A Study of the effects of a test-food on gut microenvironment connected with immunity

UMIN ID: UMIN000051359

Registered date:21/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy male/female adults
• Date of first enrollment: 2023/06/21
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Ingestion of the test food to the subjects, two a day (at breakfast, lunch or dinner) for 12 weeks.
Ingestion of the placebo food to the subjects, two a day (at breakfast, lunch or dinner) for 12 weeks.

Outcome(s)

• Primary Outcome: Total amount of short chain fatty acids in feces (total amount of acetic acid, propionic acid, and n-butyric acid)
• Secondary Outcome: 1. Short chain fatty acids in feces (acetic acid, propionic acid, and n-butyric acid) 2. Intestinal flora 3. Organic acid in feces (lactic acid, succinic acid, iso-valeric acid, n-valeric acid, formic acid, iso-butyric acid) 4. Immunoglobulin-A in feces 5. Ammonia in feces 6. Spoiled products in feces 7. Water in feces 8. pH in feces 9. Activity of plasmacytoid dendritic cells (cluster of differentiation 123, blood-dendritic cell antigen 4, cluster of differentiation 86, human leukocyte antigen DR, cluster of differentiation 40, cluster of differentiation 80) in blood 10. Constipation assessment scale-mid term 11. Defecation status (the number of days, frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, fecal odor)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: Subjects - - (1) taking in affecting foods (e.g., L. lactis strain Plasma) over 3 times a week, (2) who have taken affecting medicines (e.g., antibiotic), within the last month before a pre-test, (3) who take affecting medicine (e.g., anti-histamine, multi-ingredient cold medication) over twice a week, (4) taking in a yogurt, probiotic beverage, dietary fiber-rich staple food (e.g., unpolished rice) over 3 times a week, (5) who had undergone appendectomy, (6) who have received the affecting surgery (e.g., colonoscopy) within half a year before the consent, (7) who will vaccinate within the last month before and during this study, (8) taking excessive alcohol, (9) with extremely irregular life rhythms (e.g., midnight work), (10) taking oral medication or medical diet, (11) being under a low-carb diet, (12) having below a meal a day (over a day a week), within the last month before a pre-test, (13) who will change their life style, dietary habit, and living environment (e.g., move) during this study, (14) being under another clinical test with a medicine or health food, or partook in that within 4 weeks before this study, or will partake in that after the consent, (15) with over 30.0 kg/m2 of BMI, (16) whose roomer is planning to partake in this study, (17) with previous/current medical history of severe cardiac, hepatic, renal or digestive diseases, (18) with pregnancy, possibly one, or lactating, (19) having drug and food allergy (wheat, egg, milk and soybean), (20) who donated their blood components or blood (0.2 L) within the last month, (21) who donated his blood (0.4 L) within the last 3 months, (22) who donated her blood (0.4 L) within the last 4 months, (23) being collected in total of his blood (1.2 L) within the last 12 months and in this study, (24) being collected in total of her blood (0.8 L) within the last 12 months and in this study, (25) who have been determined as ineligible for participation, by the principal/sub doctor - - .

Related Information

• Primary Sponsor: CPCC Company Limited
• Source(s) of Monetary Support: Nisshin Seifun Group Inc.