Healthy adults
Conditions
Interventions
Consumption of the test food (1 pack a day, 8weeks)
Consumption of the placebo food (1 pack a day, 8 weeks)
Sponsors
Morishita Jintan Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Premenopausal women aged 20-64 years 2) Subjects with constipation tendencies having mainly 3-5 bowel movements per week at the time of screening 3) Subjects who have a regular diet (three meals a day (breakfast, lunch, and dinner )) 4) Subjects who are concerned about drying of the skin as subjective symptoms 5) Subjects who use only one or two items of skin care products, such as lotion and emulsion, after daily face washing 6) Subjects who have received a sufficient explanation regarding the purpose and details of this study, are capable of providing informed consent, fully understand the information provided, and voluntarily agree in writing to participate in this study
Exclusion criteria
Exclusion criteria: 1) Subjects who meet the diagnostic criteria for chronic constipation in the clinical guidelines for chronic constipation 2023 2) Subjects who regularly consume large amounts of foods containing active ingredient, or health foods containing active ingredient 3) Subjects who regularly take medications, including intestinal regulators, laxatives, and purgatives (regulators are permissible if discontinued from screening to study end) 4) Subjects with severe liver, kidney, digestive, heart, respiratory, endocrine, thyroid, adrenal diseases, or other metabolic disorders (excluding transient conditions such as the common cold) 5) Subjects who have a digestive disease that affects digestion and absorption, or a history of surgery (excluding appendicitis) 6) Subjects who have a history or current medical history of drug dependence or alcoholism 7) Subjects who are diagnosed with chronic constipation 8) Subjects who are unable to stop taking health foods or supplements (including FOSHU/FFC) that may affect this study 9) Subjects who have a habit of drinking excessively (>= 20g pure alcohol eq./day, >= 4 days/week) 10) Subjects who have a habit of smoking excessively (>= 21 cigarettes/day) 11) Shift worker or night-shift worker (excluding daytime shift work) 12) Subjects who plan to travel overseas or domestic long-term for personal or business purposes (> 10 days/month), or be transferred during this study 13) Subjects who have donated > 200 mL blood/component blood within one month or > 400 mL within three months prior to screening test 14) Subjects who consume yogurt, lactic acid bacteria, or bifidobacteria-containing foods >= 3 times/week, or unwillingness to refrain during the study 15) Subjects who have any factors on the skin of the evaluation site that may affect the test results (such as diseases like urticaria, inflammation, eczema, trauma, acne, pimples, warts, spots, or their traces)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transepidermal water loss at 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Stratum corneum water 2) Skin elasticity 3) Stratum corneum analysis 4) Puerefactive products in feces 5) blood phenol 6) blood malondialdehyde 7) concentrations of salivary cortisol 8) Image analysis by VISIA 9) Visual Analogue Scale | — |
Countries
Japan
Contacts
Public ContactAkifumi NAGATOMO
Morishita Jintan Co., Ltd. Research and Development Headquarters, Fundamental Research and Development Department
Outcome results
None listed