Tokyo, March 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061081) titled 'Investigation of the effects of food intake on allergic symptoms' on March 27.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Macromill, Inc.
Condition:
Condition - Healthy Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of food intake on allergic symptoms through a single-arm, open-label study.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - 8-week intake of the test food . Take 2 tablets with water or lukewarm water once a day at breakfast
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - (1) Japanese healthy male and female adults aged 20 years or older and under 65 years at the time of informed consent.
(2) Individuals who have owned dogs or cats for at least 1 year.
(3) Individuals who perceive themselves to have allergic symptoms likely caused by dogs or cats.
(4) Individuals who fully understand the purpose and content of the study and agree to participate of their own free will.
Key exclusion criteria - (1) Individuals who regularly use medicines or quasi-drugs related to allergies.
(2) Individuals at risk of developing allergies related to the study or the study food.
(3) Individuals with nasal diseases (nasal polyps, hypertrophic rhinitis, acute or chronic rhinitis, deviated nasal septum, sinusitis, perennial rhinitis) to an extent that interferes with the evaluation of efficacy.
(4) Individuals with diseases requiring constant medication (external or internal), individuals under treatment for diseases (excluding dry eye and dental caries treatment), or individuals with a history of serious diseases requiring medication.
(5) Individuals with irregular lifestyle rhythms, such as shift work or late-night work.
(6) Heavy drinkers.
(7) Smokers.
(8) Individuals with a history of abnormal clinical laboratory values or cardiopulmonary function, or a history of diseases or surgeries that may cause diabetes, glucose metabolism disorders, or lipid metabolism disorders, such as pancreatic disease, endocrine disease (including thyroid-related diseases), liver disease, or gastrectomy, and who are judged to have problems participating in the study.
(9) Individuals who have participated in other clinical studies or trials within 1 month prior to the date of informed consent. (10) Individuals who expect significant changes in their living environment during the study period (travel or business trips of 1 week or more, relocation, transfer, etc.).
(11) Individuals with extremely irregular eating habits.
(12) Individuals judged inappropriate as study subjects by the principal investigator based on background information, pre-test results, or other reasons.
(13) Individuals who are pregnant or may be pregnant, breastfeeding, or wish to become pregnant during the study period.
(14) Others judged inappropriate as study subjects by the principal investigator.
Target Size - 48
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 27 Day
Anticipated trial start date - 2026 Year 04 Month 08 Day
Last follow-up date - 2026 Year 09 Month 05 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069723
Disclaimer: Curated by HT Syndication.
