None listed
Conditions
Interventions
Oral intake of the test product (1 pack a day
8 weeks).
Oral intake of the placebo product (1 pack a day
8 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Males and females aged 35-59 years. [2] Individuals who are healthy and have no chronic physical disease including skin disease. [3] Individuals with a tendency for constipation (at 3-4 times of defecation per week); whose stool shape is relatively hard and who have unpleasant sensation on defecation. [4]Individuals who are aware of skin dryness. [5] Individuals whose written informed consent has been obtained after explanation of this study. [6] Individuals who can have an examination on a designated check day [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 have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [4] Individuals who are a patient or have a history of or endocrine disease. [5] Individuals whose stool frequency is less than 3 times per week. [6] Individuals who are constipated because of intaking internal medicine. [7] Individuals who have idiopathic constipation. [8] Individuals whose eating habits are irregular. [9] Individuals with strange skin conditions at measurement points. [10] Individuals with strange skin conditions at measurement points. [11] Individuals who used a drug to treat a disease in the past 1 month. [12] Individuals with serious anemia. [13] Individuals whose BMI is over 30 kg/m2. [14] Individuals who are sensitive to test product or other foods, and medical products. [15] Individuals who have a habit to ingest special health food, food with functional claims, health-promoting foods, or supplements claiming to improve skin condition and stool in the past 3 months or will ingest those foods during the test period. [16] Individuals who are or are possibly pregnant, or are lactating. [17] Individuals who excessively take alcohol. [18]Individuals who are a smoker. [19] Individuals with possible changes of life style during the test period. [20] Individuals who will develop seasonal allergy symptoms like hay fever and be to suffer from worsening eyes and nose symptoms or use anti-allergic drugs during the test period. [21]individuals who neglect skin care. [22]Individuals who will get sunburned during the test period. [23]Individuals who had been conducted an operation or beauty treatment on the test spot. [24]Individuals who participated in other clinical studies in the past 3 months. [25]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bowel diary (stool frequency and number of defecation days : Everyday From the seven days before the first day of ingestion of a test material to the last day of the test.) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary indexes [1] Indexes for evaluating defecation (1)Bowel diary (Volume of defecation, fecal odor, feeling of incomplete defecation: Everyday From the seven days before the first day of ingestion of a test material to the last day of the test.) (2)The Japanese Version of the Constipation Assessment Scale [middle term] (Week 0, home survey, Week 8) (3)Bristol stool scale. (Week 0, home survey, Week 8) (4)Analysis of intestinal flora (Week 0, Week 8) [2] Index for Skin quality evaluation. (Week 0, Week 8) [3] Questionnaire of physical feeling. (Week 0, home survey, Week 8) [4] brief-type self-administered diet history questionnaire. (Week 0, home survey, Week 8) *Safety [1] Blood pressure, pulsation. (Week 0, Week 8) [2] Weight,body fat percentage,BMI. (Week 0, Week 8) [3] Hematologic test. (Week 0, Week 8) [4] Blood biochemical test. (Week 0, Week 8) [5] Urine analysis. (Week 0, Week 8) [6] Doctor's questions. (Week 0, Week 8) [7] Side effects/ Adverse events. (Week 0, Week 8) [8] Subject's diary. (Everyday From the seven days before the first day of ingestion of a test material to the last day of the test.) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed