Clinical Trial: A randomized, 2 groups crossover comparison study on the effects of continuous intake of supplements containing mushroom-derived ingredients on human immune function and others (Japan)

Tokyo, March 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000053325) titled 'A randomized, 2 groups crossover comparison study on the effects of continuous intake of supplements containing mushroom-derived ingredients on human immune function and others' on March 31.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Placebo

Primary Sponsor: Institute - National Agriculture and Food Research Organization

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

Objective: Narrative objectives1 - To investigate the effects of continuous intake of mushroom-derived ingredients on human immune function and others Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - 8 tablets/day of Supplements containing mushroom-derived ingredients intake for 4 weeks Interventions/Control_2 - 8 tablets/day of Placebo tablet intake for 4 weeks

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Japanese men and women aged 20 years or older at the time of registration (As a general rule, only workers). 2.Those who are aware that they tend to get sick during winter or when seasons change (Priority will be given to those who have had two or more upper respiratory tract infections within the past year.) 3.Those who do not have any disease receiving continuous treatment, medication, and lifestyle guidance. 4.Those who do not plan to take drugs (including over-the-counter drugs) for allergic diseases such as hay fever, bronchial asthma, or chronic bronchitis during the research period. 5.Those who can respond to electronic diaries and questionnaire surveys on a PC 6Those who can use Excel, Word, and online meeting tools 7.Those who are able to report daily on test food intake status and physical condition using an electronic diary. 8.Priority will be given to those who have not been vaccinated within the past month and have no plans to be vaccinated during the trial period. 9.Those who received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent. Key exclusion criteria - 1.Those who are receiving any types of medicines and/or Chinese medical treatment except a dose of medicine taken only once. 2.Those who had been experiencing a severe disease. 3.Those who have a drug/food allergy. (Those who may have an allergic reaction when ingesting the test food) 4.Those who have currently been taking commercially available drugs, quasi-drug products, and foods or supplements with functional claims. However, those who can discontinue taking these foods during the trial period after obtaining informed consent will be allowed to join the trial. 5.Those who drink more than 60 g alcohol/day. 6.Those who have excessive smoking habits (21 or more cigarettes/day). 7.Those who frequently have to redo of blood for medical examinations, and who have felt unwell due to blood collection in the past. 8.Those who work on the shiftwork. 9.Those who have plans of major change on their lifestyle (e.g. diet, sleep and exercise) during the study period. 10.Those who are planning to travel abroad during the study period. 11.Those who have joined other clinical trials in the past 1 month before receiving informed consent in this study, or are currently joining other clinical trials, or are planning to join other clinical trials. 12.Women who are pregnant or may become pregnant, or lactating. 13.Those who are unsuitable for this trial that judged by the principal investigator. Target Size - 80

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2023 Year 09 Month 21 Day Date of IRB - 2023 Year 09 Month 21 Day Anticipated trial start date - 2023 Year 10 Month 27 Day Last follow-up date - 2024 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060868

Disclaimer: Curated by HT Syndication.