Healthy adult
Conditions
Interventions
Ingestion of test beverage (8 weeks)
Ingestion of control beverage (8 weeks)
Sponsors
Leverage Brain Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese male and female ages 20-65 years old (inclusive) 2) Subjects with tendency for constipation at 3 to 5 times of defecation per week 3) Subjects who competent to consent and give voluntary consent in writing with full understanding after receiving explanation of this study aim and contents
Exclusion criteria
Exclusion criteria: 1) Subjects with severe hepatic, renal, cardiac, pulmonary, gastrointestinal, hematologic, endocrine and metabolic diseases / disorders 2) Subjects who suffer from diseases/ disorders with continuous medical treatment or with medical history of severe diseases/ disorders needed medical treatment 3) Subjects who suffer from diseases/ disorders that affects the study and are receiving medical treatment from medical institution or have surgical history of digestive system (except appendectomy) 4) Subjects who suffer from diseases/ disorders that affects bowel movement such as irritable bowel syndrome or ulcerative colitis etc. or have medical history of above-mentioned diseases/ disorders 5) Subjects with history of sensitivity to the ingredients 6) Pregnant, lactating women or willing to be pregnancy during the study 7) Subjects who take any kind of medicine (laxative, intestinal drug etc.) that possibly affect bowel movement 8) Subjects who take supplements and/or functional foods (including Food for Specified Health Uses [FOSHU]) regularly that possibly affect bowel movement 9) Subjects who have a habit of eating lactic fermenting beverage or food or Lactobacillus preparation that contain many lactobacilli, food fortified with dietary fiber and/or oligosaccharide 3 and more times per week 10) Any candidate considered to be unsuitable for enrollment based on his/her answers of lifestyle questionnaire 11) Subjects who had participated in other clinical trials including drug and food within 1 month. 12) Subjects who are judged as inappropriate by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal flora analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Defecation frequency Defecation days Questionnaire on sleeping quality (OSA inventory-MA version) | — |
Countries
Japan
Contacts
Public ContactShigeru Imai
Leverage Brain Inc. Clinical Trial Department
Outcome results
None listed