Tokyo, Oct. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059489) titled 'Investigation of the effects of the processed sweet potato products on the regulation of intestinal function' on Oct. 24.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Kagoshima Immaculate Heart University

Condition: Condition - Healthy adult Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigation the effect of test foods on the regulation of intestinal function in healthy Japanese subjects Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intake of test foods for 4 weeks (100g/ day)

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - (1) Healthy adult males and females between 20 to 65 years (2) BMI: less than 30 kg/m2 (3) Subjects who have a tendency toward constipation (4)Subjects who have received sufficient explanation about the purpose and content of the examination, have the ability to consent, have a good understanding, volunteered to participate and agreed to participate in the examination in writing Key exclusion criteria - (1) Subjects who were diagnosed with liver disease, kidney disease, gastrointestinal disease, heart disease, diabetes, or other diseases that may affect the results of this study, or who have a history of surgery (2) Subjects who indicate abnormal parameter in liver or kidney function (3) Subjects with a disease currently under treatment (4) Subjects with anemia (5) Subjects who detect abnormal values by blood test (6) Subjects who determine ineligible by principal investigator (7) Subjects with drug or food allergies (8) Subjects who play high intensity sports and/or are on a diet (9) Subjects who can't stop using functional foods (including Food for Specified Health Uses or Foods with Function Claims) and/or Specified quasi-drugs during the current study periods (10) Subjects who are under treatment with medications (including OTC or prescribed medication) (11) Subjects who drink excessive alcohol, or who can't stop drinking from one day before each measurement (12) Subjects with smoking habit (13) Subjects with irregular life patterns and lifestyle of reversal of day and night (14) Subjects who have a habit of excessive eating and drinking (15) Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period (16) Subjects who is participating in the other study or planning to participate during the study period (17) Subjects who has taken the blood sampling more than 200 mL within 1 month, or plan the blood sampling during the study period Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 14 Day Date of IRB - 2025 Year 10 Month 14 Day Anticipated trial start date - 2025 Year 10 Month 24 Day Last follow-up date - 2025 Year 12 Month 26 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068043

Disclaimer: Curated by HT Syndication.