Healthy subjects
Conditions
Interventions
Continuous ingestion of the test food 1 for 4 weeks
Continuous ingestion of the test food 2 for 4 weeks
Continuous ingestion of the placebo food for 4 weeks
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Healthy Japanese males and females who are aged 20 to under 70 years at the time of written informed consent. 2.Subjects who defecate three to five times per week at screening period. 3.Subjects whose BMI is less than 30 kg/m2. 4.Subjects who have regular eating habits every day and are able to generally eat three meals a day during the study. 5.Subjects who have been fully informed the purpose and details of the study, have the 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 diagnosed with constipated by a physician or have diseases that may substantially affect bowel movement. 2.Subjects with current or previous history of a brain disease, malignancy, immunological disease, diabetes mellitus, hepatic disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, metabolic disease, or other serious diseases. 3.Subjects receiving medication or outpatient treatment for a serious disease. 4.Subjects receiving exercise or diet therapy under the supervision of a physician. 5.Subjects with current or previous history of drug dependence or alcohol dependence. 6.Subjects who are currently seeing a doctor for the treatment of a psychiatric disorder (e.g., depression) and/or sleep disorder (e.g., insomnia, sleep apnea syndrome) or have previous history of a psychiatric disorder. 7.Subjects who are taking antibiotics or other medications that affect the gut microbiome or who plan to take these during the study. 8.Subjects who regularly use bowel-regulating drugs (including traditional Chinese medicines), quasi-drugs (e.g., probiotics, constipation medicines including laxatives), health foods, or supplements or who cannot avoid using them. 9.Subjects who were consuming health oils (e.g., coconut oil, MCT oil) that may increase the effects of the food components to be evaluated 4 days or more each week during the past three months or who are consuming such oils. 10.Subjects who are consuming foods rich in components that may affect bowel movements, or foods rich in components that may affect the research area (e.g., yogurt, lactic acid bacteria beverages, fiber- or oligosaccharide-enriched foods, milk, butter, ice cream, cheese, foods rich in milk fat, other fermented foods, granola, prunes) 4 days or more each week. 11.Subjects who are at risk of developing allergic reactions due to the ingredients of the test food's or other factors. 12.Night or shift workers with irregular life patterns.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency and number of days with defecation | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Gut microbiota, Bowel habits(stool volume, stool consistency,stool color, stool odor, stool smell, and post-defecation sensation), VAS assessment of abdominal symptoms, POMS 2-A short, fecal short-chain fatty acid (SCFA) concentrations, fecal bile acid concentrations, fecal metabolites, in vitro fecal culture assay using stool samples,association analysis between evaluation parameters and single nucleotide polymorphisms (SNPs) (Safety evaluation) Vital signs, physical measurements (body weight and BMI), blood biochemical examination, hematologic test, adverse events | — |
Countries
Japan
Contacts
Public ContactHiroyuki Miyazawa
HUMA R&D CORP Clinical Development Department
Outcome results
None listed