen, hyaluronic acid, botulinum toxin, or laser, or those unable to refrain during the study. (7) Excessive tanning or inability to avoid intentional sun exposure. (8) Allergy to the test food. (9) Habitual use of health foods, foods with functional claims, probiotics such as yogurt or lactic drinks, or supplements, and unable to stop during the study. (10) Heavy smokers, defined as more than 20 cigarettes per day. (11) Regular alcohol consumers, defined as 60 grams or more of pure alcohol per day, approximately sake three servings, beer 1,500 mL, shochu two servings, or wine 600 mL, on six or more days per week. (12) Extremely irregular sleep or diet, such as shift or night workers. (13) Likely to experience major lifestyle, diet, or exercise changes during the study. (14) Women who are lactating, pregnant, possibly pregnant, or planning pregnancy. (15) Currently in another clinical trial, within the past four weeks, or planning to join during this study. (16) Deemed ineligible by the principal investigator or sub-investigator. (17) Deemed unsuitable by the sponsor. Target Size - 180

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 29 Day Date of IRB - 2025 Year 09 Month 29 Day Anticipated trial start date - 2025 Year 09 Month 30 Day Last follow-up date - 2026 Year 03 Month 08 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067738

Disclaimer: Curated by HT Syndication.