Validation study about test food-ingesting effects on visceral fat area and gut microenvironment

Not Applicable

• Conditions: Healthy male/female adults

• Registration Number: JPRN-UMIN000044908
• Lead Sponsor: CPCC Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-12-05
• Study Start: 2022-07-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects - - (1) with dieting (exercise, meal-control), or going on, (2) taking in affecting foods (obesity/gut/ immuno-regulation, not less than 3 times a week, (3) with excessive alcohol intake, (4) who have taken affecting medicines (allergic/gut/laxative/obesity/antibiotic regulation) within the last month before the test-food intakes, (5) with history of appendix removal, (6) who have received affecting surgeries (colonoscopy, gallstones/gall bladder removal, gastric bypass) within half a year before the consent, (7) planning to change their present life style and dietary habit, (8) with extremely irregular dietary habit, (9) with the roomer planning to participate in this study, (10) restricting their mealtimes to no more than once a day (not less than once a week), within the last month, (11) with medical history of serious diseases, (12) with a continuous medical treatment, (13) with not less than 6.5 % HbA1c, (14) with not less than 126 mg/dL of hungry blood-sugar level, (15) with not less than 25.0 kg/m2 of BMI and not less than 100 cm2 of abdominal fat area, (16) with pregnancy, possibly one, or lactating, (17) with drug/food allergy (wheat, egg, milk), (18) being under the other clinical tests (medicine or health food), or took part in those within the last 4 weeks, or will join those after the consent, (19) who donated their blood components or blood (0.2 L) within the last month, (20) who donated his blood (0.4 L) within the last 3 months, (21) who donated her blood (0.4 L) within the last 4 months, (22) being collected in total of his blood (1.2 L) within the last 12 months and in this study, (23) being collected in total of her blood (0.8 L) within the last 12 months and in this study, (24) being determined as ineligible by the principal/sub investigator - - .

Study & Design

• Study Type: Interventional
• Study Design: Not specified