Tokyo, Aug. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058690) titled 'Evaluation of the Effect of Study Food Consumption on Bowel Movement Frequency' on Aug. 29.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Male/female adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effect of consuming the study food for two weeks on bowel movement frequency.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Oral consumption of one test food, once daily for 14 days
Interventions/Control_2 - Oral consumption of one placebo food, once daily for 14 days
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Male and female aged 20 to below 65 years at the time of consent acquisition.
2. Individuals with a bowel movement frequency of five times or fewer per week.
3. Individuals who are able to receive the study food once a week.
4. Individuals able to consume one unit of the study food per day.
5. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria - 1. Individuals who consume Foods for Specified Health Uses, Foods with Function Claims, or other health foods or supplements that may affect the intestinal environment more than twice a week.
Individuals who consume such products once a week or less but are unable to discontinue their use from the time of consent acquisition.
2. Individuals who consume yogurt, lactic acid bacteria drinks, or staple foods high in dietary fiber (e.g., brown rice, barley, whole-grain bread, cereals, and foods with nutritional claims that are not classified as Foods for Specified Health Uses or Foods with Function Claims) more than three times a week
3. Individuals who consume alcohol more than three times per month or who consume more than 60 g of alcohol per drinking occasion.
4. Individuals who had days with fewer than 1 meal per day more than once a week within 1 month before the preliminary examination.
5. Individuals on carbohydrate-restricted or weight-loss diets.
6. Individuals with extremely irregular lifestyles (e.g., night shift workers or those with irregular rotating shifts).
7. Individuals with a BMI of 30.0 kg/m2 or higher.
8. Individuals who plan to change their current lifestyle, dietary habits, or living environment (e.g., moving, job transfers, overseas travel or business trips) during the study period.
9. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
10. Individuals whose cohabiting family members are also scheduled to participate in this study.
11. Individuals with a history of appendectomy.
Target Size - 76
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 05 Month 19 Day
Date of IRB - 2025 Year 05 Month 16 Day
Anticipated trial start date - 2025 Year 06 Month 25 Day
Last follow-up date - 2025 Year 10 Month 15 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066211
Disclaimer: Curated by HT Syndication.
