Healthy adults
Conditions
Interventions
Washout period for 21 days ->
Taking a test food at low dose for 14 days ->
Taking a test food at high dose for 14 days
Taking a test food at low dose for 14 days ->
Taking a test food at high dose for 14 days ->
Taking a control food for 14 days
Taking a test food at high dose for 14 days ->
Washout period for 21 days ->
Taking a control food for 14 days ->
Taking a test food at low dose for 14 days
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy males and females from 20 to 64 years old 2)Subjects with defecation at three to five times per week 3)Subjects with fewer number and lower ratio of Bifidobacterium in feces 4)Subjects who have received written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects who regularly use laxatives 2) Subjects who regularly take foods which may affect gastrointestinal condition 3) Subjects who regularly use antibiotics and other medicines which affect digestion and absorption 4) Subjects who cannot abstain from taking foods which are containing viable bacteria, enriched with oligosaccharides or dietary fiber, considered effective for constipation improvement and are containing large amount of sugar alcohol 5) Subjects who have allergy for foods 6) Subjects who regularly take too much alcohol 7) Subjects who have diseases which require urgent treatment or severe complications 8) Subjects who have gastrointestinal diseases or a surgical history which may affect digestion, absorption and defecation 9) Subjects who are pregnant, lactating or planning to be pregnant in the test period 10) Subjects who are under treatment or have a history of drug addiction or alcoholism 11) Subjects who are participating or planning to participate in a clinical study 12) Subjects who are judged as inappropriate by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and ratio of fecal Bifidobacterium Defecation frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| Defecation days, stool volume, stool shape, stool color, stool smell and the feeling after defecation Intestinal microflora analysis Fecal ammonia measurement Fecal pH measurement Fecal water content measurement Stool weight | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Sales department
Outcome results
None listed