Verification of the effects of test food on vascular endothelium functionality and gut environment

UMIN ID: UMIN000042014

Registered date:23/10/2021

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy men / female subjects
• Date of first enrollment: 2020/10/23
• Target sample size: 36
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

- Test food1: dietary capsule with 500 mg test ingredient. - 5 capsules will be taken with water per time per day for 12 weeks.
- Test food2: dietary capsule with 100 mg test ingredient. - 5 capsules will be taken with water per time per day for 12 weeks.
- Control food: dietary capsule without test ingredient. - 5 capsules will be taken with water per time per day for 12 weeks.

Outcome(s)

• Primary Outcome: Flow Mediated Dilation (FMD)
• Secondary Outcome: - Blood pressure (Systolic/Diastolic) - Reactive hyperemia peripheral arterial tonometry (RH-PAT) - Gut microbiota - Gut metabolites - Defecation characteristics (defecation frequency, No, of defecation, quantity, shape, color, incomplete evacuation, abdominal pain, fecal odor) - QOL Questionnaire - Laboratory test value

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: (1) Subjects who are currently receiving medication. (2) Subjects who have a plan or who have taken medication which would affects the trial result (drug for intestinal disorder, antihypertensive, laxative or antibiotics) within a month before the trial start. (3) Subjects who are regularly consuming food for specified health uses (FOSHU), food with function claims, supplement and/or health foods which would affects the trial results for more the 3 times per week. (4) Subjects who are breast-feeding, pregnant, and are planning pregnancy. (5) Subjects who have current medical history/anamnesis of severe cardiac, hepatic, renal or digestive diseases. (6) Subjects who are heavy use of alcohol. (7) Subjects who have history of smoking. If subject have quit smoking for more than a month prior to trial, the subject could be included. (8) Subjects with irregular life style and diet. (9) Subjects who have allergies to food or medication. (10) Subjects who are currently participating, or who have been participated to other study for medicine or food within the last 4 weeks of the trial, or who possibly participate to other clinical trial after agreement of this study. (11) Subjects who donated over 200mL blood and/or blood components within a month to the current study. (12) Males who donated over 400mL blood and/or blood components within the last 3 months to the current study. (13) Females who donated over 400mL blood and/or blood components within the last 4 months to the current study. (14) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study. (15) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study. (16) Others who have been determined ineligible by principal investigator or sub-investigator.

Related Information

• Primary Sponsor: CPCC Company Limited
• Source(s) of Monetary Support: Daicel Corporation