Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062004) titled 'A study to confirm the effect on immunity by intake of high dietary fiber wheat flour-containing foods' on June 30.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Nisshin Seifun Group Inc.

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

Objective: Narrative objectives1 - To confirm the immunostimulatory effect of intaking the study food for 12 weeks Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Consecutive intake of study food twice a day, replacing one piece a time with staple food for 12 weeks Interventions/Control_2 - Consecutive intake of control food twice a day, replacing one piece a time with staple food for 12 weeks

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - (1)males and females from 20 to 64 years of age (2)Those who are aware that they are prone to catching colds (3)Those with no more than 5 bowel movements per week in the 2 weeks after the pre-examination (4)Those who are aware of fatigue (5)Those who are able to consume study food as a staple food twice a day (6)Those who are able to receive and freeze the study food (7)Those who are able to consume study food appropriately (8)Those who have fully comprehended the purpose and content of this study and provide informed consent to participate voluntarily Key exclusion criteria - (1)Those who have a disease requiring constant medication, those with a disease under treatment, or those with a history of a serious disease that required medication (2)Those suffering from gastrointestinal diseases, or who have a history of previous illnesses or surgeries (3)Those with pre-existing conditions that require diet and exercise therapy under the guidance of a doctor (4)Those who having atopic dermatitis, bronchial asthma, and chronic bronchitis (5)Those who may be taking medicine or undergoing treatment for hay fever or allergic rhinitis (6)Those who are taking medicines, health foods that may affect immune function or bowel movements at least 3 times a week (7)Those who have reported allergies to food or medicines (8)Those who are unable to prohibit the intake of foods that may affect the outcome of this study (9)Those who consume foods high in fiber at least 3 times a week (10)Those who vaccinated within 4 weeks or hope for vaccination (11)Heavy drinkers of alcohol (12)Heavy excessive smokers (13)Those who are planning to travel overseas (14)Those who are becoming pregnant and lactating or intend to become pregnant (15)Night and day shift worker (16)Those whose cohabitants plan to participate in the study (17)Those who plan to change their lifestyle, eating habits, or living environment (18)Those that dietary habits are irregular (19)Those who had one meal or less per day at least once a week (20)Those who are on a carbohydrate restriction or diet (21)Those who have collected 200 mL of blood within 1 month or more than 400 mL within 3 months (22)Those who have participated in other clinical studies within one month or plan to participate (23)Those whose pre-examination results are judged as unsuitable for the subject (24)Those who are judged as unsuitable for the subject by the investigator Target Size - 76

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 28 Day Date of IRB - 2026 Year 05 Month 28 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2026 Year 12 Month 09 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070949

Disclaimer: Curated by HT Syndication.