Tokyo, Nov. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059504) titled 'Evaluation of the efficacy of continuous consumption of the study food on immune function
- A randomized, placebo-controlled, double-blind, parallel-group study -' on Nov. 4.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - IMEQRD Co. Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To assess the impact of four weeks of study food intake on immune function in men and women aged 20 to under 60 years
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Consume one 65 mL bottle of the test beverage once each morning
Interventions/Control_2 - Consume one 65 mL bottle of the placebo beverage once each morning
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Aged 20 to under 60 years
2. Japanese men and women
3. Have contact with others at least once a week through work or social activities
4. History of upper respiratory tract infection at least once a year
5. BMI 18.5 or more, and less than 30.0 kg/m^2
6. Able to enter electronic diaries via smartphone or PC
7. Received thorough explanation of study purpose and details, fully understood, voluntarily agreed to participate, and provided written consent
Key exclusion criteria - 1. Currently receiving outpatient treatment or medication (including herbal medicine) for any illness (as-needed use permitted)
2. Under physician-supervised dietary or exercise therapy
3. Current or past history of serious disease
4. Atopic dermatitis, allergic rhinitis (seasonal or perennial), bronchial asthma, chronic bronchitis, or other immune-related disorders
5. Consuming yogurt or foods containing lactic acid bacteria or bifidobacteria (eligible if discontinued after consent)
6. Currently taking quasi-drugs, Foods for Specified Health Uses, health foods, or supplements (eligible if discontinued after consent)
7. Lactose intolerance
8. Received vaccination for influenza, COVID-19, etc., within one month before screening visit, or plans to be vaccinated during study period
9. Current or past history of drug or food allergies
10. Irregular lifestyle due to night shifts or other shift work
11. Plans to significantly change lifestyle habits (diet, sleep, exercise, etc.) during study period
12. Excessive alcohol consumption (>=40 g pure alcohol per day)
Target Size - 200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 05 Day
Date of IRB - 2025 Year 09 Month 30 Day
Anticipated trial start date - 2025 Year 11 Month 05 Day
Last follow-up date - 2026 Year 03 Month 02 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067859
Disclaimer: Curated by HT Syndication.
