None listed
Conditions
Interventions
Food containing plant constituents, feeding three times a day for 4 weeks in term1. Placebo food not containing plant constituents, feeding three times a day for 4 weeks in term2.
Placebo food not c
Sponsors
Suntory Global Innovation Center Ltd.
MetaGen, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy males aged 20 or more. 2)Subjects whose defecate between 3 to 5 times in a week in a week. 3)Subjects who don't take constantly use supplements and/or functional foods (including Food for Specified Health Uses and Foods with Function Claims) affecting the intestinal regulation, cholesterol, serum triglyceride, body fat. 4)Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Exclusion criteria
Exclusion criteria: 1) Subjects whose systolic blood pressure is less than 90 mmHg. 2) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. 3) Subjects who donated 200 mL of blood and/or blood components within four weeks prior to the current study. 4) Males whose blood was collected more than 400 mL within the last twelve weeks. 5) Females whose blood was collected more than 400 mL within the last twelve weeks. 6) Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks. 7) Subject who are applicable to one of the below. a) Subject who are contracting heart, liver or kidney disease including the case of complicating disease. b) Subjects with a previous history of cardiovascular disease. c) Subjects who are contracting diabetes. d) Subjects who have allergy to test food. 8) Males whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added. 9) Females whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added. 10) Subjects who underwent abdominal surgical operation within 6 month before test start. 11) Subjects who took antibiotics for 1 month or more within 6 month before test start. 12) Subjects who have an irregular sleep cycle, work shift or work on midnight shift. 13) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses, Foods with Function Claims). 14) Subjects who plan big change of lifestyle during test period. 15) Subjects with tendency of chronic diarrhea. 16) Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart. 17) Subjects who suspected chronic or acute infectious disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intestinal microflora | — |
Countries
Japan
Contacts
Public ContactKenichi Wakabayashi
Suntory Global Innovation Center Ltd. Innovation Development Department
Outcome results
None listed