Subjects who have a tendency to be constipated
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Subjects from 20 to 69 years-old 2)Subjects with constipation tendency (their defecation frequency is 2 to 4 times a week in the past about 3 months,and constipation is not so severe) 3)Subjects undergoing none of medical treatments 4)Subjects who can record daily logs during the designated period 5)Subjects who can record diet records on specified days 6)Subjects who can visit during the designated period 7)Subjects who can collect and submit a sample during the designated period
Exclusion criteria
Exclusion criteria: 1)Subjects with serious liver disease,renal/heart disease,organ disorder,diabetes,food allergy,gastrointestinal disease,other serious diseases 2)Subjects have a medical history or a surgical history of digestive diseases 3)Subjects allergic to a specific drug or food 4)Subjects allergic to samples in this study 5)Subjects with a large influence on defecation during menstruation or in poor physical condition 6)Pregnants,lactating women or who is going to be pregnant during study 7)Subjects drawn blood over 200mL last 1 month,or over 400mL last3 months before consent acquisition date 8)Subjects scheduled for medical examination during study 9)Subjects who can't maintain everyday life habits 10)Subjects who do not ingest three meals a day 11)Subjects who do not ingest beverages at breakfast 12)Subjects working at night or in rotation 13)Subjects with a several variation of the amount of diet or movement 14)Subjects drink alcohol over 500mL in terms of beer per day 15)Subjects smoke over average 20 cigarettes per day 16)Subjects who have any kinds of drugs affect this study (constipation drugs,intestinal drugs,antibiotics,etc.) 17)Subjects who can not refrain from using health foods,during the study 18)Subjects never be able to stop intaking foods or drinks which improve constipation during study,such as foods containing lactic acid bacteria,bifidobacteria,natto bacteria,oligosaccharides,dietary fibers and/or other health foods including food for specified health use 19)Subjects who can not take the test food as instructed 20)Subjects who have participated in the other clinical studies 21)Subjects judged as unsuitable for the study by the principal investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency, fecal amount | — |
Secondary
| Measure | Time frame |
|---|---|
| Fecal shape,Fecal color,Feelings after defecation,Intestinal flora(Real-Time PCR),Fecal ammonia content,Fecal pH,Fecal moisture content | — |
Countries
Japan
Contacts
APO PLUS STATION CO., LTD. CRO Department Food Test Division