Tokyo, Sept. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063041) titled 'Effects of Continuous Test Food Intake on Bowel Movements: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study' on Sept. 28.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Macromill Carenet, Inc.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of six-week continuous intake of the test food on bowel movements, a randomized, double-blind, placebo-controlled, parallel-group trial will be conducted in healthy males and females aged 20 to under 65 years who have a tendency toward constipation and abdominal discomfort.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - 6-week intake of test food
Interventions/Control_2 - 6-week intake of placebo food
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Healthy Japanese males and females aged 20 years or older and under 65 years at the time of informed consent.
2. Individuals with a tendency toward constipation (usual defecation frequency of 3 to 5 times per week).
3. Individuals with abdominal discomfort.
4. Individuals who have received sufficient explanation of the study, have the capacity to provide informed consent, fully understand the study, and are able to provide electronic informed consent.
Key exclusion criteria - 1. Regular use of drugs that affect bowel movements (laxatives, antidiarrheals, etc.).
2. Undergoing treatment for hemorrhoids or experiencing severe pain or bleeding during defecation.
3. Chronic diseases currently under treatment.
4. A history of serious cerebrovascular, heart, liver, kidney, blood, or endocrine diseases.
5. A history of serious gastrointestinal diseases, such as intestinal obstruction or malignancy, or gastrointestinal surgery (e.g., gastrectomy, intestinal suturing, or enterectomy), excluding appendectomy.
6. Diagnosed with or treated for axillary osmidrosis or hyperhidrosis.
7. Risk of allergy to test foods.
8. Individuals whose bowel movements are substantially affected by menstruation or poor physical condition.
9. Unable to stop fermented milk or lactic acid bacteria beverages during the trial.
10. Unable to stop foods for specified health uses, functional foods, or health foods during the trial.
11. Current smokers.
12. Habitual drinkers (approx. 60g alcohol per day).
13. Extremely irregular sleep or diet (shift or night workers).
14. Potential major changes in living environment, diet, or exercise during the trial.
15. Women who are breastfeeding, pregnant, potentially pregnant, or planning pregnancy.
16. Current, recent (within 4 weeks of screening), or planned participation in other clinical trials.
17. Judged inappropriate by the principal investigator.
Target Size - 120
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 17 Day
Date of IRB - 2026 Year 09 Month 17 Day
Anticipated trial start date - 2026 Year 09 Month 28 Day
Last follow-up date - 2026 Year 12 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072110
Disclaimer: Curated by HT Syndication.
