Adult
Conditions
Interventions
functional food Intake:15g/day Ingesion:28days
Placebo food Intake:15g/day Ingesion:28days (Screening phase: 7days)
Sponsors
Yamada Bee Company, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy Japanese men and women between 20 and 65 years of age at the time of consent 2) Have 3 to 5 bowel movements per week 3) Subjects who regularly consume 3 meals a day. 4) Subjects who have fully understood the content of the study and have given their voluntary consent to participate in the study. 5) Subjects who are able to understand and comply with the study's administrative requirements during the study period.
Exclusion criteria
Exclusion criteria: Those who consume honey on a daily basis. Those who are unable to refrain from consuming foods containing viable bacteria such as lactic acid bacteria and Bacillus subtilis natto, foods fortified with oligosaccharides and dietary fiber, health foods (including foods for specified health uses and foods with functional claims) that are said to be beneficial for improving constipation, and foods containing large amounts of sugar alcohols during the test period. Persons who are regularly using medicines (e.g., laxatives), health foods, or supplements that may affect the test results, and who are unable to discontinue their use from the time of obtaining consent. Persons who may show allergic symptoms to any of the ingredients in the test product. Persons who have changed or plan to change their diet during the study period. Persons who suffer from serious hepatic disorder, renal or cardiac disease, organ disorder, diabetes mellitus, or other serious diseases. Those who have a history of major surgery on the gastrointestinal tract, such as gastrectomy, gastrointestinal suturing, or intestinal resection. Those who consume excessive amounts of alcohol (more than 40 g/day in terms of pure alcohol content). Those unable to maintain a regular lifestyle. Pregnant or intending to become pregnant, or breast-feeding. Those who are participating in other clinical trials or clinical studies during the study period. Other subjects who are judged by the investigator to be inappropriate for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of bowel movements per week | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Questionnaire for Constipation (PAC-QOL) Defecation Diary -Number of days with bowel movements -Stool volume -Stool shape -Stool color -Smell of stool -Breathing strength during defecation -Sensation of residual feces -Abdominal symptoms (pain or discomfort in the abdomen (excluding menstrual cramps)) | — |
Countries
Japan
Contacts
Public ContactAkio Ohkuma
Research Center for Immunological Analysis, Inc. -
Outcome results
None listed