None listed
Conditions
Interventions
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 spontaneous bowel movements 2-4 times per week. 4) 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. 5) Individuals who can come to the designated venue for this study and be inspected. 6) 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 (Chronic Constipation). 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) whose daily alcohol consumption exceeds 40 g/day for men and 20 g/day for women on a weekly average of pure alcohol equivalent. 12) with irregular lifestyles, such as shift work, night work, etc. 13) with possible changes of life style during the test period. 14) who have had more than 200 mL of blood drawn (e.g., blood donation) within 1 month of the start of this study or more than 400 mL within 3 months of the start of this study. 15) who are currently participating in another human clinical trial or who have not yet completed 3 months of participation in another human clinical trial. 16) who are pregnant, lactating or can become pregnant and intend to become pregnant during the study period. 17) judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Efficacy endpoints 1) Bowel Movement Diary (1) 2) Intestinal Environment Related Indicators(2) *Eating Tendency Survey 1)Dietary survey with Brief-type Self-Administered Diet History Questionnaire (BDHQ)(2) *Safety endpoints 1) Physical examination (3) 2) Clinical examination (3) 3) Physician interview (3) 4) Occurrence of adverse events/side effects (4) 5) Subject diary(1) (1):Daily from the start of intake of the test food until the end of intake (2):Week 0, Week 4 (3):Week 0, Week 2, Week 4 (4):Week 2, Week 4 | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed