Healthy adults
Conditions
Interventions
Consume cookies containing plant-derived ingredient A and beverages containing plant-derived ingredient B for 4 weeks. After washout, placebo cookies and placebo beverages will be consumed for 4 weeks
Sponsors
KAGOME CO., LTD./ FUJI OIL HOLDINGS INC.
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy Japanese men and women between the ages of 20 and less than 60 years old at the time of consent acquisition. 2) Subjects who defecate 3-5 times per week. 3) Non-smokers 4) Subjects who regularly consume three meals a day. 5) Subjects who have been fully informed of the purpose and content of the research, have the capacity to consent, and have voluntarily volunteered to participate in the research based on a good understanding of the purpose and content of the research, and have agreed to participate in the research in writing.
Exclusion criteria
Exclusion criteria: 1) Subjects who regularly use laxatives, bowel preparation, etc. 2) Subjects who are visiting the hospital for treatment of disease or receiving medication. 3) Subjects who have taken antibiotics within 1 month of the screening test. 4) Subjects who take protein powder or protein-fortified foods. 5) Subjects who take health foods fortified with dietary fiber (including food for specified health use, functional foods, health supplements, and nutritional supplements) 6) Subjects who consume foods containing live bacteria such as lactobacilli, bifidobacteria, and bacillus natto, oligosaccharides, and other foods good for improving constipation and the intestinal environment, and foods containing large amounts of sugar alcohol at least 3 times a week. 7) Subjects who cannot avoid consuming protein powder, protein-fortified foods, and foods fortified with dietary fiber during the study period. 8) Subjects who are unable to maintain their pre-study eating and lifestyle habits with regard to diet, exercise, and sleep throughout the study period. 9) Subjects who have difficulty with the protein bar itself, bitter taste, or taste of mixed vegetable juice (tomato/carrot mixed juice). 10) Subjects who reported having food allergies. 11) Subjects who drink excessive amounts of alcohol on a daily basis (more than 20 g/day of pure alcohol equivalent three times or more per week). 12) Subjects who have smoked in the past year. 13) Subjects who are pregnant, intend to become pregnant during the study period, or are breastfeeding. 14) Subjects whose menstrual cycle changes significantly each time, subjects undergoing treatment for menopausal disorders. 15) Subjects who have participated, are participating, or intend to participate after obtaining consent, in research using other foods or drugs during the month prior to obtaining consent. *Items numbered 16 and thereafter are listed in the other related information section.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal microflora analysis, organic acid analysis in stool, polyamine analysis in stool | — |
Secondary
| Measure | Time frame |
|---|---|
| Defecation status, Questionnaire on physical condition, MOS Short-Form 36-Item Health Survey | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Clinical Trial Management Department
Outcome results
None listed