Healthy subjects
Conditions
Interventions
Test food A intake for 4 weeks-Washout period for 4 weeks-Test food B intake for 4 weeks
Test food B intake for 4 weeks-Washout period for 4 weeks-Test food A intake for 4 weeks
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese males and females who are aged 20 years or over and less than 65 years at the time of written informed consent. 2.Subjects who defecate 5 or less than 5 times a week. 3.Subjects who are fully explained the purpose and details of the study, have ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study in writing.
Exclusion criteria
Exclusion criteria: 1.Subjects who routinely use drugs and quasi-drugs that improve intestinal health (e.g., intestinal drugs, constipation remedies [including laxatives]). 2.Subjects who are receiving drugs that affect the intestinal microbiota such as antibiotics. 3.Subjects with serious medical conditions such as diabetes, renal/hepatic impairment and heart disease, thyroid or adrenal gland disease, or other metabolic problems and those who are receiving medical treatment. 4.Subjects who are unable to refrain from eating food products that are known to help relieve constipation (e.g., yogurt, oligosaccharides) during the study period. 5.Subjects who habitually drink more alcohol than the recommended upper limit (i.e., mean daily alcohol consumption of about 40 g of pure alcohol equivalent; for example, two middle-size bottles [1000 mL] of beer). 6.Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating. 7.Subjects at risk for allergic reactions to the material of the test food (milk protein). 8.Subjects receiving exercise or diet therapy under the supervision of physicians. 9.Subjects with current or previous history of drug dependence or alcohol dependence. 10.Subject who is attending a hospital due to mental disorders (depression, etc.) or sleep disorders, or who has a history of mental illness in the past. 11.Night or shift workers with extremely irregular life patterns. 12.Subjects whose eating, sleeping, and other habits are extremely irregular. 13.Subjects who participated in another clinical study/research within 3 months before the date of informed consent or who plan to participate in another clinical study/research during the study period. 14.Subjects who donated more than 200 mL of whole blood, plasma, or platelets within 1 month before the date of informed consent or 400 mL within 3 months before the date of informed consent. 15.Subjects who have difficulty complying with recording of each survey form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation related survey integrated score (DRSIS) | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Stool tests (e.g., stool pH, concentrations of metabolites, gut microbiota) (Safety evaluation) Adverse events | — |
Countries
Japan
Contacts
Public ContactHidemasa Toya
HUMA R&D CORP Clinical Development Department
Outcome results
None listed