Tokyo, Aug. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058789) titled 'Verification research for the minimum effectiveness of the test food' on Aug. 13.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - BIOSIS Lab. Co., Ltd.
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Identify the minimum effectiveness of the test food
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intake 4 g of test food every day for 4 weeks.
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1. Persons who are aged 18 to 100 at the time of consent, both men and women
2. Persons who are not suffering from intestinal diseases (including those who are judged not to require immediate treatment)
3. Persons who received a sufficient explanation of the purpose and contents of the research, have the capacity to consent
Key exclusion criteria - 1. Persons who may experience abdominal pain when eating ingredients containing dietary fiber, such as Barley Max
2. Persons who have been diagnosed with a digestive disease, previously undergone digestive surgery, and will require digestive surgery in the future
3. Persons who regularly use (at least 3 days a week) ingredients containing ingredients containing dietary fiber, such as Barley Max, or have regularly used within the 3 months prior to the pre-test
4. Persons who have been diagnosed with malignant tumors, currently receiving treatment for cranial nerve, heart, kidney, diabetes, or thyroid dysfunction, and with a history of serious illnesses such as liver disease, excluding illnesses like hypertension, which the principal investigator determined will not affect the evaluation of the research.
5. Persons who drink a large amount of alcohol (60 g or more of alcohol per day: approximately 1500 mL of beer, 540 mL of wine, 3 cups of sake, or 180 mL of double-sized whiskey)
6. Persons who are at risk of developing allergies related to the test food, such as those with wheat or barley allergies
7. Persons who are judged unsuitable as research subjects based on their responses to a background survey
8. Persons who have participated in other research during one month prior to the start of this research, or plan to participate in other research after consenting to this research.
9. Persons who are judged to be ineligible by the principal investigator
Target Size - 20
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 12 Month 28 Day
Date of IRB - 2024 Year 12 Month 28 Day
Anticipated trial start date - 2025 Year 01 Month 01 Day
Last follow-up date - 2025 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067224
Disclaimer: Curated by HT Syndication.
