Tokyo, Oct. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058145) titled 'Investigation of the Immunomodulatory Effects of Continuous Consumption of the Test Supplement - A Randomized, Double-Blind, Parallel-Group Comparative Trial' on Oct. 12.
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 evaluate the effects of 12 weeks of test supplement consumption on immune function in men and women aged 20 to under 70.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Daily intake of 5 tablets and 1 powder sachet after breakfast (placebo).
Interventions/Control_2 - Daily intake of 5 tablets and 1 powder sachet after breakfast (Intervention Group 1: low dose).
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Age: 20 to under 70 years.
2. Japanese men and women.
3. BMI between 18.5 kg/m^2 and 30.0 kg/m^2.
4. History of at least one upper respiratory tract infection per year.
5. Ability to input data into an electronic diary via smartphone or PC.
6. Voluntary participation with written informed consent after receiving a thorough explanation of the study's purpose and details.
Key exclusion criteria - 1. Currently undergoing treatment for any disease with medication or herbal remedies (occasional use allowed).
2. Under medical supervision for dietary or exercise therapy.
3. Current or history of severe diseases.
4. Diagnosed with atopic dermatitis, allergic rhinitis (seasonal or perennial), bronchial asthma, chronic bronchitis, or other immune-related disorders
5. Consumes yogurt, lactic acid bacteria, or bifidobacteria beverages three or more times per week.
6. Habitually drinks milk (including low-fat milk) three or more times per week.
7. Lactose intolerant
8. Regularly consumes over-the-counter drugs, functional foods, health foods, or supplements three or more times per week (eligible if discontinued after consent acquisition).
9. Received a vaccine for influenza, COVID-19, or other infections within one month prior to the first visit or plans to receive one during the study period.
10. Current or history of drug or food allergies.
11. Irregular lifestyle due to night shifts or rotating shifts.
12. Plans to significantly change lifestyle habits (diet, sleep, exercise, etc.) during the study period.
13. Heavy alcohol consumption (>=40g/day of alcohol).
14. Plans for overseas travel during the study period.
15. Pregnant, breastfeeding, or planning to become pregnant during the study period.
16. Blood donation exceeding 200 mL within one month or 400 mL within three months prior to screening.
17. Participation in another clinical study within one month prior to consent acquisition, currently participating, or planning to participate during the study period.
18. Considered unsuitable for participation by the principal investigator or sub-investigator.
Target Size - 60
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 05 Month 12 Day
Date of IRB - 2025 Year 05 Month 27 Day
Anticipated trial start date - 2025 Year 07 Month 19 Day
Last follow-up date - 2025 Year 10 Month 12 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066441
Disclaimer: Curated by HT Syndication.
