Verification of the effect of test foods on the intestinal environment

UMIN ID: UMIN000054328

Registered date:07/05/2024

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: non-handicapped person
• Date of first enrollment: 2024/05/07
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Testfood intake(2weeks) to washout period(2weeks) to Placebo intake(2weeks)
Placebo intake(2weeks) to washout period (2weeks) to Testfood intake(2weeks)

Outcome(s)

• Primary Outcome: Frequency of defecation
• Secondary Outcome: Visual Analogue Scale EEG Autonomic Activity Assessment

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: 1,Those who have a bowel movement every day 2,Those who are receiving treatment (including medication) for some disease at a medical institution 3,Those who have a current or previous serious disease 4,Those who are taking intestinal regulators or laxatives on a daily basis 5,Those who routinely consume food for specified health use, functional foods, yogurt, or lactic acid bacteria beverages that are thought to be involved in intestinal regulation 6,Those who habitually take supplements or nutrient-fortified foods on a daily basis 7,Those who have drug allergy or food allergy or have a history of such allergy (Those who are at risk of developing allergic symptoms to the test food) 8,Those who have participated or are currently participating in other clinical trials within 1 month of obtaining consent, or those who plan to participate during the study period 9,Those who have an irregular rhythm of life, such as shift work, late-night work, etc. 10,Those who drink a lot of alcohol on a daily basis (alcohol equivalent to 60g/day) 11,Smoking 12,Patients who are judged to be inappropriate for this study by the investigator 13,BMI less than 18.5 or greater than 25

Related Information

• Primary Sponsor: Fuji Nihon Seito Corporation
• Source(s) of Monetary Support: Fuji Nihon Seito Corporation