Research on the overconsumption of dietary fiber-containing food.

UMIN ID: UMIN000056352

Registered date:06/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 2025/01/07
• Target sample size: 48
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Intake of fiber-containing food in amount exceeding the recommended daily intake for 4 weeks

Outcome(s)

• Primary Outcome: Safety of overconsumption of fiber-containing food

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 64years-old
• Gender: Male and Female
• Exclude criteria: (1) Subjects who take health foods related to the test food more than 1 day a week (2) Subjects who habitually take health foods that are expected to have effects that overlap with the product concept (3) Subjects with a medical condition that may affect the study (4) Subjects who have had abnormalities in clinical test values or cardiopulmonary function and are judged to be unsuitable for participation in the study (5) Subjects who are at risk of developing allergies related to the study (6) Subjects with a disease requiring regular medication, with a disease currently being treated (excluding dry eyes and tooth decay) or with a history of a serious disease that required medication (7) Subjects whose pre-intake test results are significantly outside the reference range (8) Subjects who work in shifts, late-night shifts, or have other irregular lifestyles (9) Subjects who have participated or plan to participate in other studies within one month of the start of the study or during the study (10) Females who are pregnant, potentially pregnant (only to wish to become pregnant during the study period), or breastfeeding (11) Subjects who are judged to be unsuitable for participation in the study based on their responses to the lifestyle questionnaire or pre-intake test results (12) Subjects who are judged as unsuitable for the study by the investigator for other reason

Related Information

• Primary Sponsor: EP Mediate Co., Ltd.
• Source(s) of Monetary Support: Kobayashi Pharmaceutical Co., Ltd.