a tendency toward constipation (healthy adults)
Conditions
Interventions
Placebo beverage (for 4-week intake) ->
4-week washout ->
Test beverage, containing HBF2019-04 (for 4-week intake)
Test beverage, containing HBF2019-04 (for 4-week intake) ->
Placebo beverage (for 4-week intake)
Sponsors
Oneness Support Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Healthy males and females aged 20-69 years old when informed consent. [2] A tendency toward constipation (at 2-5 times of defecation per week). [3] Individuals giving written informed consent.
Exclusion criteria
Exclusion criteria: [1] Who have a disease and/or surgical history of serious hepatopathy, kidney damage, gastrointestinal disease, heart disease, peripheral vascular disorder, others which may affect the results of the study. [2] Who with liver disorder, and/or kidney disorder. [3] who are under medical treatments. [4] Who are allergic to foods and/or medicines. [5] Who are diagnosed as anemia. [6] Who play intense sports and/or on a diet. [7] Who use supplements which may affect the results of the study. [8] Who daily intake fermented foods such as yogurt and natto. [9] Who take medicines. [10] Who daily take excessive alcohol, and/or can't abstinent from alcohol from the day before the each examinations. [11] Who donated blood over 200 mL as a component blood or whole blood from 4 weeks before the start of this study. [12] Who are or are possibly pregnant, or who are lactating, during the study period. [13] Who are participating or are willing to participate in other studies. [14] Who are judged inappropriate for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| defecation frequency, defecation days, stool output, fecal condition (week 0-week 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| [Secondary outcomes] *Analysis of the intestinal flora microbiota (week 0, week 4) *Visual Analogue Scale (week 0, week 4) *Body fat percentage [Safety] Doctor's questions (week 0-week 4) | — |
Countries
Japan
Contacts
Public ContactYuki Ishida
Hayashibara CO., LTD. R & D Division, Development Unit
Outcome results
None listed