None listed
Conditions
Interventions
Oral intake of the test food 5 capsules 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 65 years of age at the time of obtaining consent to participate in the study. 2) Individuals who have relatively hard stools and suffer from mild constipation. 3) Individuals with spontaneous defecation frequency of 3-4 times per week. 4) Individuals who are healthy and have no chronic physical disease including skin disease. 5) Individuals whose written informed consent has been obtained. 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: 1) Individuals using medical products. 2) Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. 3) Individuals who used a drug to treat a disease in the past 1 month. 4) Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. 5) Individuals who are a patient or have a history of or endocrine disease. 6) Individuals who have been diagnosed and are under treatment for functional constipation at a medical institution. 7) Individuals who are determined to have chronic constipation in the diagnostic criteria for chronic constipation. 8) Individuals whose BMI is less than 18.5kg/m2 and over 30kg/m2. 9) Individuals with systolic blood pressure 140 mmHg or higher, diastolic blood pressure 90 mmHg or higher, pulse 85 beats/min or higher. 10) Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. 11) Individuals who experienced unpleasant feeling during blood drawing. 12) Individuals with drug and food allergies. 13) Individuals who have been regularly using food for specified health use, functional foods, or health foods in the past 3 months or at present. 14) Individuals who have a habit of consuming yogurt and fermented foods rich in lactic acid bacteria. 15) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day). 16) Individuals with possible changes of life style during the test period. 17) Individuals who are pregnant, breastfeeding, or who may become pregnant during the study period. 18) Individuals who participated in other clinical studies in the past 3 months. 19) Individuals who are or whose family is engaged in healthy or functional foods. 20) Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Existence and its contents of side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed). (Week 0, Week 2, Week 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes 1) Physical xamination (Week 0, Week 2, Week 4). 2) Biochemical examination (Week 0, Week 2, Week 4). 3) Doctor's questions (Week 0, Week 2, Week 4). 4) Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) (Week 0, Week 2, Week 4). * Efficacy Exploratory Index 1) Blood and fecal special tests (Week 0, Week 4). | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed