Tokyo, Aug. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058745) titled 'A Study on the Immunostimulatory Effects of the Test Food -A Randomized, Double-blind, Parallel-group Study-' on Aug. 19.
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 examine the effects of the test food on immune function, primarily IgA, in healthy adults for eight weeks.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Consumption of the test food (1 pack a day, 8 weeks)
Interventions/Control_2 - Consumption of the placebo food (1 pack a day, 8 weeks)
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Participants aged 20 to 64 years
2. Japanese men and women
3. BMI over 18.5 and less than 30.0 kg/m^2
4. History of upper respiratory tract infection at least once per year
5. Able to enter electronic diaries via smartphone or PC
6. Sufficiently informed about the study and voluntarily consented in writing
Key exclusion criteria - 1. Currently receiving treatment for any disease with medication or Kampo (as-needed use allowed)
2. Under physician-supervised dietary or exercise therapy
3. History or presence of serious illness
4. History of gastrointestinal surgery (except appendicitis)
5. Atopic dermatitis, allergic rhinitis (seasonal/perennial), bronchial asthma, chronic bronchitis, or other immune-related diseases (e.g., autoimmune diseases)
6. Current or past treatment for dry mouth or Sjogren's syndrome
7. Consumes yogurt, lactic acid bacteria, or bifidobacteria foods at least 3 times per week, or unwilling to refrain during the study
8. Currently taking quasi-drugs, FOSHU, FFC, supplements, or health foods (allowed if discontinued after consent)
9. Plans to use drugs affecting immune function or gut flora (e.g., antiallergics, antibiotics) during the study
10. Vaccinated against influenza, COVID-19, etc., within 1 month before consent, or plans to be vaccinated during the study
11. Participants with current or past drug or food allergies
12. Irregular lifestyle due to night or shift work
13. Plans to significantly change lifestyle (diet, sleep, exercise) during the study
14. Heavy alcohol consumption (more than or equal to 40g per day)
15. Excessive smoking (more than or equal to 21 cigarettes per day)
16. Plans for overseas travel during the study
17. Pregnant, breastfeeding, or planning pregnancy during the study
18. Currently using or planning to use oral contraceptives during the study
19. Donated more than 200mL of blood within 1 month or more than 400mL within 3 months before consent
20. Participated in other clinical studies within 1 month before consent, currently participating, or planning to participate during the study
21. Considered unsuitable for participation by the principal or sub-investigator
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 08 Day
Date of IRB - 2025 Year 07 Month 15 Day
Anticipated trial start date - 2025 Year 10 Month 15 Day
Last follow-up date - 2025 Year 12 Month 12 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066893
Disclaimer: Curated by HT Syndication.
