Healthy subjects
Conditions
Interventions
Sponsors
Macromill, Inc.
PreMedica Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 with a bowel movement frequency of 7 times or more per week and soft stool consistency (Bristol Stool Form Scale type 4 to less than 7). (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).
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Bowel Movement Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Skin, Allergic Symptoms, and Fatigue Questionnaire (VAS) (2) Stress Questionnaire (POMS-2 Adult Short Form) (3) Gut Microbiota Analysis (4) Short-Chain Fatty Acids (5) Fecal Metabolites, etc. (6) Skin Viscoelasticity (7) Trans Epidermal Water Loss (8) Daily Log (Frequency/Severity of Health Concerns/Problems) | — |
Countries
Japan
Contacts
Public ContactYuki Mori
Macromill, Inc. Clinical Trial Department, Life Science Division
Outcome results
None listed