None listed
Conditions
Interventions
4 weeks).
Oral intake of the placebo food (1 capsule in a day
4 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women between 20 and 64 years of age at the time of obtaining consent to participate in the study. 2) Individuals who are healthy and have no chronic physical disease including skin disease. 3) Individuals with relatively hard stools and suffering from mild constipation. 4) Individuals with spontaneous defecation frequency of 3-4 times per week. 5) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing. 6) Individuals who can come to the designated venue for this study and be inspected. 7) Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: Individuals 1) with chronic illnesses and individuals undergoing treatment for any illness. 2) with a history or current history of chronic fatigue syndrome, mental illness, sleep disorders, hypertension, diabetes, dyslipidemia or serious illness. 3) with a history of serious or current illness in the liver, kidney, heart, lungs, blood, or gastrointestinal tract. 4) with serious anemia. 5) with a habit of taking or applying drugs for the purpose of disease treatment in the past month. 6) who have been diagnosed and are being treated for functional constipation at a medical institution. 7) who are determined to have chronic constipation according to the diagnostic criteria of the Guidelines for the Diagnosis of Bowel Movement Disorders 2023. 8) whose BMI is over 30 kg/m2. 9) who may develop allergic symptoms to any ingredient in the tested food, or to any other food or drug. 10) who are currently, or have been within the past 3 months, habitual consumers of food for specified health uses, functional foods, health foods, supplements, etc., or who plan to consume such foods during the study period. 11) who have a habit of consuming yogurt, fermented foods rich in lactic acid bacteria, etc. at least 5 days per week. 12) whose daily alcohol consumption exceeds 40 g/day for men and 20 g/day for women on a weekly average of pure alcohol equivalent. 13) who are a smoker. 14) with irregular lifestyles, such as shift work, night work, etc. 15) with possible changes of life style during the test period. 16) who have had more than 200 mL of blood drawn within 1 month of the start of this study or more than 400 mL within 3 months of the start of this study. 17) who are currently participating in another human clinical trial or who have not yet completed 3 months of participation in another human clinical trial. 18) who are pregnant, lactating or can become pregnant and intend to become pregnant during the study period. 19) judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diary of bowel movements (Daily from before ingestion to the end of the study) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary Endpoints Diary of bowel movements (1) Intestinal microflora analysis (2) Fecal organic acid analysis (2) Blood special tests (2) Sleep related indicators (2) Stress related indicators (2) Fatigue related indicators (2) *Safety endpoints Physical examination (2) Clinical examination (2) Doctor's questions (2) Determination of adverse events and side effects (2) Subject's diary (1) (1):Daily from before ingestion to the end of the study (2):Week 0, Week 4 | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed