Tokyo, Feb. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060580) titled 'Research on the effects of fermentable dietary fiber intake and behavioral intervention on bowel movements' on Feb. 4.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Healthcare Systems Co., Ltd.
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects on bowel movements of adult aged 20 to under 50 years old who take in foods containing fermented dietary fiber and undergo behavioral intervention (intestinal massage) for 4 consecutive weeks.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intake of foods containing fermented dietary fiber and behavioral intervention (intestinal massage) for 4 weeks.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Japanese who are 20 years old or more and under 50 years old
3. Persons who had 3 or more bowel movements per week but fewer than 21 bowel movements per week during screening
Key exclusion criteria - 1. Persons who have chronic illness, receiving medication, have a serious disease history
2. Persons who are allergic to the test food (especially wheat, eggs, milk, soybeans, peaches, almonds, and oranges)
3. Persons who usually take a large amount of test food
4. Persons who regularly do intestinal massages
5. Persons who usually take a large amount of dietary fiber
6. Persons who usually take medicine, health functional foods, or other foods expected to have prebiotic or probiotic effects that may influence bowel movements or the intestinal environment.
7. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
8. Persons who were judged as inappropriate for study participants by the principal investigator
9. Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target Size - 150
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 04 Day
Anticipated trial start date - 2026 Year 02 Month 09 Day
Last follow-up date - 2026 Year 04 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069292
Disclaimer: Curated by HT Syndication.