N/A(healthy adults)
Conditions
Interventions
Oral intake of the test product (4 capsules in a day for 4 weeks)
Oral intake of the placebo product (4 capsules in a day for 4 weeks)
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Healthy Japanese males and females aged 20-59 years. [2]Individuals who are healthy and have no chronic physical disease. [3]Individuals with a tendency for constipation (at 3-5 times of defecation per week); whose stool shape is relatively hard and who have unpleasant sensation on defecation. [4]Individuals whose written informed consent has been obtained. [5]Individuals who can have an examination on a designated check day. [6]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 whose stool frequency is less than 3 times per week. [4]Individuals who are constipated because of intaking internal medicine. [5]Individuals who have idiopathic constipation. [6]Individuals whose eating habits are irregular. [7]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [8]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [9]Individuals who are a patient or have a history of or endocrine disease. [10]Individuals whose BMI is over 30. [11]Individuals who are sensitive to a test product or other foods, and medical products. [12]Individuals who intake laxatives, antiflatulent etc. aiming to improve bowel movements. [13]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [14]Individuals with possible changes of life style, such as working a night shift, during the test period. [15]Individuals who are or are possibly, or are lactating. [16]Individuals who participated in other clinical studies in the past 3 months. [17]Individuals who are or whose family is engaged in functional foods or cosmetics. [18]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Indexes for evaluating defecation (The Japanese Version of the Constipation Assessment Scale (1), Patient Assessment of Constipation of Quality Of Life scale (1), Bristol stool scale (1), bowel diary (2)). (1):Screening, Week 0, Week 2, Week 4. (2):From the first day of ingestion of a test material to the last day of the test. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Safety [1]Blood pressure, pulsation (Screening, Week 0, Week 4). [2]Weight, body fat percentage, BMI (Screening, Week 0, Week 4). [3]Doctor's questions (Screening, Week 0, Week 4). [4]Subject's diary (each day during the test period). | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed