N/A(healthy adults)
Conditions
Interventions
[1]Oral ingestion of the test food (2 tablets once a day for 4 weeks) [2]Washout (4 week) [3]Oral ingestion of the placebo food (2 tablets once a day for 4 weeks)
[1]Oral ingestion of the Placebo f
Sponsors
TES Holdings Co., Ltd
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: [1]Japanese females aged 40-60 years. [2]Individuals who are healthy and are not suffered from a chronic malady. [3]Individuals with a tendency for constipation (at 3-4 times of defecation per week). [4]Individuals whose written informed consent has been obtained. [5]Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1]Individuals who have a habit of intaking a food containing lactic acid bacteria powder over 4 times per week. [2]Individuals using medical products. [3]Individuals who have a habit of using or applying a drug. [4]Individuals who intake laxatives, antiflatulent, or supplements aiming to improve bowel movements (ex. indigestible dextrin, oligosaccharide, dietary fiber-rich foods). [5]Individuals whose dietary pattern is unstable. [6]Individuals who take medicine in the past 1 month to remedy disease (except of temporal taking medicine for headache or cold). [7]Individuals who intook antibiotics in the past 1 month. [8]Individuals who have a history of heart failure, kidney failure, hepatitis B or hepatitis C. [9]Individuals who are a patient or have a history of or endocrine disease. [10]Individuals whose BMI is over 25 kg/m2. [11]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [12]Individuals who are a smoker. [13]Individuals with serious anemia. [14]Individuals who are sensitive to test product or other foods, and medical products. [15]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. [16]Individuals whose life style will be changed during the test period. [17]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [18]Individuals who cannot collect fecal samples in their own house and submit them to the designated organization. [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 |
|---|---|
| [1]Indexes for evaluating defecation and intestinal flora (The Japanese Version of the Constipation Assessment Scale [middle term] [first observation: Week 0, 2, 4; second observation: Week 0, 2, 4], Bristol stool scale [first observation: Week 0, 2, 4; second observation: Week 0, 2, 4], fecal examination [analysis of intestinal flora, short-chain fatty acid, pH, putrefaction products, IgA] [[first observation: Week 0, 2, 4; second observation: Week 0, 2, 4]) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcome [1]Bowel diary (from the first day of ingestion of a test material to the last day of the test) *Safety evaluation [1]Blood pressure, pulsation (Screening, First observation: Week 4, Second observation: Week 4) [2]Weight, body fat percentage, BMI (Screening, First observation: Week 4, Second observation: Week 4) [3]Doctor's questions (Screening, First observation: Week 4, Second observation: Week 4) [4]Subject's diary(from 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