Clinical Trial: A Study on the Effects of a Test Food on Immune Markers and the Gut Microbiome, as Well as Its Impact on Cold Symptoms - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Trial - (Japan)

Tokyo, Oct. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063121) titled 'A Study on the Effects of a Test Food on Immune Markers and the Gut Microbiome, as Well as Its Impact on Cold Symptoms - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Trial -' on Oct. 5.

Study Type: Interventional

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

Primary Sponsor: Institute - TES Holdings Co., Ltd.

Condition: Condition - No Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to investigate the effects of continuous consumption of the test food on immune markers and the gut microbiome, as well as its impact on cold symptoms. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Oral ingestion of a test food (3 capsules in a day; 8 weeks). Interventions/Control_2 - Oral ingestion of a control food (3 capsules in a day; 8 weeks).

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1) Men and women who are 20 years of age or older but under 65 at the time consent to participate in the study is obtained. 2) Healthy individuals with no chronic physical illnesses. 3) Individuals who experience physical or mental fatigue in their daily lives. 4) Individuals who are prone to feeling unwell due to cold symptoms (fever, cough, sore throat, runny nose, nasal congestion, etc.) 5) Individuals who have received a thorough explanation of the study's purpose and content, possess the capacity to give informed consent, have voluntarily agreed to participate after fully understanding the study, and are able to provide written consent to participate in the study. 6) Individuals who are able to visit the facility on the designated examination date and undergo the examination. 7) Individuals deemed suitable for participation in the study by the principal investigator. Key exclusion criteria - Individuals 1) with chronic fatigue. 2) who have fewer than three spontaneous bowel movements per week. 3) suffering from any medical condition and currently undergoing drug therapy. 4) with a current history of mental illness, sleep disorders, hypertension, diabetes, dyslipidemia, or autoimmune diseases; or individuals with a history of serious illnesses, whether past or present. 5) with a history of serious conditions affecting the liver, kidneys, heart, lungs, blood, or digestive system. 6) who within the past month, have taken or applied medications for the purpose of treating a medical condition. 7) who regularly take medications that affect the gut microbiome. 8) with a BMI of 30 kg/m2 or higher. 9) who may experience allergic reactions to ingredients in the test food, other foods, or medications. 10) whose daily alcohol consumption exceeds an average of 40 g per day for men and 20 g per day for women, calculated on a weekly basis. 11) who may develop perennial or seasonal allergy symptoms, such as hay fever, and require oral medication during the study. 12) who are scheduled to receive a vaccination during the study period. 13) who may change their lifestyle habits during the trial period. 14) currently or recently (within the past 3 months) regularly consuming health functional foods, health foods, or supplements, or planning to consume them during the study. 15) who have donated whole blood or blood components in an amount exceeding 200 mL within the past month or 400 mL within the past three months. 16) who are pregnant, breastfeeding, or who may be pregnant, or who intend to become pregnant during the study period. 17) currently participating in another human clinical trial, or who participated in one within the past 3 months. 18) who, or whose family members, are employed by companies that develop, manufacture, or sell health or functional foods and cosmetics. 19) Any other individuals deemed ineligible for this trial by the principal investigator. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 19 Day Date of IRB - 2026 Year 08 Month 24 Day Anticipated trial start date - 2026 Year 10 Month 15 Day Last follow-up date - 2026 Year 12 Month 15 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071756

Disclaimer: Curated by HT Syndication.